Clinical trial NCT05553925: Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0
Official title: Implementation of an Online Weight Management Program in Clinical and Community Settings
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-09-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will implement the combined intervention (online weight management program plus coaching and patient navigator support) as part of standard of care for at least 5,000 patients with overweight or obesity. All eligible patients, in each participating Brigham and Women's Hospital practice/site, who wish to enroll will receive the intervention. The investigators will invite a sample of enrolled patients to participate in a single-arm, longitudinal study to assess changes in patient-reported outcomes.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The investigators will recruit patients and providers from the following practices/sites affiliated with Brigham and Women's Hospital. Other sites may be included, if appropriate:

* BWH Primary Care Center of Excellence
* Division of Cardiovascular Medicine at BWH Heart \& Vascular Center
* BWH Division of Endocrinology, Diabetes, and Hypertension
* BWH Department of Orthopedic Surgery
* BWH Comprehensive Breast Health Center (only B-PREP program)
* BWH Center for Community Wellness at Sportsman's Tennis \& Enrichment Center
* BWH Center for Weight Management and Wellness
* BWH Nutrition and Wellness Service (within the Department of Nutrition)
* BWH Division of Sleep and Circadian Disorders

Pre- and Post-Implementation Focus Groups, Interviews, and Surveys:

The investigators will conduct focus groups and/or semi-structured interviews with approximately 15-20 patients, before and after implementing the intervention, to understand their attitudes and experiences with weight management and to obtain feedback on their thoughts about the proposed intervention. Patients will be eligible for the focus groups and interviews if they are receiving medical care at one of the participating BWH practices/sites, are over 20 years old, and have a BMI of 25 kg/m2 or higher. In addition, patients must speak English to participate in the focus groups and interviews.

The investigators will recruit 15-20 providers from the participating clinics for voluntary, semi-structured interviews and administer a survey to all providers in the clinics before and after implementing the intervention. Providers may include staff physicians, residents or fellows, nurse practitioners or physician assistants, and additional staff who provide services to patients, including dietitians and patient navigators. The goal will be to evaluate their views and practices around management of overweight and obesity, obtain feedback about the proposed intervention workflow, and identify any other barriers or facilitators to implementing the intervention. Providers will be eligible to participate if they practice in one of the participating BWH clinics.

Intervention Implementation:

The investigators will enroll at least 5,000 eligible patients from across the participating BWH practices/sites. The intervention will be offered as standard of care to all eligible patients at participating BWH practices/sites. Eligible patients will be enrolled in the program for 12 months. After patients register for the online program, they will complete lessons about nutrition, physical activity, sleep, and stress; track their diet, physical activity, and weight; and interact with a coach, who will provide personalized feedback and support. Patient navigators also will monitor patients' progress, periodically update providers, and help refer/connect them to other resources for weight management, if appropriate. The investigators will invite a sample of 300-500 patients who are enrolled in the intervention to complete an online survey at the beginning and end of their enrollment. The goal will be to assess changes in patient-reported outcomes, such as diet, physical activity, and health status.

Eligibility 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

Primary outcomes:
measure: Weight Change
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Reach
timeFrame: Every month for 14 months
measure: Patient Satisfaction
timeFrame: 12 months after enrollment in the program
measure: Diet
timeFrame: Baseline and 12 months
measure: Physical Activity
timeFrame: Baseline and 12 months
measure: Health Status
timeFrame: Baseline and 12 months
measure: Self-efficacy Around Weight Loss
timeFrame: Baseline and 12 months
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: Baseline and 12 months
measure: Changes in Blood Pressure
timeFrame: Baseline and 12 months
measure: Engagement with the Online Program
timeFrame: During 12 months of enrollment in the program
measure: Weight Change at 18 Months
timeFrame: 18 Months (six months after program completion)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Heather J Baer, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References: