Online Weight Management Program for Obesity

(PROPS2 Trial)

Overseen By Richard Fay

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Insulin

Disqualifiers: Pregnancy, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Online Weight Management Program with Coaching and Patient Navigator Support for obesity?

Research shows that internet-based weight management programs, like the Healthy Weight Coaching (HWC), which include personal coaching and focus on diet, physical activity, and psychological factors, can be effective for managing obesity. These programs allow participants to track their progress and have regular online discussions with coaches, which can help with weight loss over a 12-month period. ^{1 2 3 4 5}

Is the Online Weight Management Program for Obesity safe for humans?

The research does not provide specific safety data for the Online Weight Management Program for Obesity, but similar web-based weight loss programs have been implemented without reported safety concerns. ^{2 5 6 7 8}

How is the Online Weight Management Program with Coaching and Patient Navigator Support different from other obesity treatments?

This treatment is unique because it combines a long-term, web-based program with personal coaching and patient navigator support, focusing on diet, physical activity, psychological factors, and sleep. Unlike many other online programs, it offers a comprehensive, year-long intervention with regular online discussions with a personal coach, making it more personalized and supportive. ^{2 9 10 11 12}

Research Team

Heather J Baer, Sc.D.

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults over 20 who have a healthcare provider at Brigham and Women's Hospital, speak English or Spanish, can access the internet weekly, and are overweight or obese. It's not for those in hospice care, had recent weight loss surgery, are pregnant, or have certain serious medical conditions.

Inclusion Criteria

I am 20 years old or older.

Have a primary care provider

Have a healthcare provider at BWH (received care from a primary care provider or specialist at BWH in last 24 months)

Exclusion Criteria

I am currently receiving comfort care, hospice, or living in a nursing home.

Patients who are pregnant

I have had weight loss surgery in the past year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Participants receive the combined intervention (online weight management program with patient navigator support and personalized coaching) as part of standard care for 12 months.

12 months

Ongoing virtual engagement

Follow-up

Participants are monitored for maintenance of weight change and other health outcomes six months after completing the intervention.

6 months

Treatment Details

Interventions

• Online Weight Management Program with Coaching and Patient Navigator Support

Trial Overview The study tests an online weight management program combined with coaching and patient navigator support to improve obesity outcomes. The intervention will be adapted across various settings involving diverse patients from BWH to see how well it works.

Participant Groups

Group I: Intervention Implementation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

The Healthy Weight Coaching (HWC) program is a comprehensive 12-month internet-based intervention for obesity management that combines Acceptance and Commitment Therapy with personalized coaching, targeting diet, physical activity, psychological factors, and sleep.

With 1189 participants enrolled, the program emphasizes ongoing support through weekly weight logs and 26 scheduled online discussions with coaches, aiming to provide effective long-term weight management solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. Suojanen, LU., Ahola, AJ., Kupila, S., et al.[2022]

The telehealth-based lifestyle therapeutics (THBC) program was effective in promoting weight loss, with obese participants losing an average of 3.6% of their body weight compared to 2.5% for overweight participants, indicating a significant difference based on initial BMI category.

There were no differences in weight loss outcomes between men and women, and participants reported high satisfaction with the program, suggesting that THBC is a valuable tool for weight management in an employer population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Sex Differences in the Effectiveness of Telehealth-Based Health Coaching in Weight Management in an Employee Population. Johnson, KE., Alencar, MK., Miller, B., et al.[2021]

A feasibility study involving 25 obese hospitalized patients showed that a comprehensive weight loss intervention, including counseling and follow-up, is practical and can be implemented effectively during hospital stays.

Patients in the intervention group lost an average of 3.0 kg over 6 months, while the control group gained weight, indicating that the intervention may lead to sustained weight loss improvements post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospitalists' utilization of weight loss resources with discharge texts and primary care contact: a feasibility study. Harris, CM., Cheskin, LJ., Khaliq, W., et al.[2016]

A study involving 154 overweight or obese patients showed that those referred to an automated Internet-based behavioral weight-loss intervention lost significantly more weight than those in an education-only control group, with average losses of 5.5 kg at 3 months and 5.4 kg at 6 months.

Over half of the participants in the Internet-based intervention achieved a clinically significant weight loss of 5% or more of their initial body weight, indicating the intervention's effectiveness in promoting weight control behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. Thomas, JG., Leahey, TM., Wing, RR.[2022]

In a study involving 8112 overweight/obese Australian adults over 12 weeks, web-based weight loss programs with supportive features led to higher engagement compared to information-only sites, but did not result in significantly greater weight loss.

While personalized meal planning and social networking features did not enhance weight loss outcomes, increased usage of the weight tracker tool was linked to better weight loss results among participants using supportive websites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features predicting weight loss in overweight or obese participants in a web-based intervention: randomized trial. Brindal, E., Freyne, J., Saunders, I., et al.[2022]

A randomized control trial involving 60 obese students showed that a self-empowerment-based coaching program significantly reduced total body fat and improved healthy behavior habits compared to a control group.

The intervention group also reported greater improvements in satisfaction related to hobbies, exercise, sleep, and spiritual well-being, indicating a holistic benefit of the coaching approach in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. Dewi, DK., Sekartini, R., Sunardi, D., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The role of nurse support within an Internet-delivered weight management intervention: A qualitative study. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Exploring Sex Differences in the Effectiveness of Telehealth-Based Health Coaching in Weight Management in an Employee Population. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

PROVIDER PRACTICE HABITS AND BARRIERS TO CARE IN OBESITY MANAGEMENT IN A LARGE MULTICENTER HEALTH SYSTEM. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Hospitalists' utilization of weight loss resources with discharge texts and primary care contact: a feasibility study. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Web-based weight loss in primary care: a randomized controlled trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Web based Health Education, E-learning, for weight management. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Features predicting weight loss in overweight or obese participants in a web-based intervention: randomized trial. [2022]

11. India pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Case management via telephone counseling and SMS for weight maintenance in adolescent obesity: study concept of the TeAM program. [2020]