Integrating Online Weight Management With Primary Care Support (PROPS)

Mass General Brigham

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Population health management support; Behavioral: Online weight management program

Study type: Interventional

Funder types: Other

Identifiers

NCT02656693

2015P002372

Details and patient eligibility

About

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.

Full description

Focus Groups and Key Informant Interviews:

Focus groups will be conducted with 5 to 7 patients at the beginning of the study to obtain their feedback about an online program and the population health management support strategy. To be eligible for the focus groups, patients must have a Brigham and Women's Hospital (BWH) primary care clinician, be between ages 20-70 years old, and have a recent BMI (in the past year) between approximately 27 and 40 kg/m2. They should also be interested in weight management and/or motivated to lose weight.

Phone interviews will be conducted at the end of the study to solicit feedback on the BMIQ program and the population health management intervention. Patients in the PROPS Study who are assigned to the online program or combined intervention arm, reach the 18-month timepoint, and complete the final study survey are eligible and will be invited to participate.

Key Informant Interviews will be conducted at the beginning and the end of the study. To be eligible, the key informants must be clinicians or other staff who provide services to patients at one of the participating BWH primary care practices. There are a total of 165 clinicians in these practices, including staff physicians, residents or fellows, and nurse practitioners or physician assistants. Approximately 7 clinicians at each timepoint will be recruited as key informants and will also be asked to complete electronic surveys during the trial.

After adapting the online weight management program and integrating it with the population management support strategy based on our focus groups and key informant interviews, investigators will conduct a three-arm cluster-randomized trial to compare the effectiveness of the combined intervention (online weight management program plus population management support) with the stand-alone online weight management program and with usual care. This will be a pragmatic clinical trial conducted in approximately 14 BWH primary care practices. To be eligible for the trial, patients must have an upcoming scheduled visit at a BWH primary care practice, BMI between 27 and 39.9 kg/m2 at enrollment, and a diagnosis of type 2 diabetes or hypertension. They also must be between ages 20 and 70 (inclusive) at enrollment, speak English or Spanish, and have access the Internet using a computer, tablet, or smart phone. Finally, patients must be motivated to lose weight. Investigators plan to recruit a total of 840 patients for the study (280 per arm). Patients who enroll in the trial will attend regular primary care visits at their practices and also will complete surveys by e-mail, regular mail, or phone.

Enrollment: 840 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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.

2. 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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840 participants in 3 patient groups

Online Program Only

Experimental group

Description:

Patients will use an online weight management program called BMIQ, with minimal additional support.

Treatment:

Behavioral: Online weight management program

Combined Intervention

Experimental group

Description:

Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices.

Treatment:

Behavioral: Population health management support

Behavioral: Online weight management program

Usual Care

No Intervention group

Description:

Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)