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 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.
Interventions
BEHAVIORAL12-week lifestyle intervention
A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes
Sponsors
Virginia Commonwealth University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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).
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 or older * Resident of Petersburg, VA
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants. | 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. | 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. | 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. | 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. | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMoghboeba Mosavel
Virginia Commonwealth University
Outcome results
None listed