ObesityNCT06172582
WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)
A study testing 12-week lifestyle intervention in people with Obesity, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and improve cardiometabolic health outcomes for the study population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 12-week lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 or older
- Resident of Petersburg, VA
Who cannot join
- Dx of type 1 diabetes mellitus
- Current treatment for cancer
- Medical conditions that may increase risk for participating in unsupervised physical activity unless medical provider provides consent for participation
- Hospitalization for depression or other psychiatric disorder within the past 12 months
- Uncontrolled psychotic disorder or bipolar disorder
- Currently pregnant or lactating or planning to become pregnant within the study period
Show all 9Show fewer
- Current involvement in a weight loss program or current use of weight loss medication
- Inability to speak and read English
- Planning to move from the Petersburg area within the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: WE Project: 2.0 Grassroots Wellness Coaching. Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management (Phase 2)
African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and improve cardiometabolic health outcomes for the study population. The purpose of this research study is to find out about the feasibility, acceptability and preliminary effectiveness of using house chats (HC) as a model for a weight management program in a real-world, community-based setting.
Read the detailed description
The pilot trial will utilize a cluster randomized controlled design to assess the feasibility, acceptability, and preliminary effectiveness of the house chat model as a grassroots approach to lifestyle intervention delivery in a community setting. Four wards will be randomly assigned to either intervention or a delayed intervention control. A total of 10 HCL will be recruited and trained across the two wards (5 in the intervention ward and 5 in delayed intervention ward). HCL will recruit members of their social network (>18 years of age) to participate in a 12-week lifestyle intervention delivered via weekly group meetings in the HCL's homes. The primary goal is to understand the feasibility and acceptability of this novel approach to intervention delivery, and as such, process data on recruitment, training, fidelity of intervention delivery, and satisfaction with the sessions will be collected on a weekly basis. In addition, in-person assessment visits will take place at 0, 12 weeks (post-treatment) and 24 weeks (follow up) to determine the preliminary effectiveness of this intervention to promote positive changes on adiposity (weight and waist circumference), other cardiometabolic risk factors (e.g., fasting glucose) and behavioral risk factors (physical activity and diet quality). In addition, the investigators will employ a mixed methods approach (process data, surveys, in-depth interviews with HCL, participants and key stakeholders) to assess factors that might promote and / or interfere with sustainability over long-term follow up to inform our future clinical trial.
- Conditions
- Obesity
- Being tested
- 12-week lifestyle intervention
- Keywords
- Cardiometabolic Disease
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week lifestyle interventionBehavioural
A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be randomized to intervention and will receive the 12-week program. Receives: Behavioral: 12-week lifestyle intervention |
| Delayed Intervention Control | Active comparator | Participants will be randomized to delayed intervention control and will receive the same 12-week program following the 24-week assessment. Receives: Behavioral: 12-week lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.
Measured: 12 week and 24 weeks post-treatment
Participants in the intervention will manifest clinically significant improvements in waist circumference with a signal for differential benefit compared to delayed intervention participants.
Waist circumference will be measured using a Gulik tape measure at the midpoint between the highest point of the iliac crest and the lowest part of the costal margin in the mid-axillary line.
Measured: 12 week and 24 weeks post-treatment
Participants will experience clinically significant improvements in fasting glucose with a signal for differential benefit compared to delayed intervention participants.
Finger-prick blood sample via a point-of-care Accu-Check glucometer will be used to obtain fasting glucose.
Measured: 12 week and 24 weeks post-treatment
Participants in the intervention will manifest clinically significant change in physical activity outcomes targeted in the intervention.
Physical activity will be objectively assessed via accelerometers. Total minutes of physical activity is the main outcome, but we will also examine minutes of light and moderate-to-vigorous physical activity. The threshold for clinically meaningful is 150 minutes / week which is consistent with a wealth of evidence and current evidence-based guidelines.
Measured: 12 week and 24 weeks post-treatment
Participants in the intervention ward will manifest clinically significant improvements in dietary quality outcomes targeted in the intervention.
The EARLY Trials 4-item Sugar Sweetened Beverage Questionnaire and 10-item NCI fruit and vegetable screener (all day version) to assess changes in core intervention targets will be administered. While any changes improvements in these outcomes would be meaningful if sustained over time, the results we will also will compare to current American Heart Association guidelines / recommendations
Measured: 12 week and 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start28 Nov 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The pilot trial will utilize a cluster randomized controlled design to assess the feasibility, acceptability, and preliminary effectiveness of the house chat model as a grassroots approach to lifestyle intervention delivery in a community setting. Four wards will be randomly assigned to either intervention or a delayed intervention control.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moghboeba Mosavel, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172582
- Sponsor's protocol ID
- HM20024014 Phase 2
- Other IDs
- 1R01DK132373
- Status last verified
- Oct 2025
- First submitted
- 9 Nov 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WE Project: 2.0 Grassroots Wellness Coaching. Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management (Phase 2)
- ClinicalTrials.gov ID
- NCT06172582
- Acronym / sponsor ID
- HM20024014 Phase 2
- Conditions
- Obesity
- Keywords
- Cardiometabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 15 Dec 2023 (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.
