Eating Behavior, Overweight and Obesity
Conditions
Keywords
emotional eating
Brief summary
The purpose of the present study was to conduct a pilot RCT to test the feasibility of a physician-delivered ACT-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. Participants were randomized to receive either standard care at the clinics or the ACT intervention.
Detailed description
The purpose of the present study was to conduct a pilot RCT to test the feasibility of a physician-delivered ACT-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. Psychology clinical PhD students trained physicians in the delivery of the brief manualized intervention and were available for regular consults. The intervention consisted of eight, 5-10 minute sessions that could be easily incorporated into the physician's current practice. Over the duration of the ACT intervention, physicians met individually with patients to teach them various techniques to address and improve mindfulness, acceptance, and values clarification and commitment, all of which emotional eaters have been found to struggle with (Forman & Butryn, 2014). The proven habit formation technique of if-then planning (Gollwitzer, 1993) was used throughout these sessions in order to train emotional eaters to habitually use ACT techniques and to change the maladaptive habit of eating in response to negative emotions.
Interventions
BEHAVIORALACT Intervention
BEHAVIORALStandard Care
Sponsors
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants were blind to their condition, but physicians and administrative staff were not blind to participant condition. Physicians were not blind to participant condition because they were responsible for delivering the ACT intervention or standard care. They were thus required to know the participant's condition in order to deliver the adequate treatment. Administrative staff was responsible for providing physicians with this information and organizing study paperwork and thus needed to be aware of participant condition as well.
Intervention model description
The present study was a two-arm pilot randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Only participants considered to be emotional eaters, as assessed by a score of 3.25 or higher on the Dutch Eating Behavior Questionnaire (DEBQ), were recruited for the study (van Strien, Herman, Anschutz, Engels, & de Weerth, 2012).
Exclusion criteria
* Not being an emotional eater. * Participants who did not speak, write, and read in English fluently were excluded from the study, as well as those who were pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | Baseline to Post-Intervention (on average, 16 weeks) | Weight change in kilograms |
| Emotional Eating Change | Baseline to Post-Intervention (on average, 16 weeks) | Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) emotional eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower emotional eating. This subscale score is calculated by taking the mean of all items on the subscale. Negative change scores reflect decreases in emotional eating. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Values Clarification/ACT Application Change | Baseline to Post-Intervention (on average, 16 weeks) | This questionnaire was developed for the present study to evaluate participants' real world application of the intervention. Participants were asked to indicate their level of agreement on a 5-point scale (1 = strongly agree and 5 = strongly disagree) to prompts such as My values motivate me to lose weight and I am able to accept negative emotions and don't have to eat when I'm feeling bad. Total score was calculated as the mean of all items. Lower scores indicate higher values clarification. Negative change scores reflect increases in ACT application and values clarification. |
| Body Fat Percentage Change | Baseline to Post-Intervention (on average, 16 weeks) | Change in body fat percentage |
| External Eating Change | Baseline to Post-Intervention (on average, 16 weeks) | Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) external eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower external eating. This subscale score is calculated by taking the mean of all items on the subscale. Negative change scores reflect decreases in external eating. |
| Restraint Eating Change | Baseline to Post-Intervention (on average, 16 weeks) | Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) restraint eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower restraint eating. This subscale score is calculated by taking the mean of all items on the subscale. Positive change scores reflect increase in restraint eating. |
