Adolescent Obesity
Conditions
Brief summary
The purpose of the study is to determine whether a novel model of including parents in adolescent weight control results in greater decrease in adolescent z-BMI compared to an intervention with minimal parent involvement.
Interventions
BEHAVIORALBehavioral Weight Control with Enhanced Parent Involvement
BEHAVIORALBehavioral Weight Control with Minimal Parent Involvement
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Between 30 and 90% overweight * Parent or guardian willing to participate
Exclusion criteria
* Major psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Baseline and at completion of 16 week intervention | Post-treatment BMI (controlling for baseline BMI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Modeling 2: Self-monitoring (WCSS) | Baseline to post-treatment | Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome. |
| Parent Modeling 3: Physical Activity (WCSS) | Baseline to post-treatment | Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome. |
| Parent Modeling 1: Dietary Choices (WCSS) | Baseline to post-treatment | Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome. |
| Communication 1: Negative Maternal Weight-related Commentary (FERF-Q) | Baseline to post-treatment | Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome. |
| Communication 2: Observed Parent-adolescent Communication Quality (DOCS) | Baseline to post-treatment | Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome. |
| Parent Modeling 4: Weight and Body Concerns (FERF-Q) | Baseline to post-treatment | Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Weight Control With Enhanced Parent Involvement This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement | 23 |
| Behavioral Weight Control With Minimal Parent Involvement This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement | 26 |
| Total | 49 |
Baseline characteristics
| Characteristic | Behavioral Weight Control With Enhanced Parent Involvement | Behavioral Weight Control With Minimal Parent Involvement | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 26 Participants | 49 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.21 years STANDARD_DEVIATION 1.4 | 15.00 years STANDARD_DEVIATION 1.3 | 15.10 years STANDARD_DEVIATION 1.33 |
| Body Mass Index (kg/m^2) | 33.25 kilograms/meters squared (kg/m2) STANDARD_DEVIATION 4.02 | 31.17 kilograms/meters squared (kg/m2) STANDARD_DEVIATION 3.01 | 32.16 kilograms/meters squared (kg/m2) STANDARD_DEVIATION 3.64 |
| Communication 1: Negative weight-related comments | 2.73 units on a scale STANDARD_DEVIATION 0.73 | 2.85 units on a scale STANDARD_DEVIATION 0.64 | 2.79 units on a scale STANDARD_DEVIATION 0.7 |
| Communication 2: Observed parent-adolescent communication quality | 5.5 units on a scale STANDARD_DEVIATION 2.1 | 5.8 units on a scale STANDARD_DEVIATION 1.9 | 5.7 units on a scale STANDARD_DEVIATION 1.9 |
| Parent modeling 1: Dietary Choices (WCSS) | 2.70 units on a scale STANDARD_DEVIATION 0.76 | 2.32 units on a scale STANDARD_DEVIATION 1.13 | 2.50 units on a scale STANDARD_DEVIATION 0.98 |
| Parent modeling 2: Self-monitoring (WCSS) | .81 units on a scale STANDARD_DEVIATION 0.8 | 0.55 units on a scale STANDARD_DEVIATION 0.7 | 0.67 units on a scale STANDARD_DEVIATION 0.75 |
| Parent modeling 3: Physical Activity (WCSS) | 1.75 units on a scale STANDARD_DEVIATION 1.17 | 0.90 units on a scale STANDARD_DEVIATION 1.05 | 1.30 units on a scale STANDARD_DEVIATION 1.18 |
| Parent modeling 4: Weight and Body Concerns | 2.75 units on a scale STANDARD_DEVIATION 0.8 | 2.90 units on a scale STANDARD_DEVIATION 0.89 | 2.83 units on a scale STANDARD_DEVIATION 0.84 |
| Region of Enrollment United States | 23 participants | 26 participants | 49 participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 23 |
| serious Total, serious adverse events | 0 / 26 | 0 / 23 |
Outcome results
Primary
Body Mass Index
Post-treatment BMI (controlling for baseline BMI)
Time frame: Baseline and at completion of 16 week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Control With Minimal Parent Involvement | Body Mass Index | 29.89 kilograms/meters squared | Standard Deviation 3.41 |
| Behavioral Weight Control With Enhanced Parent Involvement | Body Mass Index | 32.82 kilograms/meters squared | Standard Deviation 4.06 |
Comparison: Null hypothesis was that the amount of weight lost by adolescents in Enhanced Parent Involvement and Minimal Parent involvement would not be significantly different. The study was powered at .8 to achieve a medium effect size (f = .26; partial eta sq. = 0.06).~The end-of-treatment BMI value was the dependent variable, with the baseline BMI value entered as a covariate.p-value: 0.06ANCOVA
Secondary
Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)
Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome.
