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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online weight management program combined with coaching and patient navigator support to improve outcomes for individuals with overweight or obesity. The researchers aim to evaluate the program's effectiveness in various clinical and community settings connected to Brigham and Women's Hospital. Individuals with a BMI of 30 or higher, or a BMI between 25 and 29.9 accompanied by health issues like type 2 diabetes or high blood pressure, and internet access, may qualify. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future weight management strategies.

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 prior data suggests that this online weight management program with coaching and patient navigator support is safe?

Research has shown that the online weight management program, which includes coaching and support from a patient navigator, is generally safe for people with obesity. In a study with 840 participants who had obesity and conditions like high blood pressure or type 2 diabetes, researchers reported no major safety issues as participants lost weight over 12 months.

These results suggest that the program is well-tolerated. The combination of online support, coaching, and navigator assistance appears to aid in safe weight management. Although no major side effects were noted, individuals should consider their own health conditions and consult their healthcare provider before starting the program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this online weight management program because it combines personalized coaching with patient navigator support, offering a dynamic and interactive approach to tackling obesity. Unlike traditional treatments such as prescribed diets, exercise regimens, or medication, this program leverages technology to provide real-time support and guidance tailored to each participant's needs. The inclusion of a patient navigator is particularly innovative, as it helps individuals overcome personal barriers to weight loss by providing continuous motivation and assistance. This comprehensive and personalized approach has the potential to engage patients more effectively and support sustained weight loss outcomes.

What evidence suggests that this online weight management program with coaching and patient navigator support is effective for obesity?

Research has shown that online weight management programs, particularly those with coaching and support from patient guides, can effectively help people manage obesity. Studies have found that these programs encourage long-term behavioral changes, which are crucial for weight management. This trial will evaluate an online weight management program with coaching and patient navigator support, aiming to make weight management easier and more supportive, thus increasing the chances of successful weight loss. There is a strong need for an online program that can be widely used in medical settings to treat obesity, and such programs have shown promising results in improving patient health. Overall, evidence suggests these programs can lead to significant improvements for those dealing with obesity. ^{1 3 4 5 6}

Who Is on the Research Team?

Heather J Baer, Sc.D.

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7451764/

Effectiveness of a web-based real-life weight management ... In conclusion, the HWC is a multi-component program designed to help adult patients with overweight or obesity make long-term behavioural changes in order to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10748868/

Implementation of a Scalable Online Weight Management ... Abstract. Introduction. There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings.

3. withpower.com withpower.com/trial/phase-obesity-8-2022-d052d

Online Weight Management Program for Obesity ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442030104X

Integrating an online weight management program with ... Weight management treatment modalities in patients with overweight or obesity: A retrospective cohort study of administrative claims data. 2023, Obesity Pillars.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838318

Peer Coaching to Support Weight Management in Primary ... However, only 40% of adults with overweight or obesity reported receiving weight counseling, and less than 8% of eligible veterans attended the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7610192/

Effect of an Online Weight Management Program ... In this cluster randomized trial of 840 patients with overweight or obesity and a diagnosis of hypertension or type 2 diabetes, the mean weight loss at 12 ...