| Distress Tolerance Change | Baseline to Post-Intervention (on average, 16 weeks) | Assessed by the Distress Tolerance Scale (DTS). All items were rated on a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). The score is calculated as the mean of all items. Higher scores reflect higher levels of distress tolerance. Positive change scores reflect increases in distress tolerance. |
| Mindfulness Awareness Change | Baseline to Post-Intervention (on average, 16 weeks) | Assessed by the Philadelphia Mindfulness Scale (PHLMS). All items were rated on a 5-point Likert scale from 1 (never) to 5 (very often). The subscale score is calculated as the sum of all items on the subscale, with the minimum possible score being 10 and the maximum possible score being 50. Higher scores reflect higher levels of awareness. Negative change scores reflect decreases in mindfulness and positive change scores reflect increases in mindfulness. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Treatment Satisfaction | Administered Post-Intervention (at on average, 16 weeks) | Assessed by a self-developed questionnaire with items such as the program reduced my emotional eating and the program was easy to follow. Scores represent mean ratings on a 5-point Likert-type rating scale from 1 (strongly agree) to 5 (strongly disagree). Lower scores reflect higher treatment satisfaction. |
| Physician Treatment Satisfaction | Each physician was asked to complete this questionnaire once during their administration of the ACT intervention (from July 2016 to February 2017) | Assessed by a self-developed questionnaire with items such as ease of difficulty and required preparation time. The following questions were assessed on Likert scales from 1 (to little) to 5 (too much) with middle scores (3) reflecting perceived balance (e.g., not too difficult, the right amount of preparation time). Total score was calculated as the mean of all items. |
| Recruitment Rates | Prescreen questionnaire to Baseline | Percentage of individuals who were eligible to participate in the study (based on the initial prescreen) that actually enrolled. |
| Number of Participants That Dropped Out From Study | Baseline to Post-Intervention (on average, 16 weeks) | Dropout rates between conditions from baseline to session 8. |
| Questionnaire Completion | Baseline to Post-Intervention (on average, 16 weeks) | Percentage of participants who completed questionnaires between conditions |
| Intervention Completion Time | Baseline to Post-Intervention (on average, 16 weeks) | How long it took participants in each condition to complete the 8-session intervention |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Participants in the standard care condition were provided with diet and exercise counselling and psychoeducation from their physicians over the course of 8 sessions, as was routinely done at the clinic. Standard care did not involve any targeted intervention to reduce emotional eating.
Standard Care | 43 |
| ACT Intervention In addition to receiving standard care, participants in the ACT condition were taught techniques to reduce their emotional eating. Three overarching skills were taught over the course of the ACT intervention: (1) values clarification and commitment, (2) metacognitive awareness, and (3) distress tolerance. Throughout the sessions, physicians formed if-then plans with the patients to specify how to habitually use the ACT techniques to reduce emotional eating in their everyday lives. At the end of each session, participants were given a one-page homework sheet that asked them to monitor their behavior and their use of the ACT techniques during the week.
ACT Intervention
Standard Care | 44 |
| Total | 87 |
Baseline characteristics
| Characteristic | Total | ACT Intervention | Standard Care |
|---|---|---|---|
| ACT assessment | 2.91 units on a scale STANDARD_DEVIATION 0.71 | 2.90 units on a scale STANDARD_DEVIATION 0.7 | 2.92 units on a scale STANDARD_DEVIATION 0.73 |
| Age, Continuous | 46.91 years STANDARD_DEVIATION 14.56 | 46.94 years STANDARD_DEVIATION 14.21 | 46.87 years STANDARD_DEVIATION 15.18 |
| DEBQ Emotional Eating | 4.02 units on a scale STANDARD_DEVIATION 0.51 | 3.96 units on a scale STANDARD_DEVIATION 0.49 | 4.09 units on a scale STANDARD_DEVIATION 0.53 |
| DEBQ External Eating | 3.56 units on a scale STANDARD_DEVIATION 0.6 | 3.56 units on a scale STANDARD_DEVIATION 0.56 | 3.57 units on a scale STANDARD_DEVIATION 0.65 |
| DEBQ Restraint Eating | 3.17 units on a scale STANDARD_DEVIATION 0.66 | 3.17 units on a scale STANDARD_DEVIATION 0.69 | 3.18 units on a scale STANDARD_DEVIATION 0.64 |
| DTS Total Score | 2.59 units on a scale STANDARD_DEVIATION 0.89 | 2.69 units on a scale STANDARD_DEVIATION 0.84 | 2.48 units on a scale STANDARD_DEVIATION 0.94 |
| PHLMS acceptance | 25.50 units on a scale STANDARD_DEVIATION 7.34 | 26.00 units on a scale STANDARD_DEVIATION 7 | 24.94 units on a scale STANDARD_DEVIATION 7.79 |
