Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women

NCT00572520 | Completed DMC

• 2 other identifiers: R01MH078012DAHBR 96-BHB
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effectiveness of two weight loss programs, one supplemented with health education and the other supplemented with behavioral counseling, in treating women who are depressed and overweight.

Conditions

Depression; Obesity

Keywords

Depressive Disorder; Weight Loss; Behavioral Treatment; Behavior Therapy; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Change in body weight and the trend in body weight over time

  Measured at Month 6 and Years 1 and 2

Secondary Outcomes (2)

• Change in depression, physical activity, diet (daily caloric intake), psychosocial variables (anhedonia, exercise self-efficacy, disinhibited eating, quality of life), and cardiovascular risk factors (blood pressure, serum lipids, C-reactive protein)

  Measured at Year 2

• Effect of potential mediators (adherence, depression, general and physical activity, caloric intake) on weight change

  Measured at Year 2

Study Arms (2)

1

ACTIVE COMPARATOR

Evidence-based behavioral weight loss treatment with health education counseling

Behavioral: Weight loss treatment; Behavioral: Health education counseling

2

EXPERIMENTAL

Evidence-based behavioral weight loss treatment with brief behavior therapy for depression

Behavioral: Weight loss treatment; Behavioral: Behavior therapy for depression

Interventions

Weight loss treatment BEHAVIORAL

Over 2 years, this treatment involves a total of 26 group visits and 10 individual visits with a health education counselor. Group visits, led by a registered dietitian and a licensed exercise physiologist, will target diet and physical activity.

1; 2

Behavior therapy for depression BEHAVIORAL

Behavior therapy for depression will be delivered by a trained behavior therapist. Participants receiving behavioral counseling will learn about depression, links between activity and mood, and will be asked to keep a diary of moods and activities.

2

Health education counseling BEHAVIORAL

Health education counseling will be delivered by a trained health education counselor. Participants receiving health education will learn about women's health topics and receive tips on staying healthy and preventing disease.

1

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-IV criteria for major depressive disorder
• Score of 12 to 24 on Hamilton Depression Rating Scale (HDRS)
• Body mass index (BMI) of 30 to 40 kg

You may not qualify if:

• Plans to move out of the area during the study
• Current smoker
• Diagnosis of bipolar disorder, a psychotic disorder, bulimia, or post-traumatic stress disorder
• Meets criteria for severe depression (HDRS score greater than 24)
• Diagnosis of type 1 or 2 diabetes
• Plans to have bariatric surgery during the study
• No access to a telephone
• Unable to walk unaided or unable to walk 1/4 mile without stopping
• Does not have written clearance from primary care physician for physical activity
• Presence of a condition that precludes dietary changes (e.g., ulcerative colitis, Crohn's disease, active diverticulitis, renal disease)
• Presence of medical conditions likely to limit lifespan
• Taking prescription weight loss medications
• Initiation of anti-depressant medication within the 3 months prior to study entry
• Taking mood stabilizers, antipsychotic medication, or medications known to affect appetite and/or weight (e.g., corticosteroids)
• Reports active suicidal ideation via SCID interview, a score of 3 on item 24 of the HDRS (active suicidal ideation), or determined to have suicidal potential by clinical staff

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• Schneider KL, Bodenlos JS, Ma Y, Olendzki B, Oleski J, Merriam P, Crawford S, Ockene IS, Pagoto SL. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder. BMC Psychiatry. 2008 Sep 15;8:77. doi: 10.1186/1471-244X-8-77.

  PMID: 18793398 DERIVED

MeSH Terms

Conditions

Depression; Obesity; Depressive Disorder; Weight Loss

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mood Disorders; Mental Disorders; Body Weight Changes

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sherry L. Pagoto, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 5, 2018

Record last verified: 2018-07

Locations

US (1)