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

NCT05553925 | Active Not Recruiting DMC

• 1 other identifier: 2022P000605
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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. 1.To improve management of overweight and obesity in clinical and community settings.
2. 2.To improve outcomes among patients with overweight or obesity.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Weight Change

  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.

  Baseline and 12 months

Secondary Outcomes (10)

• Reach

  Every month for 14 months

• Patient Satisfaction

  12 months after enrollment in the program

• Diet

  Baseline and 12 months

• Physical Activity

  Baseline and 12 months

• Health Status

  Baseline and 12 months

Study Arms (1)

Intervention Implementation

EXPERIMENTAL

At least 5,000 patients from the participating BWH practices/sites will receive the combined intervention (online weight management program with patient navigator support and personalized coaching) as part of standard of care for overweight and obesity.

Other: Online Weight Management Program with Coaching and Patient Navigator Support

Interventions

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.

Intervention Implementation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 years or over
• Have a healthcare provider at BWH (received care from a primary care provider or specialist at BWH in last 24 months)
• Have a primary care provider
• BMI of 30 or over OR
• 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)
• English- or Spanish-speaking
• Regular Internet access (at least once per week) via smartphone, computer, or tablet and valid email address (required to register for the online program)

You may not qualify if:

• Patients who are pregnant
• Patients who have Type 1 diabetes OR on insulin for treatment of diabetes
• Patients receiving comfort care measures, hospice, or nursing home
• 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)
• Patients who have had bariatric or endoscopic surgery in last 12 months

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Heather J Baer, Sc.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: September 26, 2022
• Study Start: November 3, 2022
• Primary Completion: February 28, 2025
• Study Completion: August 28, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)