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An ACT-Based Physician-Delivered Weight Loss Intervention

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ClinicalTrials.gov Identifier: NCT03611829
Recruitment Status : Terminated (The trial was ended prematurely due to low recruitment/enrolment.)
First Posted : August 2, 2018
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
McGill University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Overweight and Obesity
Eating Behavior
Interventions Behavioral: ACT Intervention
Behavioral: Standard Care
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Care ACT Intervention
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 43 44
Completed 21 19
Not Completed 22 25
Arm/Group Title Standard Care ACT Intervention Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 43 44 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 44 participants 87 participants
46.87  (15.18) 46.94  (14.21) 46.91  (14.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 44 participants 87 participants
Female
30
  69.8%
31
  70.5%
61
  70.1%
Male
13
  30.2%
13
  29.5%
26
  29.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 43 participants 44 participants 87 participants
15
  34.9%
24
  54.5%
39
  44.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 43 participants 44 participants 87 participants
43 44 87
DEBQ Emotional Eating   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 43 participants 44 participants 87 participants
4.09  (0.53) 3.96  (0.49) 4.02  (0.51)
[1]
Measure Description: 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.
DEBQ External Eating   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 43 participants 44 participants 87 participants
3.57  (0.65) 3.56  (0.56) 3.56  (0.60)
[1]
Measure Description: 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.
DEBQ Restraint Eating   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 43 participants 44 participants 87 participants
3.18  (0.64) 3.17  (0.69) 3.17  (0.66)
[1]
Measure Description: 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.
DTS Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 43 participants 44 participants 87 participants
2.48  (0.94) 2.69  (0.84) 2.59  (0.89)
[1]
Measure Description: 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.
PHLMS awareness   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 43 participants 44 participants 87 participants
36.03  (6.02) 36.06  (6.78) 36.04  (6.38)
[1]
Measure Description: 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.
PHLMS acceptance   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 43 participants 44 participants 87 participants
24.94  (7.79) 26.00  (7.00) 25.50  (7.34)
[1]
Measure Description: 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.
ACT assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 43 participants 44 participants 87 participants
2.92  (0.73) 2.90  (0.70) 2.91  (0.71)
[1]
Measure Description: 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.
1.Primary Outcome
Title Weight Change
Hide Description Weight change in kilograms
Time Frame Baseline to Post-Intervention (on average, 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Of those who initiated the intervention, 40 individuals completed all 8 sessions and had weight data at session 8.
Arm/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21 19
Mean (95% Confidence Interval)
Unit of Measure: kilograms
1.56
(-7.49 to 10.62)
0.71
(-2.32 to 3.76)
2.Primary Outcome
Title Emotional Eating Change
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 13 13
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.92
(-1.35 to -0.49)
-0.91
(-1.47 to -0.35)
3.Secondary Outcome
Title Body Fat Percentage Change
Hide Description Change in body fat percentage
Time Frame Baseline to Post-Intervention (on average, 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Of those who initiated the intervention, 40 individuals completed all 8 sessions and had body fat data at session 8.
Arm/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21 19
Mean (95% Confidence Interval)
Unit of Measure: percentage of body fat
-0.72
(-1.53 to 0.09)
0.16
(-0.92 to 1.23)
4.Secondary Outcome
Title External Eating Change
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 13 13
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.52
(-0.98 to -0.06)
-0.31
(-0.78 to 0.16)
5.Secondary Outcome
Title Restraint Eating Change
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 13 13
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.27
(-0.01 to 0.55)
0.26
(-0.16 to 0.68)
6.Secondary Outcome
Title Distress Tolerance Change
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 13 13
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.52
(0.18 to 0.86)
0.04
(-0.31 to 0.39)
7.Secondary Outcome
Title Mindfulness Awareness Change
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 13 13
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.50
(-4.51 to 1.51)
1.67
(-1.76 to 5.10)
8.Secondary Outcome
Title Values Clarification/ACT Application Change
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 13 13
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.60
(-1.15 to -0.04)
-0.43
(-1.06 to 0.20)
9.Other Pre-specified Outcome
Title Patient Treatment Satisfaction
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 15 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.95  (0.80) 2.03  (0.77)
10.Other Pre-specified Outcome
Title Physician Treatment Satisfaction
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ACT Intervention
Hide Arm/Group Description:
Physician treatment satisfaction for the ACT intervention.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.51  (0.76)
11.Other Pre-specified Outcome
Title Recruitment Rates
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 64 59
Measure Type: Count of Participants
Unit of Measure: Participants
43
  67.2%
44
  74.6%
12.Other Pre-specified Outcome
Title Number of Participants That Dropped Out From Study
Hide Description Dropout rates between conditions from baseline to session 8.
Time Frame Baseline to Post-Intervention (on average, 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 43 44
Measure Type: Count of Participants
Unit of Measure: Participants
22
  51.2%
25
  56.8%
13.Other Pre-specified Outcome
Title Questionnaire Completion
Hide Description Percentage of participants who completed questionnaires between conditions
Time Frame Baseline to Post-Intervention (on average, 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 43 44
Measure Type: Count of Participants
Unit of Measure: Participants
15
  34.9%
13
  29.5%
14.Other Pre-specified Outcome
Title Intervention Completion Time
Hide Description How long it took participants in each condition to complete the 8-session intervention
Time Frame Baseline to Post-Intervention (on average, 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care ACT Intervention
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: weeks
15.41  (10.97) 17.41  (12.39)
Time Frame Adverse event data were collected over the duration which each participant was assessed, from Baseline to Post-Intervention (on average, 16 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Care ACT Intervention
Hide Arm/Group Description

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

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

All-Cause Mortality
Standard Care ACT Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/44 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Care ACT Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/44 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Care ACT Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/44 (0.00%) 
The intervention was terminated due to low recruitment, high attrition, and potential lack of treatment fidelity on the part of the intervening physicians.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mallory Frayn, PhD (c)
Organization: McGill University
Phone: 514-398-1399
EMail: mallory.frayn@mail.mcgill.ca
Layout table for additonal information
Responsible Party: McGill University
ClinicalTrials.gov Identifier: NCT03611829     History of Changes
Other Study ID Numbers: 405-0316
CIHR PJT-153383 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Submitted: June 18, 2018
First Posted: August 2, 2018
Results First Submitted: December 3, 2018
Results First Posted: August 14, 2019
Last Update Posted: August 14, 2019