African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and improve cardiometabolic health outcomes for the study population. The purpose of this research study is to find out about the feasibility, acceptability and preliminary effectiveness of using house chats (HC) as a model for a weight management program in a real-world, community-based setting.
Detailed description
The pilot trial will utilize a cluster randomized controlled design to assess the feasibility, acceptability, and preliminary effectiveness of the house chat model as a grassroots approach to lifestyle intervention delivery in a community setting. Four wards will be randomly assigned to either intervention or a delayed intervention control. A total of 10 HCL will be recruited and trained across the two wards (5 in the intervention ward and 5 in delayed intervention ward). HCL will recruit members of their social network (>18 years of age) to participate in a 12-week lifestyle intervention delivered via weekly group meetings in the HCL's homes. The primary goal is to understand the feasibility and acceptability of this novel approach to intervention delivery, and as such, process data on recruitment, training, fidelity of intervention delivery, and satisfaction with the sessions will be collected on a weekly basis. In addition, in-person assessment visits will take place at 0, 12 weeks (post-treatment) and 24 weeks (follow up) to determine the preliminary effectiveness of this intervention to promote positive changes on adiposity (weight and waist circumference), other cardiometabolic risk factors (e.g., fasting glucose) and behavioral risk factors (physical activity and diet quality). In addition, the investigators will employ a mixed methods approach (process data, surveys, in-depth interviews with HCL, participants and key stakeholders) to assess factors that might promote and / or interfere with sustainability over long-term follow up to inform our future clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The pilot trial will utilize a cluster randomized controlled design to assess the feasibility, acceptability, and preliminary effectiveness of the house chat model as a grassroots approach to lifestyle intervention delivery in a community setting. Four wards will be randomly assigned to either intervention or a delayed intervention control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: 12-week lifestyle interventionParticipants will be randomized to intervention and will receive the 12-week program. |
| Delayed Intervention Control | Active comparator | Behavioral: 12-week lifestyle interventionParticipants will be randomized to delayed intervention control and will receive the same 12-week program following the 24-week assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 or older
- Resident of Petersburg, VA
Key exclusion criteria (9 listed)
- Dx of type 1 diabetes mellitus
- Current treatment for cancer
- Medical conditions that may increase risk for participating in unsupervised physical activity unless medical provider provides consent for participation
- Hospitalization for depression or other psychiatric disorder within the past 12 months
- Uncontrolled psychotic disorder or bipolar disorder
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 |
|---|---|---|
| 12-week lifestyle interventionA 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes | Behavioural | Delayed Intervention Control, Intervention |
Primary outcome
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.
Time frame: 12 week and 24 weeks post-treatment
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.
Participants in the intervention will manifest clinically significant improvements in waist circumference with a signal for differential benefit compared to delayed intervention participants.
Time frame: 12 week and 24 weeks post-treatment
Waist circumference will be measured using a Gulik tape measure at the midpoint between the highest point of the iliac crest and the lowest part of the costal margin in the mid-axillary line.
Participants will experience clinically significant improvements in fasting glucose with a signal for differential benefit compared to delayed intervention participants.
Time frame: 12 week and 24 weeks post-treatment
Finger-prick blood sample via a point-of-care Accu-Check glucometer will be used to obtain fasting glucose.
Participants in the intervention will manifest clinically significant change in physical activity outcomes targeted in the intervention.
Time frame: 12 week and 24 weeks post-treatment
Physical activity will be objectively assessed via accelerometers. Total minutes of physical activity is the main outcome, but we will also examine minutes of light and moderate-to-vigorous physical activity. The threshold for clinically meaningful is 150 minutes / week which is consistent with a wealth of evidence and current evidence-based guidelines.
Participants in the intervention ward will manifest clinically significant improvements in dietary quality outcomes targeted in the intervention.
Time frame: 12 week and 24 weeks post-treatment
The EARLY Trials 4-item Sugar Sweetened Beverage Questionnaire and 10-item NCI fruit and vegetable screener (all day version) to assess changes in core intervention targets will be administered. While any changes improvements in these outcomes would be meaningful if sustained over time, the results we will also will compare to current American Heart Association guidelines / recommendations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Related trials for Obesity
RecruitingPhase 3
Vibegron for ENergy Thinking and Resilience in Aging
Obesity
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
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.
Moghboeba Mosavel principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week lifestyle intervention in people with Obesity, run by Virginia Commonwealth University 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 13 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants. (time frame: 12 week and 24 weeks post-treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.