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| ID | Type | Description | Link |
|---|---|---|---|
| CIHR PJT-153383 | Other Grant/Funding Number | Canadian Institutes of Health Research |
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The trial was ended prematurely due to low recruitment/enrolment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | 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. |
|
| ACT Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT Intervention | Behavioral |
| ||
| Standard Care |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | Weight change in kilograms | Baseline to Post-Intervention (on average, 16 weeks) |
| 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. | Baseline to Post-Intervention (on average, 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Fat Percentage Change | Change in body fat percentage | Baseline to Post-Intervention (on average, 16 weeks) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Administered Post-Intervention (at on average, 16 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mallory Frayn, PhD (c) | McGill University | Principal Investigator |
| Kimberly Carrière, PhD Student | McGill University | Study Director |
| Bärbel Knäuper, PhD | McGill University | Principal Investigator |
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Study data, including the intervention manual, study protocol, statistical analysis plan, and outcomes will be shared with other researchers upon request.
Upon publication of the study results.
Upon request from other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Change | Weight change in kilograms | Of those who initiated the intervention, 40 individuals completed all 8 sessions and had weight data at session 8. | Posted | Mean | 95% Confidence Interval | kilograms | Baseline to Post-Intervention (on average, 16 weeks) |
|
Adverse event data were collected over the duration which each participant was assessed, from Baseline to Post-Intervention (on average, 16 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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The intervention was terminated due to low recruitment, high attrition, and potential lack of treatment fidelity on the part of the intervening physicians.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mallory Frayn, PhD (c) | McGill University | 514-398-1399 | mallory.frayn@mail.mcgill.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2016 | Mar 21, 2019 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D005247 | Feeding Behavior |
| D000098382 | Emotional Eating |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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The present study was a two-arm pilot randomized controlled trial.
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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.
|
| Baseline to Post-Intervention (on average, 16 weeks) |
| 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. | Baseline to Post-Intervention (on average, 16 weeks) |
| 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. | Baseline to Post-Intervention (on average, 16 weeks) |
| 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. | Baseline to Post-Intervention (on average, 16 weeks) |
| 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. | Baseline to Post-Intervention (on average, 16 weeks) |
| 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. | Each physician was asked to complete this questionnaire once during their administration of the ACT intervention (from July 2016 to February 2017) |
| Recruitment Rates | Percentage of individuals who were eligible to participate in the study (based on the initial prescreen) that actually enrolled. | Prescreen questionnaire to Baseline |
| Number of Participants That Dropped Out From Study | Dropout rates between conditions from baseline to session 8. | Baseline to Post-Intervention (on average, 16 weeks) |
| Questionnaire Completion | Percentage of participants who completed questionnaires between conditions | Baseline to Post-Intervention (on average, 16 weeks) |
| Intervention Completion Time | How long it took participants in each condition to complete the 8-session intervention | Baseline to Post-Intervention (on average, 16 weeks) |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| DEBQ Emotional Eating | The emotional eating subscale of the Dutch Eating Behavior Questionnaire. 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. | Mean | Standard Deviation | units on a scale |
|
| DEBQ External Eating | The external eating subscale of the Dutch Eating Behavior Questionnaire. 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. | Mean | Standard Deviation | units on a scale |
|
| DEBQ Restraint Eating | The restraint eating subscale of the Dutch Eating Behavior Questionnaire. 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. | Mean | Standard Deviation | units on a scale |
|
| DTS Total Score | This is the total score of the Distress Tolerance Scale. 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. | Mean | Standard Deviation | units on a scale |
|
| PHLMS awareness | This is the awareness subscale of the Philadelphia Mindfulness Scale. 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. | Mean | Standard Deviation | units on a scale |
|
| PHLMS acceptance | This is the acceptance subscale of the Philadelphia Mindfulness Scale. 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 acceptance. | Mean | Standard Deviation | units on a scale |
|
| ACT assessment | 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 better application of the skills learned from the intervention. | Mean | Standard Deviation | units on a scale |
|
|
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Post-Intervention (on average, 16 weeks) |
|
|
|
| Secondary | Body Fat Percentage Change | Change in body fat percentage | Of those who initiated the intervention, 40 individuals completed all 8 sessions and had body fat data at session 8. | Posted | Mean | 95% Confidence Interval | percentage of body fat | Baseline to Post-Intervention (on average, 16 weeks) |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Post-Intervention (on average, 16 weeks) |
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|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Post-Intervention (on average, 16 weeks) |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Post-Intervention (on average, 16 weeks) |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Post-Intervention (on average, 16 weeks) |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Post-Intervention (on average, 16 weeks) |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Administered Post-Intervention (at on average, 16 weeks) |
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|
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Each physician was asked to complete this questionnaire once during their administration of the ACT intervention (from July 2016 to February 2017) |
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| Other Pre-specified | Recruitment Rates | Percentage of individuals who were eligible to participate in the study (based on the initial prescreen) that actually enrolled. | 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. | Posted | Count of Participants | Participants | Prescreen questionnaire to Baseline |
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| Other Pre-specified | Number of Participants That Dropped Out From Study | Dropout rates between conditions from baseline to session 8. | Posted | Count of Participants | Participants | Baseline to Post-Intervention (on average, 16 weeks) |
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| Other Pre-specified | Questionnaire Completion | Percentage of participants who completed questionnaires between conditions | Posted | Count of Participants | Participants | Baseline to Post-Intervention (on average, 16 weeks) |
|
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| Other Pre-specified | Intervention Completion Time | How long it took participants in each condition to complete the 8-session intervention | Posted | Mean | Standard Deviation | weeks | Baseline to Post-Intervention (on average, 16 weeks) |
|
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | 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 | 0 | 44 | 0 | 44 | 0 | 44 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |