An ACT-Based Physician-Delivered Weight Loss 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. Participants were randomized to receive either standard care at the clinics or the ACT intervention.

Study Overview

• Status: Terminated
• Conditions: Overweight and Obesity; Eating Behavior
• Intervention / Treatment: Behavioral: Standard Care; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Standard Care; Behavioral: ACT Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Other Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Study Director: Kimberly Carrière, PhD Student, McGill University

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2016
• Primary Completion (Actual): March 7, 2018
• Study Completion (Actual): March 7, 2018

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: emotional eating
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 405-0316; CIHR PJT-153383 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No