Clinical trial

Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05553925

Active, not recruitingNot applicableInterventional

What this study is about

The primary objective of the project is to adapt and implement a combined weight management intervention (an online program plus coaching and patient navigator support) across multiple settings and a diverse cross-section of patients and providers affiliated with Brigham and Women's Hospital (BWH). The overall goals of the proposed project are: 1. To improve management of overweight and obesity in clinical and community settings. 2. To improve outcomes among patients with overweight or obesity. To accomplish these goals, the investigators will engage with various stakeholders to adapt the combined intervention, implement the intervention across multiple settings and a diverse cross-section of patients and providers affiliated with BWH, evaluate the impact of the implementation, and create an implementation guide for dissemination. The specific aims of the proposed project are as follows: Aim 1: To continue to engage with patients, providers, and other stakeholders to adapt and integrate the intervention in a variety of clinical and community settings. Aim 2: To implement the intervention in a variety of patients and settings and to evaluate its impact on outcomes, using the RE-AIM framework. Aim 3: To evaluate maintenance of the intervention six months after formal implementation activities have ended, and to prepare a detailed implementation guide to help increase future reach and uptake.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionOverweight, Obesity

Full registry criteria

Inclusion Criteria: 1. Age 20 years or over 2. Have a healthcare provider at BWH (received care from a primary care provider or specialist at BWH in last 24 months) 3. Have a primary care provider 4. BMI of 30 or over OR 5. BMI 25 to 29.9 kg/m2 plus ≥ 1 with indicators for increased cardiovascular risk or other obesity-related comorbidity (e.g., type 2 diabetes, prediabetes, high blood pressure, hyperlipidemia, sleep apnea, non-alcoholic fatty liver disease) 6. English- or Spanish-speaking 7. Regular Internet access (at least once per week) via smartphone, computer, or tablet and valid email address (required to register for the online program) Exclusion Criteria: 1. Patients who are pregnant 2. Patients who have Type 1 diabetes OR on insulin for treatment of diabetes 3. Patients receiving comfort care measures, hospice, or nursing home 4. Patients with a serious medical condition for which weight loss is contraindicated (e.g., end stage renal disease, active cancer (other than non-melanoma skin cancer) 5. Patients who have had bariatric or endoscopic surgery in last 12 months

Treatments and study arms

Online Weight Management Program with Coaching and Patient Navigator Support

Other

Patients will enroll in a 12-month digital health program available in online and mobile versions with live, personalized coaching and patient navigator support. Patient Interface * Digital scale and Fitbit * Brief lessons that focus on helping patients improve their nutrition, exercise, sleep, and stress * Weight, diet, and physical activity tracking * Regular, personalized feedback and support from a health coach * Spanish Version Patient navigators are non-licensed staff. Their responsibilities will include enrolling patients in the program, monitoring their progress, and updating providers periodically. They also will be able to connect patients with additional resources and services, such as the Center for Weight Management and Wellness, if appropriate.

Primary outcomes

Weight ChangeBaseline and 12 months

Weight change over 12 months, calculated from patients' weights recorded from digital scales, manually entered in the online program, and/or recorded in the electronic health record at visits. These weights will be used to calculate weight change over 12 months among enrolled patients and the number/proportion of enrolled patients who achieve ≥ 5% weight loss over 12 months.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

Open map