Randomized Control Trial on Comanagement of Obesity, Depression, and Elevated CVD Risk in Primary Care (RAINBOW)

Abstract

Patients with coexisting obesity and depression and common cardiometabolic risk factors are a critical target group for primary prevention because of their increasing prevalence and increased, but potentially reversible, lifetime risk for diabete mellitus (DM) and cardiovascular disease. But little is known about how to treat them in concert in ways that are evidence-based and practical in primary care settings.

This study tests, for the first time, a clinical intervention that uniquely integrates the Group Lifestyle Balance (GLB) Program for weight loss, which is a "real-world" translated model of the Diabetes Prevention Program lifestyle intervention, with the PEARLS collaborative stepped care program for depression, which uses problem-solving therapy (PST) as first-line with as-needed intensification through stepwise increases in doses and number of antidepressant medications.

Obese, depressed adults with coexisting metabolic syndrome, pre- DM, and/or history of gestational DM will be the target patient population. Eligible and consenting primary care patients (n=404) from a large, community-based, multispecialty group practice will be randomized to receive the combined treatment or usual care for 12 months.

Trained health coaches, working under co-located psychiatric and medical supervision, will provide 8 1-on-1 PST sessions over 5 months followed by 6 monthly calls. At the 4th 1-on-1 session, the coach will introduce the take-home GLB DVD, which has 12 weekly sessions and is supplemented by ongoing Web-, mobile- and email-mediated coach support for weight loss and behavior change. Following a stepped-care protocol, the supervising psychiatrist will recommend initiating or adjusting anti- depressant medications to primary providers of patients with unremitting symptoms, and if necessary, provide phone consultations to patients. Follow-up assessments will occur at 6, 12, 18, and 24 months.

The primary aim is to determine the effectiveness of the intervention ("E" in the RE-AIM model). We hypothesize that

  1. Compared with controls, intervention participants will have better co-primary endpoints, i.e., lower mean BMI and score on the 20-item Depression Symptom Checklist at 12 months (end of treatment)
  2. These incremental intervention benefits will persist through 24 months (end of follow-up)
  3. The intervention will show cost-effectiveness within 2 years and over a projected longer term, based on the ratio of incremental costs (estimated from health system and societal perspectives) to incremental benefits (expressed as quality-adjusted life years gained).

The secondary aim is to conduct process evaluation with mixed methods for the other RE-AIM attributes: Reach (e.g., participation rate of the target population), Adoption (e.g., characteristcs of participating clinics and providers), Implementation (e.g., fidelity of intervention delivery), and Maintenance (e.g., stakeholders' perceptions of intervention sustainability).

We will also explore effect modifiers and mediators to enable intervention refinement for maximum impact. The proposed integrated multicondition approach to treating obesity and depression and cardiometabolic risk factors in primary care is novel and likely scalable, with high public health impact potential.

Affiliated Center/Program

Principal investigator
Funding Agency

National Heart, Lung and Blood Institute of the National Institutes of Health (Grant No. R01HL119453)

 

Learn more about this study on the clinicaltrials.gov website.

 

Direct Costs for Year 5:

$573,460

Start date
05/01/2014
End date
03/31/2019

Related publications


See publications supported by this grant on this PubMed list.

Ma J, Rosas LG, Lv N, Xiao L, Snowden MB, Venditti EM, Lewis MA, Goldhaber-Fiebert JD, Lavori PW. Effect of Integrated Behavioral Weight Loss Treatment and Problem-Solving Therapy on Body Mass Index and Depressive Symptoms Among Patients With Obesity and Depression: The RAINBOW Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):869-879. doi: 10.1001/jama.2019.0557.

Ma J, Rosas LG, Lv N. Precision Lifestyle Medicine: A New Frontier in the Science of Behavior Change and Population Health. Am J Prev Med. 2016 Mar;50(3):395-397. [PMCID: www.ncbi.nlm.nih.gov/pmc/articles/PMC4762748/]

Ma J, Yank V, Lv N, Goldhaber-Fiebert JD, Lewis MA, Kramer MK, Snowden MB, Rosas LG, Xiao L, Blonstein AC. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial. Contemp Clin Trials. 2015 Jul;43:260-78. [See abstract.]