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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501239
• Other study ID #: D15151
• Status: Completed
• Phase: N/A
• First received: July 14, 2015
• Last updated: April 24, 2018
• Start date: August 12, 2015
• Est. completion date: May 7, 2017

Study information

• Verified date: April 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 7, 2017
• Est. primary completion date: May 7, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Obesity
• Weight Loss

Intervention

Behavioral:
• Accept Yourself!

• Weight Watchers

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Hitchcock Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in fasting Lipids		At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
Secondary	Change in systolic and diastolic blood pressure		At post-treatment (immediately following the three-month intervention) and 12 month follow up
Secondary	Change in fasting blood glucose		At post-treatment (immediately following the three-month intervention) and 12 month follow up
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	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
Secondary	Change in self-reported physical activity		At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
Secondary	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.