| PHLMS awareness | 36.04 units on a scale STANDARD_DEVIATION 6.38 | 36.06 units on a scale STANDARD_DEVIATION 6.78 | 36.03 units on a scale STANDARD_DEVIATION 6.02 |
| Race/Ethnicity, Customized Caucasian | 39 Participants | 24 Participants | 15 Participants |
| Region of Enrollment Canada | 87 participants | 44 participants | 43 participants |
| Sex: Female, Male Female | 61 Participants | 31 Participants | 30 Participants |
| Sex: Female, Male Male | 26 Participants | 13 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 44 |
| other Total, other adverse events | 0 / 43 | 0 / 44 |
| serious Total, serious adverse events | 0 / 43 | 0 / 44 |
Outcome results
Primary
Emotional Eating Change
Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) emotional eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower emotional eating. This subscale score is calculated by taking the mean of all items on the subscale. Negative change scores reflect decreases in emotional eating.
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Population: Of those who initiated the intervention, only 26 participants completed the DEBQ at baseline and post-intervention (session 8) to be included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Emotional Eating Change | -0.92 units on a scale |
| ACT Intervention | Emotional Eating Change | -0.91 units on a scale |
Primary
Weight Change
Weight change in kilograms
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Population: Of those who initiated the intervention, 40 individuals completed all 8 sessions and had weight data at session 8.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Weight Change | 1.56 kilograms |
| ACT Intervention | Weight Change | 0.71 kilograms |
Secondary
Body Fat Percentage Change
Change in body fat percentage
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Population: Of those who initiated the intervention, 40 individuals completed all 8 sessions and had body fat data at session 8.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Body Fat Percentage Change | -0.72 percentage of body fat |
| ACT Intervention | Body Fat Percentage Change | 0.16 percentage of body fat |
Secondary
Distress Tolerance Change
Assessed by the Distress Tolerance Scale (DTS). All items were rated on a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). The score is calculated as the mean of all items. Higher scores reflect higher levels of distress tolerance. Positive change scores reflect increases in distress tolerance.
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Population: Of those who initiated the intervention, only 26 participants completed the DTS at baseline and post-intervention (session 8) to be included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Distress Tolerance Change | 0.52 units on a scale |
| ACT Intervention | Distress Tolerance Change | 0.04 units on a scale |
Secondary
External Eating Change
Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) external eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower external eating. This subscale score is calculated by taking the mean of all items on the subscale. Negative change scores reflect decreases in external eating.
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Population: Of those who initiated the intervention, only 26 participants completed the DEBQ at baseline and post-intervention (session 8) to be included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | External Eating Change | -0.52 units on a scale |
| ACT Intervention | External Eating Change | -0.31 units on a scale |
Secondary
Mindfulness Awareness Change
Assessed by the Philadelphia Mindfulness Scale (PHLMS). All items were rated on a 5-point Likert scale from 1 (never) to 5 (very often). The subscale score is calculated as the sum of all items on the subscale, with the minimum possible score being 10 and the maximum possible score being 50. Higher scores reflect higher levels of awareness. Negative change scores reflect decreases in mindfulness and positive change scores reflect increases in mindfulness.
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Population: Of those who initiated the intervention, only 26 participants completed the PHLMS at baseline and post-intervention (session 8) to be included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Mindfulness Awareness Change | -1.50 units on a scale |
| ACT Intervention | Mindfulness Awareness Change | 1.67 units on a scale |
Secondary
Restraint Eating Change
Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) restraint eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower restraint eating. This subscale score is calculated by taking the mean of all items on the subscale. Positive change scores reflect increase in restraint eating.
