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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

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Eating Behavior Behavioral: ACT Intervention Behavioral: Standard Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The present study was a two-arm pilot randomized controlled trial.
Masking: Single (Participant)
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.
Primary Purpose: Treatment
Official Title: An ACT-Based Physician-Delivered Weight Loss Intervention
Actual Study Start Date : May 7, 2016
Actual Primary Completion Date : March 7, 2018
Actual Study Completion Date : March 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Standard Care
Experimental: 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.
Behavioral: ACT Intervention
Behavioral: Standard Care



Primary Outcome Measures :
  1. Weight Change [ Time Frame: Baseline to Post-Intervention (on average, 16 weeks) ]
    Weight change in kilograms

  2. Emotional Eating Change [ Time Frame: 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 Outcome Measures :
  1. Body Fat Percentage Change [ Time Frame: Baseline to Post-Intervention (on average, 16 weeks) ]
    Change in body fat percentage

  2. External Eating Change [ Time Frame: 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.

  3. Restraint Eating Change [ Time Frame: 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.

  4. Distress Tolerance Change [ Time Frame: 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.

  5. Mindfulness Awareness Change [ Time Frame: 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.

  6. Values Clarification/ACT Application Change [ Time Frame: 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.


Other Outcome Measures:
  1. Patient Treatment Satisfaction [ Time Frame: 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.

  2. Physician Treatment Satisfaction [ Time Frame: 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.

  3. Recruitment Rates [ Time Frame: Prescreen questionnaire to Baseline ]
    Percentage of individuals who were eligible to participate in the study (based on the initial prescreen) that actually enrolled.

  4. Number of Participants That Dropped Out From Study [ Time Frame: Baseline to Post-Intervention (on average, 16 weeks) ]
    Dropout rates between conditions from baseline to session 8.

  5. Questionnaire Completion [ Time Frame: Baseline to Post-Intervention (on average, 16 weeks) ]
    Percentage of participants who completed questionnaires between conditions

  6. Intervention Completion Time [ Time Frame: Baseline to Post-Intervention (on average, 16 weeks) ]
    How long it took participants in each condition to complete the 8-session intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611829


Sponsors and Collaborators
McGill University
Investigators
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Principal Investigator: Mallory Frayn, PhD (c) McGill University
Study Director: Kimberly Carrière, PhD Student McGill University
Principal Investigator: Bärbel Knäuper, PhD McGill University
  Study Documents (Full-Text)

Documents provided by McGill University:

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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 Posted: August 2, 2018    Key Record Dates
Results First Posted: August 14, 2019
Last Update Posted: August 14, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study data, including the intervention manual, study protocol, statistical analysis plan, and outcomes will be shared with other researchers upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Upon publication of the study results.
Access Criteria: Upon request from other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McGill University:
emotional eating
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes