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Research Aimed at Improving Both Mood and Weight

NCT02246413 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2024-04-26

Study results available
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Summary

The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical and cost effectiveness and implementation potential of a primary care integrated multicondition intervention program to help improve mood and weight for obese adults with clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation added to the main trial with funding through the NIH common fund for the Science of Behavior Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial participants will be consented to undergo additional assays evaluating neurobiological mechanisms of self-regulation.

Conditions

Interventions

BEHAVIORAL

RAINBOW Intervention Program

Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Washington

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • University of Illinois at Chicago

    collaborator OTHER

  • Sutter Health

    collaborator OTHER

  • Palo Alto Medical Foundation

    lead OTHER

Principal Investigators

  • Jun Ma, MD, PhD · University of Illinois at Chicago

  • Leanne Williams, PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-01-17
Completion
2018-12-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246413 on ClinicalTrials.gov