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Population: Of those who initiated the intervention, only 26 participants completed the DEBQ at baseline and post-intervention (session 8) to be included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Restraint Eating Change | 0.27 units on a scale |
| ACT Intervention | Restraint Eating Change | 0.26 units on a scale |
Secondary
Values Clarification/ACT Application Change
This questionnaire was developed for the present study to evaluate participants' real world application of the intervention. Participants were asked to indicate their level of agreement on a 5-point scale (1 = strongly agree and 5 = strongly disagree) to prompts such as My values motivate me to lose weight and I am able to accept negative emotions and don't have to eat when I'm feeling bad. Total score was calculated as the mean of all items. Lower scores indicate higher values clarification. Negative change scores reflect increases in ACT application and values clarification.
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Population: Of those who initiated the intervention, only 26 participants completed the ACT application at baseline and post-intervention (session 8) to be included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Values Clarification/ACT Application Change | -0.60 units on a scale |
| ACT Intervention | Values Clarification/ACT Application Change | -0.43 units on a scale |
Other Pre-specified
Intervention Completion Time
How long it took participants in each condition to complete the 8-session intervention
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Intervention Completion Time | 15.41 weeks | Standard Deviation 10.97 |
| ACT Intervention | Intervention Completion Time | 17.41 weeks | Standard Deviation 12.39 |
Other Pre-specified
Number of Participants That Dropped Out From Study
Dropout rates between conditions from baseline to session 8.
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants That Dropped Out From Study | 22 Participants |
| ACT Intervention | Number of Participants That Dropped Out From Study | 25 Participants |
Other Pre-specified
Patient Treatment Satisfaction
Assessed by a self-developed questionnaire with items such as the program reduced my emotional eating and the program was easy to follow. Scores represent mean ratings on a 5-point Likert-type rating scale from 1 (strongly agree) to 5 (strongly disagree). Lower scores reflect higher treatment satisfaction.
Time frame: Administered Post-Intervention (at on average, 16 weeks)
Population: Of those who initiated the intervention, only 28 participants completed the treatment satisfaction questionnaire at post-intervention (session 8) to be included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Patient Treatment Satisfaction | 1.95 units on a scale | Standard Deviation 0.8 |
| ACT Intervention | Patient Treatment Satisfaction | 2.03 units on a scale | Standard Deviation 0.77 |
Other Pre-specified
Physician Treatment Satisfaction
Assessed by a self-developed questionnaire with items such as ease of difficulty and required preparation time. The following questions were assessed on Likert scales from 1 (to little) to 5 (too much) with middle scores (3) reflecting perceived balance (e.g., not too difficult, the right amount of preparation time). Total score was calculated as the mean of all items.
Time frame: Each physician was asked to complete this questionnaire once during their administration of the ACT intervention (from July 2016 to February 2017)
Population: Physicians who delivered the ACT intervention were asked to provide their input on the intervention. They only completed this questionnaire in relation to the ACT intervention and not standard care.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Physician Treatment Satisfaction | 3.51 units on a scale | Standard Deviation 0.76 |
Other Pre-specified
Questionnaire Completion
Percentage of participants who completed questionnaires between conditions
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Questionnaire Completion | 15 Participants |
| ACT Intervention | Questionnaire Completion | 13 Participants |
Other Pre-specified
Recruitment Rates
Percentage of individuals who were eligible to participate in the study (based on the initial prescreen) that actually enrolled.
Time frame: Prescreen questionnaire to Baseline
Population: 123 of those who completed the initial prescreen questionnaire were deemed eligible for the study and randomized to standard care (64) or ACT intervention (59). Of these, 43 and 44 participants, respectively actually began the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Recruitment Rates | 43 Participants |
| ACT Intervention | Recruitment Rates | 44 Participants |