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Efficacy Trial of a Dissonance Based Eating Disorder Program

Efficacy Trial of a Dissonance Based Eating Disorder Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03796091
Enrollment
180
Registered
2019-01-08
Start date
2018-11-18
Completion date
2021-04-15
Last updated
2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorder

Brief summary

The purpose of this clinical trial is to investigate whether symptoms of disordered eating change among participants who complete an intervention. Participants will be randomly assigned to one of three intervention conditions and will undergo assessments of symptoms before, after, and 2 months after each intervention. Investigators are evaluating which interventions are most effective in reducing eating disorder symptoms and disorder-related psychological and cardiac risk factors.

Detailed description

Assessment Sessions (Preintervention, Postintervention, 2-month follow-up): Participants in all conditions will participate in a series of 3 assessment sessions. Prior to each session, participants will complete online questions assessing eating disorder symptoms and associated psychological risk factors. This process will take approximately 40 minutes. Next participants will report to the laboratory at their scheduled appointment time to have their cardiac function assessed via blood pressure measurements and electrocardiography (EKG or ECG). Participants' height and weight will also be recorded. Prior to each assessment session, participants should: * Complete the online survey (if not completed prior to each laboratory appointment this will need to be completed at the lab appointment) * Fast (not consume any food or beverages other than water) for at least 3 hours. * Refrain from using nicotine for at least 3 hours. * Refrain from vigorous physical exercise for at least 24 hours. * Not show any symptoms of acute physical illness for 48 hours. It is important for participants to follow these directions so researchers can gather the most accurate data. If participants forget to follow these guidelines, or if an illness occurs, participants should contact their experimenter to reschedule. On the day of an assessment session, participants will drive to the assessment location. Participants will receive directions via e-mail prior to each session. During the assessment session, participants will lie down on a laboratory cot for 10 minutes while preparation for electrocardiography (EKG or ECG) occurs. Electrodes will be applied to the chest and torso and lead wires will be attached to the electrodes. Participants' blood pressure will be assessed several times throughout this interval. Next, the experimenter will collect a 5 minute and 30 second recording of participants' cardiovascular data via electrocardiography (ECG or EKG). This data will later be analyzed to examine cardiac function.Next experimenters will assess participants' height and weight. After each assessment session, participants' eating disorder symptoms, psychological risk factors, and cardiac indices will be evaluated by the research team. If the team determines that symptoms or cardiac indices are atypical and indicate a further need for evaluation, the participant will be contacted via both e-mail and phone to be informed results are atypical and the participant will be referred for further evaluation by a medical provider. If the participant is a minor, this information will be provided both to the participant and to the participant's parent and/or the participant's legal guardian. If participants' symptoms or risk factors worsen significantly over the duration of the trial, participants will also be contacted and provided with referral recommendations. All participants will receive a comprehensive symptom report at the end of the trial. Referral resources will be provided again at that time if significant eating disorder symptoms remain. Treatment Conditions: Participants will be randomly assigned to 1 of 3 treatment conditions. Brochure Treatment Condition: Participants randomly assigned to the educational brochure will receive two educational brochures which discuss eating disorder symptoms. The brochures will also include treatment referral information and recommended resources for persons struggling with disordered eating. The brochure will take approximately 10 minutes to read; follow-up with treatment or self-help referral resources is completely voluntary. Group Therapy Treatment Conditions: Participants randomly assigned to one of the two group treatment intervention conditions will complete a 4-week group treatment program with 3-8 other women and 2 trained treatment co-facilitators. For approximately 1 hour each week, participants will meet in this group to complete a series of readings, written activities, and verbal activities designed to reduce disordered eating. During the 4 intervention sessions, participants will be asked to analyze the weight and appearance-related messages received from the media, peers, family, romantic partners, and other sources. Participants will also be asked to record, analyze, and evaluate weight and appearance-related thoughts, emotions, and behaviors. Participants will engage in a variety of exercises designed to evaluate the meaning of thinness in our culture and its personal impact. These exercises are designed to combat the detrimental impact of messages which promote thinness. Other risk factors will also be addressed, depending upon program. Participants may talk about the pressures women receive to focus on appearance. The relationship between these appearance-related pressures and eating disorder symptoms will be explored. Participants will explore the way they compare themselves to others and participate in a series of discussions and activities designed to decrease appearance-based comparisons with others. After the 4-week program is complete, participants in both intervention conditions will continue to work on homework assignments related to the program for a period of 2-months until the final assessment session.