Time frame: Baseline to post-treatment
Population: Secondary outcomes analyzed for treatment completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Control With Minimal Parent Involvement | Communication 1: Negative Maternal Weight-related Commentary (FERF-Q) | 2.71 units on a scale | Standard Deviation 0.8 |
| Behavioral Weight Control With Enhanced Parent Involvement | Communication 1: Negative Maternal Weight-related Commentary (FERF-Q) | 2.32 units on a scale | Standard Deviation 0.7 |
p-value: 0.01ANCOVA
Secondary
Communication 2: Observed Parent-adolescent Communication Quality (DOCS)
Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome.
Time frame: Baseline to post-treatment
Population: 38 participants (19 in each group) had complete baseline and post treatment data for videotaped observations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Control With Minimal Parent Involvement | Communication 2: Observed Parent-adolescent Communication Quality (DOCS) | 5.5 units on a scale | Standard Deviation 1.9 |
| Behavioral Weight Control With Enhanced Parent Involvement | Communication 2: Observed Parent-adolescent Communication Quality (DOCS) | 5.8 units on a scale | Standard Deviation 1.8 |
p-value: 0.61ANCOVA
Secondary
Parent Modeling 1: Dietary Choices (WCSS)
Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome.
Time frame: Baseline to post-treatment
Population: Secondary outcomes analyzed for treatment completers only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Control With Minimal Parent Involvement | Parent Modeling 1: Dietary Choices (WCSS) | 2.92 units on a scale | Standard Deviation 0.82 |
| Behavioral Weight Control With Enhanced Parent Involvement | Parent Modeling 1: Dietary Choices (WCSS) | 2.87 units on a scale | Standard Deviation 0.5 |
Comparison: The end-of-treatment value was the dependent variable, with the baseline value entered as a covariate.p-value: 0.58ANCOVA
Secondary
Parent Modeling 2: Self-monitoring (WCSS)
Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome.
Time frame: Baseline to post-treatment
Population: Secondary outcomes analyzed for treatment completers only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Control With Minimal Parent Involvement | Parent Modeling 2: Self-monitoring (WCSS) | 0.81 units on a scale | Standard Deviation 0.81 |
| Behavioral Weight Control With Enhanced Parent Involvement | Parent Modeling 2: Self-monitoring (WCSS) | 1.28 units on a scale | Standard Deviation 0.67 |
p-value: 0.19ANCOVA
Secondary
Parent Modeling 3: Physical Activity (WCSS)
Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome.
Time frame: Baseline to post-treatment
Population: Secondary outcomes analyzed for treatment completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Control With Minimal Parent Involvement | Parent Modeling 3: Physical Activity (WCSS) | 1.9 units on a scale | Standard Deviation 1 |
| Behavioral Weight Control With Enhanced Parent Involvement | Parent Modeling 3: Physical Activity (WCSS) | 1.32 units on a scale | Standard Deviation 0.75 |
p-value: 0.72ANCOVA
Secondary
Parent Modeling 4: Weight and Body Concerns (FERF-Q)
Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome.
Time frame: Baseline to post-treatment
Population: Secondary outcomes analyzed for treatment completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Control With Minimal Parent Involvement | Parent Modeling 4: Weight and Body Concerns (FERF-Q) | 2.63 units on a scale | Standard Deviation 1.02 |
| Behavioral Weight Control With Enhanced Parent Involvement | Parent Modeling 4: Weight and Body Concerns (FERF-Q) | 2.64 units on a scale | Standard Deviation 0.88 |
p-value: 0.41ANCOVA