ObesityNCT05544708
Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management
A study testing Wellness Engagement 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 program being tested in this research study aims to address these factors and increase 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?
- Wellness Engagement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 and older
- Resident of Petersburg, VA
- Interested in engaging community members in healthy lifestyle changes (e.g., walking, small changes to eating) and willing to engage in these behaviors her/himself
Who cannot join
- A diagnosis of type 1 diabetes mellitus.
- Currently being treated for cancer.
- Medical conditions that may increase risk for participating in unsupervised exercise, if medical clearance is not provided
- Hospitalization for depression or other psychiatric disorder within the past 12 months.
- Lifetime history of bipolar disorder or psychotic disorder.
- Currently pregnant or lactating, or planning to become pregnant within the study period.
Show all 10Show fewer
- Current involvement in a weight loss program or current use of weight loss medication.
- Inability to speak, read and write English.
- Planning to move from the Petersburg area within the study period.
- Does not have sufficient numbers of individuals in their social network from which to recruit for the proposed study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management-Phase I
African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The program being tested in this research study aims to address these factors and increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for delivering a weight-management program in a real-world, community-based setting.
Read the detailed description
Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks.
- Conditions
- Obesity
- Being tested
- Wellness Engagement 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.
Wellness Engagement InterventionBehavioural
Train for, recruit participants into, and lead a 12-week lifestyle intervention delivered via weekly group meetings
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. HCL in the intervention group will deliver the intervention immediately following baseline visits and randomization. Receives: Behavioral: Wellness Engagement Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: House Chat Leaders (HCL)
House Chat Leaders (HCL) will undergo training to recruit and deliver a lifestyle intervention to members of their social networks.
Measured: 18 months
Feasibility: Participants
The total number of participants recruited by the HCLs. The pre-specified goal is 80 participants overall (approximately 8 per house chat). A total of 71 individuals were interested and completed initial pre-screening. Of those, 43 were eligible and consented to participate. One individual did not complete their baseline visit, leaving 42 participants randomization eligible.
Measured: 18 months
Feasibility: Delivery Model
The number of intervention sessions delivered as planned. The pre-specified threshold was 70% of sessions.
Measured: 12 weeks
Secondary outcomes (2)
Acceptability: Attendance
The average number of sessions attended by participants. The pre-specified threshold was 70% of sessions.
Measured: 12 weeks
Acceptability: Retention
The percentage of participants who are retained in the program. The pre-specified target to demonstrate acceptability was 80% retention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 May 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Single arm for Phase I
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moghboeba Mosavel, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544708
- Sponsor's protocol ID
- HM20024014
- Other IDs
- 1R01DK132373
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2022
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management-Phase I
- ClinicalTrials.gov ID
- NCT05544708
- Acronym / sponsor ID
- HM20024014
- Conditions
- Obesity
- Keywords
- cardiometabolic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Posted 18 Sep 2026
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 program being tested in this research study aims to address these factors and increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for delivering a weight-management program in a real-world, community-based setting.
Detailed description
Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm for Phase I
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Wellness Engagement InterventionWellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. HCL in the intervention group will deliver the intervention immediately following baseline visits and randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- Resident of Petersburg, VA
- Interested in engaging community members in healthy lifestyle changes (e.g., walking, small changes to eating) and willing to engage in these behaviors her/himself
Key exclusion criteria (10 listed)
- A diagnosis of type 1 diabetes mellitus.
- Currently being treated for cancer.
- Medical conditions that may increase risk for participating in unsupervised exercise, if medical clearance is not provided
- Hospitalization for depression or other psychiatric disorder within the past 12 months.
- Lifetime history of bipolar disorder or psychotic 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 |
|---|---|---|
| Wellness Engagement InterventionTrain for, recruit participants into, and lead a 12-week lifestyle intervention delivered via weekly group meetings | Behavioural | Intervention |
Primary outcome
Feasibility: House Chat Leaders (HCL)
Time frame: 18 months
House Chat Leaders (HCL) will undergo training to recruit and deliver a lifestyle intervention to members of their social networks.
Feasibility: Participants
Time frame: 18 months
The total number of participants recruited by the HCLs. The pre-specified goal is 80 participants overall (approximately 8 per house chat). A total of 71 individuals were interested and completed initial pre-screening. Of those, 43 were eligible and consented to participate. One individual did not complete their baseline visit, leaving 42 participants randomization eligible.
Feasibility: Delivery Model
Time frame: 12 weeks
The number of intervention sessions delivered as planned. The pre-specified threshold was 70% of sessions.
2 secondary outcomes
Acceptability: Attendance
Time frame: 12 weeks
Acceptability: Retention
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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, PhD 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 Wellness Engagement 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 3 inclusion and 10 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 18 Sep 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?
Yes. Results are posted in the registry (first posted 18 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility: House Chat Leaders (HCL) (time frame: 18 months). The study lists 3 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 18 Sep 2026.