Interventions

Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources.

BEHAVIORALBody Project Traditional

Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice & Shaw, 2001).

BEHAVIORALBody Project Expanded

Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017).

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Cornell College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized, controlled clinical trial with 3 treatment interventions

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 34 Years
Healthy volunteers
No

Inclusion criteria

* Inclusion Criteria * Women * Age 15-34 * Postmenarcheal * Premenopausal * Subclinical or Clinical Eating Disorder Symptoms

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Rosenberg Self-Esteem Scale (RSE).Baseline assessments occurred after screening and prior to the delivery of any interventions.The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.
Eating Disorder Examination Questionnaire (EDE-Q).Baseline assessments occurred after screening and prior to the delivery of any interventions.The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.
Body Shape Questionnaire (BSQ).Baseline assessments occurred after screening and prior to the delivery of any interventions.The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.
Social Comparison Rating Scale (SCRS).Baseline assessments occurred after screening and prior to the delivery of any interventions.The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.
Self-Objectification Questionnaire (SOQ)Baseline assessments occurred after screening and prior to the delivery of any interventions.The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.
State Trait Anxiety Inventory - Form Y.Baseline assessments occurred after screening and prior to the delivery of any interventions.The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.
Ideal Body Stereotype Scale - Revised.Baseline assessments occurred after screening and prior to the delivery of any interventions.The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.
Positive and Negative Affect Scale - Positive AffectBaseline assessments occurred after screening and prior to the delivery of any interventions.The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Mean R Wave AmplitudeBaseline assessments occurred after screening and prior to the delivery of any interventions.Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.
QT Interval LengthBaseline assessments occurred after screening and prior to the delivery of any interventions.QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.
Vagal Cardiac Tone - High Frequency Spectral PowerBaseline assessments occurred after screening and prior to the delivery of any interventions.High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.
Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power RatioBaseline assessments occurred after screening and prior to the delivery of any interventions.Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.
Positive and Negative Affect Scale - Negative AffectBaseline assessments occurred after screening and prior to the delivery of any interventions.The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.

Countries

United States

Participant flow

Recruitment details

Women aged 15-35 displaying subclinical and clinical eating disorder symptoms were recruited from 2 Midwestern cities and 5 surrounding suburban communities from November of 2018 to March of 2021. All participants were treated in accordance with federal guidelines (Title 45, Code of Regulations Part 46) for the treatment of human participants. The research was approved by an Institutional Review Board at the host institution.

Pre-assignment details

All participants were screened to ensure inclusion criteria were met. Inclusion criteria specified female participants ages 15-34 (postmenarcheal and premenopausal) who were not pregnant. Participant selection was limited to this group to control for the effects of estrogen on cardiac function and in accordance with previous research which suggests dissonance-based programs are most effective when offered solely to females over the age of 15.

Participants by arm

ArmCount
Educational Brochure
Participants will read an educational brochure from the National Eating Disorder Association and will receive referral resources. Educational Brochure: Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources.
49
Body Project Traditional
Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project group therapy program (Stice & Shaw, 2001). Body Project Traditional: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice & Shaw, 2001).
51
Body Project Expanded
Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project Expanded group therapy program (Green et al., 2017). Body Project Expanded: Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017).
50
Total150

