Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women

Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women: A Randomized Controlled Trial

The primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined Health At Every Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself! compared to a commercial behavioral weight loss program, Weight Watchers (WW). Obese women (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two treatments. Depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.

Study Overview

• Status: Completed
• Conditions: Depression; Obesity
• Intervention / Treatment: Behavioral: Accept Yourself!; Behavioral: Weight Watchers

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• English-speaking
• Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV)
• Body Mass Index (BMI) greater than or equal to 30
• Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study)

Exclusion Criteria:

• current substance dependence
• history of psychotic symptoms
• high risk of suicide/self-harm
• current enrollment in a weight-loss program
• weight loss surgery in the past year
• current psychotherapy
• inability to postpone weight loss or depression treatment interventions for the duration of the study
• taking antipsychotic, tricyclic, or oral corticosteroid medication
• unwilling to be randomized to the study treatments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accept Yourself! Intervention; Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group	Behavioral: Accept Yourself!; Other Names: HAES/ACT
Active Comparator: Behavioral Weight Loss; Weight Watchers groups	Behavioral: Weight Watchers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinician assessed depression symptoms	As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)	At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
Change in self-reported depression symptoms	As assessed by Patient Health Questionnaire-9 (PHQ-9)	At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting Lipids		At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
Change in systolic and diastolic blood pressure		At post-treatment (immediately following the three-month intervention) and 12 month follow up
Change in fasting blood glucose		At post-treatment (immediately following the three-month intervention) and 12 month follow up
Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)		At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)		At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)		At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)		At post-treatment (immediately following the three-month intervention)
Change in weight	Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group).	At post-treatment (immediately following the three-month intervention) and 12 month follow up
Change in self-reported physical activity		At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
Change in cardiovascular fitness as assessed by six-minute walk test		At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Hitchcock Foundation
• Investigators: Principal Investigator: Margit I Berman, Ph.D, Dartmouth College

Publications and helpful links

General Publications

• Berman MI, Park J, Kragenbrink ME, Hegel MT. Accept Yourself! A Pilot Randomized Controlled Trial of a Self-Acceptance-Based Treatment for Large-Bodied Women With Depression. Behav Ther. 2022 Sep;53(5):913-926. doi: 10.1016/j.beth.2022.03.002. Epub 2022 Mar 23.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2015
• Primary Completion (Actual): May 7, 2017
• Study Completion (Actual): May 7, 2017

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Depression; Depressive Disorder; Obesity; Weight Loss
• Other Study ID Numbers: D15151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No