CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 409 enrolled
Drug / intervention
RAINBOW Intervention Programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02246413
NCT02246413N/ACompleted
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RCT on Co-management of Obesity, Depression, and Elevated CVD Risk in Primary Care-- Engaging Self-regulation Targets to Understand the Mechanisms of Behavior Change and Improve Mood and Weight Outcomes

Palo Alto Medical Foundation·interventional·Posted Sep 22, 2014·Updated Apr 26, 2024

In Brief

A clinical study evaluating RAINBOW Intervention Program for Depression and Obesity. Completed, enrolled 409 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Obesity
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), University of Washington, University of Pittsburgh, Stanford University, University of Illinois at Chicago, Sutter Health

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 22, 2014
Enrollment StartSep 30, 2014
Primary CompletionJan 17, 2018
Study CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.8 years ago

Interventions

RAINBOW Intervention Programbehavioral

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