Baseline characteristics

CharacteristicEducational BrochureBody Project TraditionalTotalBody Project Expanded
Age, Continuous22.48 years
STANDARD_DEVIATION 3.63
23.95 years
STANDARD_DEVIATION 5.73
22.75 years
STANDARD_DEVIATION 4.65
21.73 years
STANDARD_DEVIATION 4.08
Body Shape Questionnaire139.42 units on a scale
STANDARD_DEVIATION 23.92
134.37 units on a scale
STANDARD_DEVIATION 30.15
136.17 units on a scale
STANDARD_DEVIATION 27.55
134.73 units on a scale
STANDARD_DEVIATION 28.32
Eating Disorder Examination Questionnaire4.25 units on a scale
STANDARD_DEVIATION 0.8
3.93 units on a scale
STANDARD_DEVIATION 1.15
4.04 units on a scale
STANDARD_DEVIATION 1
3.96 units on a scale
STANDARD_DEVIATION 1.02
Ideal Body Stereotype Scale Revised3.81 units on a scale
STANDARD_DEVIATION 0.5
3.82 units on a scale
STANDARD_DEVIATION 0.45
3.79 units on a scale
STANDARD_DEVIATION 0.48
3.76 units on a scale
STANDARD_DEVIATION 0.5
Mean R Wave Amplitude1.27 mV
STANDARD_DEVIATION 0.36
1.19 mV
STANDARD_DEVIATION 0.31
1.23 mV
STANDARD_DEVIATION 0.35
1.24 mV
STANDARD_DEVIATION 0.37
Positive and Negative Affect Scale - Negative Affect30.15 units on a scale
STANDARD_DEVIATION 7.46
29.00 units on a scale
STANDARD_DEVIATION 6.88
29.59 units on a scale
STANDARD_DEVIATION 6.97
29.64 units on a scale
STANDARD_DEVIATION 6.6
Positive and Negative Affect Scale - Positive Affect26.35 units on a scale
STANDARD_DEVIATION 5.76
25.53 units on a scale
STANDARD_DEVIATION 7.1
25.71 units on a scale
STANDARD_DEVIATION 6.45
25.24 units on a scale
STANDARD_DEVIATION 6.46
QTc Prolongation.38 msec
STANDARD_DEVIATION 0.02
.38 msec
STANDARD_DEVIATION 0.02
.38 msec
STANDARD_DEVIATION 0.02
.38 msec
STANDARD_DEVIATION 0.02
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants2 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants3 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants10 Participants6 Participants
Race (NIH/OMB)
More than one race
4 Participants3 Participants8 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants5 Participants3 Participants
Race (NIH/OMB)
White
42 Participants42 Participants122 Participants38 Participants
Region of Enrollment
United States
49 Participants51 Participants150 Participants50 Participants
Rosenberg Self-Esteem Scale22.71 units on a scale
STANDARD_DEVIATION 4.71
22.50 units on a scale
STANDARD_DEVIATION 4.81
22.61 units on a scale
STANDARD_DEVIATION 4.53
22.62 units on a scale
STANDARD_DEVIATION 4.07
Self-Objectification Questionnaire10.13 units on a scale
STANDARD_DEVIATION 9.75
7.71 units on a scale
STANDARD_DEVIATION 13.11
8.07 units on a scale
STANDARD_DEVIATION 11.91
6.32 units on a scale
STANDARD_DEVIATION 12.46
Sex: Female, Male
Female
49 Participants51 Participants150 Participants50 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants
Social Comparison Rating Scale45.59 units on a scale
STANDARD_DEVIATION 17.1
43.83 units on a scale
STANDARD_DEVIATION 13.18
44.15 units on a scale
STANDARD_DEVIATION 14.75
43.00 units on a scale
STANDARD_DEVIATION 13.8
State Trait Anxiety Inventory Form Y58.87 units on a scale
STANDARD_DEVIATION 8.42
58.02 units on a scale
STANDARD_DEVIATION 7.84
58.52 units on a scale
STANDARD_DEVIATION 7.84
58.70 units on a scale
STANDARD_DEVIATION 7.9
Sympathetic Cardiac Tone - Low Frequency/High Frequency Spectral Power Ratio1.02 ratio: LF (watts/HZ) / HF (watts/Hz)
STANDARD_DEVIATION 1.55
.99 ratio: LF (watts/HZ) / HF (watts/Hz)
STANDARD_DEVIATION 0.84
.91 ratio: LF (watts/HZ) / HF (watts/Hz)
STANDARD_DEVIATION 1.18
.72 ratio: LF (watts/HZ) / HF (watts/Hz)
STANDARD_DEVIATION 0.53
Vagal Cardiac Tone - High Frequency Spectral Power60.08 Normalized units: HF (watts/Hz)
STANDARD_DEVIATION 19.56
57.26 Normalized units: HF (watts/Hz)
STANDARD_DEVIATION 19.78
58.51 Normalized units: HF (watts/Hz)
STANDARD_DEVIATION 16.9
61.61 Normalized units: HF (watts/Hz)
STANDARD_DEVIATION 5.87

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 600 / 60
other
Total, other adverse events
0 / 600 / 600 / 60
serious
Total, serious adverse events
1 / 600 / 602 / 60

Outcome results

Primary

Body Shape Questionnaire (BSQ).

