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Online Weight Management Program for Obesity (PROPS2 Trial)
N/A
Waitlist Available
Led By Heather J Baer, Sc.D.
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months (six months after program completion)
Awards & highlights
No Placebo-Only Group
Summary
This trial will improve management of obesity, improve outcomes among people with obesity, implement a combined intervention across multiple settings and a diverse cross-section of patients and providers, and create an implementation guide to aid others in similar efforts.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a non-drug intervention focusing on lifestyle changes through an online platform with professional support, typical medication side effects aren't expected. However, participants may experience stress or frustration related to behavior change.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months (six months after program completion)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months (six months after program completion)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Weight Change
Secondary study objectives
Change in hemoglobin A1c (HbA1c)
Changes in Blood Pressure
Diet
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention ImplementationExperimental Treatment1 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.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,838,466 Total Patients Enrolled
47 Trials studying Obesity
273,124 Patients Enrolled for Obesity
Patient-Centered Outcomes Research InstituteOTHER
576 Previous Clinical Trials
27,074,687 Total Patients Enrolled
17 Trials studying Obesity
3,379,667 Patients Enrolled for Obesity
Heather J Baer, Sc.D.Principal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 20 years old or older.I am currently receiving comfort care, hospice, or living in a nursing home.I have had weight loss surgery in the past year.I speak English or Spanish.I have Type 1 diabetes or I am on insulin for my diabetes.My BMI is over 30, or between 25 and 29.9 with a condition like high blood pressure or diabetes.I do not have a condition where losing weight could harm me.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Implementation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.