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An ACT-Based Physician-Delivered Weight Loss Intervention

Primary Purpose

Overweight and Obesity, Eating Behavior

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACT Intervention
Standard Care
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring emotional eating

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard Care

    ACT Intervention

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Weight Change
    Weight change in kilograms
    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.

    Secondary Outcome Measures

    Body Fat Percentage Change
    Change in body fat percentage
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    June 18, 2018
    Last Updated
    July 3, 2019
    Sponsor
    McGill University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03611829
    Brief Title
    An ACT-Based Physician-Delivered Weight Loss Intervention
    Official Title
    An ACT-Based Physician-Delivered Weight Loss Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    The trial was ended prematurely due to low recruitment/enrolment.
    Study Start Date
    May 7, 2016 (Actual)
    Primary Completion Date
    March 7, 2018 (Actual)
    Study Completion Date
    March 7, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McGill University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity, Eating Behavior
    Keywords
    emotional eating

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The present study was a two-arm pilot randomized controlled trial.
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    87 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Care
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    ACT Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ACT Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Care
    Primary Outcome Measure Information:
    Title
    Weight Change
    Description
    Weight change in kilograms
    Time Frame
    Baseline to Post-Intervention (on average, 16 weeks)
    Title
    Emotional Eating Change
    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)
    Secondary Outcome Measure Information:
    Title
    Body Fat Percentage Change
    Description
    Change in body fat percentage
    Time Frame
    Baseline to Post-Intervention (on average, 16 weeks)
    Title
    External Eating Change
    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)
    Title
    Restraint Eating Change
    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)
    Title
    Distress Tolerance Change
    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)
    Title
    Mindfulness Awareness Change
    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)
    Title
    Values Clarification/ACT Application Change
    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)
    Other Pre-specified Outcome Measures:
    Title
    Patient Treatment Satisfaction
    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)
    Title
    Physician Treatment Satisfaction
    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)
    Title
    Recruitment Rates
    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
    Title
    Number of Participants That Dropped Out From Study
    Description
    Dropout rates between conditions from baseline to session 8.
    Time Frame
    Baseline to Post-Intervention (on average, 16 weeks)
    Title
    Questionnaire Completion
    Description
    Percentage of participants who completed questionnaires between conditions
    Time Frame
    Baseline to Post-Intervention (on average, 16 weeks)
    Title
    Intervention Completion Time
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mallory Frayn, PhD (c)
    Organizational Affiliation
    McGill University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kimberly Carrière, PhD Student
    Organizational Affiliation
    McGill University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Bärbel Knäuper, PhD
    Organizational Affiliation
    McGill University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Study data, including the intervention manual, study protocol, statistical analysis plan, and outcomes will be shared with other researchers upon request.
    IPD Sharing Time Frame
    Upon publication of the study results.
    IPD Sharing Access Criteria
    Upon request from other researchers.

    Learn more about this trial

    An ACT-Based Physician-Delivered Weight Loss Intervention

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