The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureBody Shape Questionnaire (BSQ).139.42 units on a scaleStandard Deviation 23.92
Body Project TraditionalBody Shape Questionnaire (BSQ).134.37 units on a scaleStandard Deviation 30.15
Body Project ExpandedBody Shape Questionnaire (BSQ).134.73 units on a scaleStandard Deviation 28.32
Primary

Body Shape Questionnaire (BSQ).

The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureBody Shape Questionnaire (BSQ).137.65 units on a scaleStandard Deviation 20.91
Body Project TraditionalBody Shape Questionnaire (BSQ).110.96 units on a scaleStandard Deviation 33.39
Body Project ExpandedBody Shape Questionnaire (BSQ).114.50 units on a scaleStandard Deviation 30.96
Primary

Body Shape Questionnaire (BSQ).

The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureBody Shape Questionnaire (BSQ).129.51 units on a scaleStandard Deviation 23.74
Body Project TraditionalBody Shape Questionnaire (BSQ).105.19 units on a scaleStandard Deviation 32.23
Body Project ExpandedBody Shape Questionnaire (BSQ).105.29 units on a scaleStandard Deviation 28.28
Primary

Eating Disorder Examination Questionnaire (EDE-Q).

The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureEating Disorder Examination Questionnaire (EDE-Q).4.25 units on a scaleStandard Deviation 0.8
Body Project TraditionalEating Disorder Examination Questionnaire (EDE-Q).3.93 units on a scaleStandard Deviation 1.15
Body Project ExpandedEating Disorder Examination Questionnaire (EDE-Q).3.96 units on a scaleStandard Deviation 1.02
Primary

Eating Disorder Examination Questionnaire (EDE-Q).

The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureEating Disorder Examination Questionnaire (EDE-Q).4.17 units on a scaleStandard Deviation 0.64
Body Project TraditionalEating Disorder Examination Questionnaire (EDE-Q).2.93 units on a scaleStandard Deviation 1.2
Body Project ExpandedEating Disorder Examination Questionnaire (EDE-Q).3.07 units on a scaleStandard Deviation 1.23
Primary

Eating Disorder Examination Questionnaire (EDE-Q).

The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureEating Disorder Examination Questionnaire (EDE-Q).3.74 units on a scaleStandard Deviation 0.89
Body Project TraditionalEating Disorder Examination Questionnaire (EDE-Q).2.73 units on a scaleStandard Deviation 1.2
Body Project ExpandedEating Disorder Examination Questionnaire (EDE-Q).2.78 units on a scaleStandard Deviation 1.14
Primary

Ideal Body Stereotype Scale - Revised.

The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureIdeal Body Stereotype Scale - Revised.3.76 units on a scaleStandard Deviation 0.52
Body Project TraditionalIdeal Body Stereotype Scale - Revised.3.34 units on a scaleStandard Deviation 0.59
Body Project ExpandedIdeal Body Stereotype Scale - Revised.3.46 units on a scaleStandard Deviation 0.4
Primary

Ideal Body Stereotype Scale - Revised.

The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureIdeal Body Stereotype Scale - Revised.3.76 units on a scaleStandard Deviation 0.47
Body Project TraditionalIdeal Body Stereotype Scale - Revised.3.39 units on a scaleStandard Deviation 0.69
Body Project ExpandedIdeal Body Stereotype Scale - Revised.3.60 units on a scaleStandard Deviation 0.54
Primary

Ideal Body Stereotype Scale - Revised.

