Integrating Online Weight Management With Primary Care Support

Completed · Not applicable

Conditions studied: Obesity

In brief

The goal of this project is to adapt an evidence-based online weight management program and integrate it with population management support from primary care practices. Investigators then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1) the combined intervention (online weight management program plus population management support) with 2) the stand-alone online weight management program and with 3) usual care, among overweight and obese primary care patients with type 2 diabetes or hypertension. The specific aims are: 1. a. To adapt an online weight management program and integrate it with population management support, incorporating input from patients, primary care clinicians, and other stakeholders; afterward, investigators will acquire feedback on the positive and negative aspects of the intervention. b. To compare the effectiveness of the combined intervention (online weight management program plus population management support) with the stand-alone online program and with usual care. Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months compared with the stand-alone online program and with usual care. 2. To identify mediators of the combined intervention and the stand-alone online program. Hypothesis 2: The effects of the combined intervention and the stand-alone online program on weight loss will be mediated by patients' level of engagement, changes in self-efficacy, and changes in diet and physical activity. 3. To explore whether the effectiveness of the combined intervention and the stand-alone weight management program varies by patient characteristics. Hypothesis 3: The interventions will be more effective among patients who are younger, white, and higher socioeconomic status, although the population management strategy may help to reduce these differences.

Key facts

Study ID

NCT02656693

Run by

Brigham and Women's Hospital

People needed

840

Starts

2016-07-19

Expected to finish

2019-05-08

Last updated by the study team

2020-11-05

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• upcoming or recent visit at primary care practice affiliated with Brigham and Women's Hospital
• age 20-70
• diagnosis of type 2 diabetes and/or hypertension
• BMI >= 27 and < 40 kg/m2
• motivated to lose weight
• valid email address and access the Internet using a computer, tablet, or smartphone
• English or Spanish-speaking

You may not qualify if…

• on insulin for treatment of their diabetes 2. MI, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in last 6 months 3. Unstable angina 4. Currently pregnant or planning to become pregnant during the study period 5. Currently lactating 5. Has had bariatric surgery or planning to have bariatric surgery 6. >5% weight loss in the last 6 months 7. Severe psychiatric illness or impaired mental status 8. Active or diagnosed history of and/or self-reported history of eating disorders 9. Self-reported average consumption of > 14 alcoholic drinks/week 10. Any serious medical condition that would affect weight loss or for which weight loss is contraindicated, including active cancer (excluding non-melanoma skin cancer) or currently being treated for cancer, end stage renal disease (ESRD) on dialysis, etc.
• On comfort care measures, hospice, or in nursing home 12. Participating in a contra-indicative research study 13. Use of prescription or over-the-counter weight loss medications or an all-liquid diet program in the last 6 months or currently 14. Any other medical contraindication for weight loss or physical activity, or any other reason that the PCP or their delegate (e.g., LPN or RN) did not deem the patient appropriate for the study

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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