Obesity
Conditions
Keywords
cardiometabolic disease
Brief 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. 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.
Interventions
BEHAVIORALWellness Engagement Intervention
Train for, recruit participants into, and lead a 12-week lifestyle intervention delivered via weekly group meetings
Sponsors
Virginia Commonwealth University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Single arm for Phase I
Intervention model description
Single arm for Phase I
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: House Chat Leaders (HCL) | 18 months | House Chat Leaders (HCL) will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. |
| Feasibility: Participants | 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 | 12 weeks | The number of intervention sessions delivered as planned. The pre-specified threshold was 70% of sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: Attendance | 12 weeks | The average number of sessions attended by participants. The pre-specified threshold was 70% of sessions. |
| Acceptability: Retention | 12 weeks | The percentage of participants who are retained in the program. The pre-specified target to demonstrate acceptability was 80% retention. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMoghboeba Mosavel, PhD
Virginia Commonwealth University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
None listed