The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureIdeal Body Stereotype Scale - Revised.3.81 units on a scaleStandard Deviation 0.5
Body Project TraditionalIdeal Body Stereotype Scale - Revised.3.82 units on a scaleStandard Deviation 0.45
Body Project ExpandedIdeal Body Stereotype Scale - Revised.3.76 units on a scaleStandard Deviation 0.5
Primary

Mean R Wave Amplitude

Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureMean R Wave Amplitude1.27 millivolts (mV)Standard Deviation 0.36
Body Project TraditionalMean R Wave Amplitude1.19 millivolts (mV)Standard Deviation 0.31
Body Project ExpandedMean R Wave Amplitude1.27 millivolts (mV)Standard Deviation 0.36
Primary

Mean R Wave Amplitude

Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureMean R Wave Amplitude1.26 millivolts (mV)Standard Deviation 0.31
Body Project TraditionalMean R Wave Amplitude1.14 millivolts (mV)Standard Deviation 0.26
Body Project ExpandedMean R Wave Amplitude1.12 millivolts (mV)Standard Deviation 0.26
Primary

Mean R Wave Amplitude

Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureMean R Wave Amplitude1.32 millivolts (mV)Standard Deviation 0.32
Body Project TraditionalMean R Wave Amplitude1.19 millivolts (mV)Standard Deviation 0.24
Body Project ExpandedMean R Wave Amplitude1.27 millivolts (mV)Standard Deviation 0.36
Primary

Positive and Negative Affect Scale - Negative Affect

The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochurePositive and Negative Affect Scale - Negative Affect29.63 units on a scaleStandard Deviation 6.67
Body Project TraditionalPositive and Negative Affect Scale - Negative Affect25.61 units on a scaleStandard Deviation 6.99
Body Project ExpandedPositive and Negative Affect Scale - Negative Affect25.59 units on a scaleStandard Deviation 6.89
Primary

Positive and Negative Affect Scale - Negative Affect

The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochurePositive and Negative Affect Scale - Negative Affect28.50 units on a scaleStandard Deviation 7.96
Body Project TraditionalPositive and Negative Affect Scale - Negative Affect24.24 units on a scaleStandard Deviation 6.24
Body Project ExpandedPositive and Negative Affect Scale - Negative Affect25.00 units on a scaleStandard Deviation 5.82
Primary

Positive and Negative Affect Scale - Negative Affect

The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochurePositive and Negative Affect Scale - Negative Affect30.15 units on a scaleStandard Deviation 7.46
Body Project TraditionalPositive and Negative Affect Scale - Negative Affect29.00 units on a scaleStandard Deviation 6.88
Body Project ExpandedPositive and Negative Affect Scale - Negative Affect29.64 units on a scaleStandard Deviation 6.6
Primary

Positive and Negative Affect Scale - Positive Affect

The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochurePositive and Negative Affect Scale - Positive Affect26.35 units on a scaleStandard Deviation 5.76
Body Project TraditionalPositive and Negative Affect Scale - Positive Affect25.53 units on a scaleStandard Deviation 7.1
Body Project ExpandedPositive and Negative Affect Scale - Positive Affect25.24 units on a scaleStandard Deviation 6.46
Primary

Positive and Negative Affect Scale - Positive Affect

The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochurePositive and Negative Affect Scale - Positive Affect26.60 units on a scaleStandard Deviation 6.44
Body Project TraditionalPositive and Negative Affect Scale - Positive Affect27.84 units on a scaleStandard Deviation 5.85
Body Project ExpandedPositive and Negative Affect Scale - Positive Affect27.98 units on a scaleStandard Deviation 5.26
Primary

Positive and Negative Affect Scale - Positive Affect

The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochurePositive and Negative Affect Scale - Positive Affect25.54 units on a scaleStandard Deviation 6.36
Body Project TraditionalPositive and Negative Affect Scale - Positive Affect28.57 units on a scaleStandard Deviation 5.64
Body Project ExpandedPositive and Negative Affect Scale - Positive Affect27.82 units on a scaleStandard Deviation 6.69
Primary

QT Interval Length

QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureQT Interval Length.38 msecStandard Deviation 0.02
Body Project TraditionalQT Interval Length.38 msecStandard Deviation 0.02
Body Project ExpandedQT Interval Length.38 msecStandard Deviation 0.02
Primary

QT Interval Length

QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureQT Interval Length.38 msecStandard Deviation 0.02
Body Project TraditionalQT Interval Length.39 msecStandard Deviation 0.01
Body Project ExpandedQT Interval Length.39 msecStandard Deviation 0.01
Primary

QT Interval Length

Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureQT Interval Length.38 msecStandard Deviation 0.02
Body Project TraditionalQT Interval Length.38 msecStandard Deviation 0.01
Body Project ExpandedQT Interval Length.38 msecStandard Deviation 0.01
Primary

Rosenberg Self-Esteem Scale (RSE).

