An ACT-Based Physician-Delivered Weight Loss Intervention

NCT03611829 | Terminated Results

• 2 other identifiers: 405-0316CIHR PJT-153383
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity; Eating Behavior

Keywords

emotional eating

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Body Fat Percentage Change

  Baseline to Post-Intervention (on average, 16 weeks)

• External Eating Change

  Baseline to Post-Intervention (on average, 16 weeks)

• Restraint Eating Change

  Baseline to Post-Intervention (on average, 16 weeks)

• Distress Tolerance Change

  Baseline to Post-Intervention (on average, 16 weeks)

• Mindfulness Awareness Change

  Baseline to Post-Intervention (on average, 16 weeks)

Other Outcomes (6)

• Patient Treatment Satisfaction

  Administered Post-Intervention (at on average, 16 weeks)

• Physician Treatment Satisfaction

  Each physician was asked to complete this questionnaire once during their administration of the ACT intervention (from July 2016 to February 2017)

• Recruitment Rates

  Prescreen questionnaire to Baseline

Study Arms (2)

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.

Behavioral: Standard Care

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.

Behavioral: ACT Intervention; Behavioral: Standard Care

Interventions

ACT Intervention BEHAVIORAL

ACT Intervention

Standard Care BEHAVIORAL

ACT Intervention; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

MeSH Terms

Conditions

Overweight; Obesity; Feeding Behavior; Emotional Eating

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The intervention was terminated due to low recruitment, high attrition, and potential lack of treatment fidelity on the part of the intervening physicians.

Results Point of Contact

• Title: Mallory Frayn, PhD (c)
• Organization: McGill University

mallory.frayn@mail.mcgill.ca

514-398-1399

Study Officials

• Mallory Frayn, PhD (c)

  McGill University

  PRINCIPAL INVESTIGATOR

• Kimberly Carrière, PhD Student

  McGill University

  STUDY DIRECTOR

• Bärbel Knäuper, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The present study was a two-arm pilot randomized controlled trial.

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: August 2, 2018
• Study Start: May 7, 2016
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication of the study results.
• Access Criteria: Upon request from other researchers.