OverweightPROPS2NCT05553925
Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0
A study testing Online Weight Management Program with Coaching and Patient Navigator Support in people with Overweight and Obesity, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Online Weight Management Program with Coaching and Patient Navigator Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Implementation of an Online Weight Management Program in Clinical and Community Settings
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:
Read more
- To improve management of overweight and obesity in clinical and community settings.
- 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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Online Weight Management Program with Coaching and Patient Navigator Support
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Weight Management Program with Coaching and Patient Navigator SupportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Online Weight Management Program with Coaching and Patient Navigator Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (10)
Reach
The number, proportion, and description of end-users receiving the intervention, including the number of patients who are referred by their provider, who are identified via the electronic health record, or who self-refer to the program. Data from the electronic health record and other internal databases will be used to track the total number and proportion of patients who are referred or identified, as well as the number and proportion who are screened, eligible, enrolled, and registered for the program.
Measured: Every month for 14 months
Patient Satisfaction
Patient satisfaction with the intervention as self-reported by patients on surveys and during interviews. Data also will identify barriers and facilitators.
Measured: 12 months after enrollment in the program
Diet
Changes in patients' diet during the 12-month intervention, as self-reported on surveys.
Measured: Baseline and 12 months
Physical Activity
Changes in patients' physical activity during the 12-month intervention, as self-reported on surveys.
Measured: Baseline and 12 months
Health Status
Changes in patients' health status during the 12-month intervention, as self-reported on surveys.
Measured: Baseline and 12 months
Self-efficacy Around Weight Loss
Changes in patients' self-efficacy around weight loss during the 12-month intervention, as self-reported on surveys.
Measured: Baseline and 12 months
Change in hemoglobin A1c (HbA1c)
Changes in Hb1Ac over 12 months (only among patients with type 2 diabetes). This will be calculated from HbA1c values recorded in the electronic health record.
Measured: Baseline and 12 months
Changes in Blood Pressure
Changes in systolic and diastolic blood pressure over 12 months. This will be calculated from blood pressure values recorded in the electronic health record.
Measured: Baseline and 12 months
Engagement with the Online Program
Engagement with the online program will be measured by the number/proportion of enrolled patients who engage with each of the following components of the online program: log meals, text and/or call coach, log sleep, log weight, complete an activity, complete a lesson. Data will be retrieved from the vendor database.
Measured: During 12 months of enrollment in the program
Weight Change at 18 Months
Weight change at 18 months. This will be calculated from weight values recorded in the patients' electronic health records and will be used to evaluate whether patients maintained weight lost at 12 months (primary outcome) at 18 months, six months after they complete the online program.
Measured: 18 Months (six months after program completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start3 Nov 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Heather J. Baer, Brigham and Women's Hospital
- Investigators
- Heather J Baer, Sc.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553925
- Sponsor's protocol ID
- 2022P000605
- Acronym
- PROPS2
- Status last verified
- Jan 2025
- First submitted
- 18 Aug 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baer HJ, Cho J, Fay R, Apovian CM, McCarthy AC, Blood AJ, Samal L, Fisher NDL, Orav EJ, Wien M, Plutzky J, Block JP, Bates DW, Rozenblum R, Tucci M, McPartlin M, Oates M, McManus KD, Scirica BM. Engagement and Weight Change in an Online Weight Management Program in Clinical Settings: An Implementation Project. J Gen Intern Med. 2026 Jun 3. doi: 10.1007/s11606-026-10493-5. Online ahead of print.
PubMed 42234371
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Online Weight Management Program in Clinical and Community Settings
- ClinicalTrials.gov ID
- NCT05553925
- Acronym / sponsor ID
- PROPS2 / 2022P000605
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Aug 2025 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To improve management of overweight and obesity in clinical and community settings.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Implementation | Experimental | Other: Online Weight Management Program with Coaching and Patient Navigator SupportAt 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 may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Weight Management Program with Coaching and Patient Navigator SupportPatients 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. | Other | Intervention Implementation |
Primary outcome
Weight Change
Time frame: Baseline and 12 months
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.
10 secondary outcomes
Reach
Time frame: Every month for 14 months
Patient Satisfaction
Time frame: 12 months after enrollment in the program
Diet
Time frame: Baseline and 12 months
Physical Activity
Time frame: Baseline and 12 months
Health Status
Time frame: Baseline and 12 months
Self-efficacy Around Weight Loss
Time frame: Baseline and 12 months
Change in hemoglobin A1c (HbA1c)
Time frame: Baseline and 12 months
Changes in Blood Pressure
Time frame: Baseline and 12 months
Engagement with the Online Program
Time frame: During 12 months of enrollment in the program
Weight Change at 18 Months
Time frame: 18 Months (six months after program completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 42234371Baer HJ, Cho J, Fay R, Apovian CM, McCarthy AC, Blood AJ, Samal L, Fisher NDL, Orav EJ, Wien M, Plutzky J, Block JP, Bates DW, Rozenblum R, Tucci M, McPartlin M, Oates M, McManus KD, Scirica BM. Engagement and Weight Change in an Online Weight Management Program in Clinical Settings: An Implementation Project. J Gen Intern Med. 2026 Jun 3. doi: 10.1007/s11606-026-10493-5. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather J Baer, Sc.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Weight Management Program with Coaching and Patient Navigator Support in people with Overweight and Obesity, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.