The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureRosenberg Self-Esteem Scale (RSE).22.71 units on a scaleStandard Deviation 4.71
Body Project TraditionalRosenberg Self-Esteem Scale (RSE).22.50 units on a scaleStandard Deviation 4.81
Body Project ExpandedRosenberg Self-Esteem Scale (RSE).22.62 units on a scaleStandard Deviation 4.07
Primary

Rosenberg Self-Esteem Scale (RSE).

The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureRosenberg Self-Esteem Scale (RSE).23.55 units on a scaleStandard Deviation 4.3
Body Project TraditionalRosenberg Self-Esteem Scale (RSE).25.45 units on a scaleStandard Deviation 4.5
Body Project ExpandedRosenberg Self-Esteem Scale (RSE).25.08 units on a scaleStandard Deviation 4.57
Primary

Rosenberg Self-Esteem Scale (RSE).

The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureRosenberg Self-Esteem Scale (RSE).24.55 units on a scaleStandard Deviation 4.74
Body Project TraditionalRosenberg Self-Esteem Scale (RSE).25.55 units on a scaleStandard Deviation 4.09
Body Project ExpandedRosenberg Self-Esteem Scale (RSE).26.60 units on a scaleStandard Deviation 4.48
Primary

Self-Objectification Questionnaire (SOQ)

The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureSelf-Objectification Questionnaire (SOQ)9.80 units on a scaleStandard Deviation 8.34
Body Project TraditionalSelf-Objectification Questionnaire (SOQ)2.81 units on a scaleStandard Deviation 12.39
Body Project ExpandedSelf-Objectification Questionnaire (SOQ)1.78 units on a scaleStandard Deviation 12.61
Primary

Self-Objectification Questionnaire (SOQ)

The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureSelf-Objectification Questionnaire (SOQ)10.40 units on a scaleStandard Deviation 9.08
Body Project TraditionalSelf-Objectification Questionnaire (SOQ)6.70 units on a scaleStandard Deviation 11.39
Body Project ExpandedSelf-Objectification Questionnaire (SOQ)2.35 units on a scaleStandard Deviation 13.65
Primary

Self-Objectification Questionnaire (SOQ)

The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureSelf-Objectification Questionnaire (SOQ)10.13 units on a scaleStandard Deviation 9.75
Body Project TraditionalSelf-Objectification Questionnaire (SOQ)7.71 units on a scaleStandard Deviation 13.11
Body Project ExpandedSelf-Objectification Questionnaire (SOQ)6.32 units on a scaleStandard Deviation 12.46
Primary

Social Comparison Rating Scale (SCRS).

The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureSocial Comparison Rating Scale (SCRS).45.59 units on a scaleStandard Deviation 17.1
Body Project TraditionalSocial Comparison Rating Scale (SCRS).43.83 units on a scaleStandard Deviation 13.18
Body Project ExpandedSocial Comparison Rating Scale (SCRS).43.00 units on a scaleStandard Deviation 13.8
Primary

Social Comparison Rating Scale (SCRS).

The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureSocial Comparison Rating Scale (SCRS).51.02 units on a scaleStandard Deviation 16.34
Body Project TraditionalSocial Comparison Rating Scale (SCRS).51.09 units on a scaleStandard Deviation 11.68
Body Project ExpandedSocial Comparison Rating Scale (SCRS).47.35 units on a scaleStandard Deviation 14.82
Primary

Social Comparison Rating Scale (SCRS).

The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureSocial Comparison Rating Scale (SCRS).46.28 units on a scaleStandard Deviation 17.39
Body Project TraditionalSocial Comparison Rating Scale (SCRS).53.39 units on a scaleStandard Deviation 10.93
Body Project ExpandedSocial Comparison Rating Scale (SCRS).53.18 units on a scaleStandard Deviation 15.88
Primary

State Trait Anxiety Inventory - Form Y.

