Integrating Online Weight Management With Primary Care Support

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.

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.

11. 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