NCT00169273

Brief Summary

We propose to:

  • Conduct cross-sectional assessments of depression, disability, health-related quality of life, eating patterns, and eating attitudes in a population-based sample approximately 6000 women aged 40-60 with over-sampling of women with BMI greater than 30 kg/m2.
  • Among obese women free of depression, enroll approximately 100 in a 6-month standard behavior therapy weight management program.
  • Among obese women with significant depression, randomly assign 200 to either a 6-month standard behavior therapy weight management program or a combined cognitive-behavior therapy program focused on both depression and weight management.
  • Complete follow up assessments of weight, depressive symptoms, and functional status in all three treatment groups for 12 months following enrollment Screening and follow-up data will be used to address the following questions:
  • Association between depression and obesity among middle-aged women
  • Specific effects of depression and obesity on functional status, disability, and health services utilization
  • Impact of depression on participation in and outcomes of a standardized weight management program
  • Benefit of combined treatment (focused on depression and weight management) above that of standardized behavioral therapy for obese women with significant depressive symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2004

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

September 12, 2005

Last Update Submit

October 11, 2017

Conditions

ObesityDepression

Keywords

ObesityDepressionBehavioralCognitiveTreatment

Outcome Measures

Primary Outcomes (2)

  • Weight loss since baseline

    24 months

  • Mean SCL depression score

    24 months

Secondary Outcomes (3)

  • Estimated caloric intake

    24 months

  • Physical activity

    24 months

  • Self-efficacy

    24 months

Study Arms (2)

Weight loss only intervention

ACTIVE COMPARATOR

Structured group weight loss intervention

Behavioral: Structured behavioral weight loss group

Combined intervention

EXPERIMENTAL

Structured group program for weight loss and depression

Behavioral: Weight loss and cognitive-behavioral depression group

Interventions

Structured behavioral weight loss groupBEHAVIORAL

Structured group weight loss program

Weight loss only intervention
Weight loss and cognitive-behavioral depression groupBEHAVIORAL

Structured group program for weight loss and depression

Combined intervention

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 to 65
  • Body Mass Index \>= 30
  • Clinically significant depression
  • PHQ score of 10 or more
  • Current or past major depressive episode
  • Current symptoms include depressed mood or loss of interest
  • Enrolled in Group Health Cooperative health plan

You may not qualify if:

  • History of treatment for bipolar disorder or schizophrenia
  • Not willing to participate in group intervention
  • Medical contra-indications to graded exercise program
  • Unable to walk for 10 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Linde JA, Simon GE, Ludman EJ, Ichikawa LE, Operskalski BH, Arterburn D, Rohde P, Finch EA, Jeffery RW. A randomized controlled trial of behavioral weight loss treatment versus combined weight loss/depression treatment among women with comorbid obesity and depression. Ann Behav Med. 2011 Feb;41(1):119-30. doi: 10.1007/s12160-010-9232-2.

    PMID: 20878292DERIVED

MeSH Terms

Conditions

ObesityDepressionBehavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral Symptoms

Study Officials

  • Gregory E Simon, MD MPH

    Group Health Research Institute

    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

September 12, 2005

First Posted

September 15, 2005

Study Start

April 1, 2004

Primary Completion

February 1, 2007

Study Completion

April 1, 2007

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)