The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureState Trait Anxiety Inventory - Form Y.55.63 units on a scaleStandard Deviation 9.45
Body Project TraditionalState Trait Anxiety Inventory - Form Y.51.63 units on a scaleStandard Deviation 7
Body Project ExpandedState Trait Anxiety Inventory - Form Y.52.58 units on a scaleStandard Deviation 9.71
Primary

State Trait Anxiety Inventory - Form Y.

The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureState Trait Anxiety Inventory - Form Y.57.15 units on a scaleStandard Deviation 7.39
Body Project TraditionalState Trait Anxiety Inventory - Form Y.53.05 units on a scaleStandard Deviation 8.22
Body Project ExpandedState Trait Anxiety Inventory - Form Y.54.63 units on a scaleStandard Deviation 9.31
Primary

State Trait Anxiety Inventory - Form Y.

The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureState Trait Anxiety Inventory - Form Y.58.87 units on a scaleStandard Deviation 8.42
Body Project TraditionalState Trait Anxiety Inventory - Form Y.58.02 units on a scaleStandard Deviation 7.84
Body Project ExpandedState Trait Anxiety Inventory - Form Y.58.70 units on a scaleStandard Deviation 7.9
Primary

Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio

Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureSympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio1.02 ratio: LF (watts/HZ) / HF (watts/Hz)Standard Deviation 1.55
Body Project TraditionalSympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio.99 ratio: LF (watts/HZ) / HF (watts/Hz)Standard Deviation 0.84
Body Project ExpandedSympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio.72 ratio: LF (watts/HZ) / HF (watts/Hz)Standard Deviation 0.53
Primary

Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio

Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureSympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio1.45 ratio: LF (watts/HZ) / HF (watts/Hz)Standard Deviation 3.51
Body Project TraditionalSympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio1.05 ratio: LF (watts/HZ) / HF (watts/Hz)Standard Deviation 1.17
Body Project ExpandedSympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio.85 ratio: LF (watts/HZ) / HF (watts/Hz)Standard Deviation 1.02
Primary

Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio

Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureSympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio1.54 ratio: LF (watts/HZ) / HF (watts/Hz)Standard Deviation 1.99
Body Project TraditionalSympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio1.86 ratio: LF (watts/HZ) / HF (watts/Hz)Standard Deviation 4.64
Body Project ExpandedSympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio1.32 ratio: LF (watts/HZ) / HF (watts/Hz)Standard Deviation 2.84
Primary

Vagal Cardiac Tone - High Frequency Spectral Power

High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.

Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureVagal Cardiac Tone - High Frequency Spectral Power51.65 Normalized units: HF (watts/Hz)Standard Deviation 20.56
Body Project TraditionalVagal Cardiac Tone - High Frequency Spectral Power56.60 Normalized units: HF (watts/Hz)Standard Deviation 22.83
Body Project ExpandedVagal Cardiac Tone - High Frequency Spectral Power58.81 Normalized units: HF (watts/Hz)Standard Deviation 19.68
Primary

Vagal Cardiac Tone - High Frequency Spectral Power

High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.

Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureVagal Cardiac Tone - High Frequency Spectral Power60.15 Normalized units: HF (watts/Hz)Standard Deviation 21.2
Body Project TraditionalVagal Cardiac Tone - High Frequency Spectral Power60.04 Normalized units: HF (watts/Hz)Standard Deviation 23.46
Body Project ExpandedVagal Cardiac Tone - High Frequency Spectral Power60.58 Normalized units: HF (watts/Hz)Standard Deviation 17.52
Primary

Vagal Cardiac Tone - High Frequency Spectral Power

High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.

Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.

Population: Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.

ArmMeasureValue (MEAN)Dispersion
Educational BrochureVagal Cardiac Tone - High Frequency Spectral Power60.08 Normalized units: HF (watts/Hz)Standard Deviation 19.56
Body Project TraditionalVagal Cardiac Tone - High Frequency Spectral Power57.26 Normalized units: HF (watts/Hz)Standard Deviation 19.78
Body Project ExpandedVagal Cardiac Tone - High Frequency Spectral Power61.61 Normalized units: HF (watts/Hz)Standard Deviation 5.87

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026