Georgia CEAL RESTORES Family Diabetes Study
NCT07808723
Summary
The goal of this clinical trial is to determine whether a family-based lifestyle intervention reduces the risk of type 2 diabetes (T2D) among parents and their children. The intervention will also evaluate how well the program supports healthy lifestyle behaviors and family engagement. The primary outcome of this study is weight loss in parents. Researchers will evaluate changes in participants' weight and lifestyle behaviors before the study compared to the end of the study (12 weeks post intervention) and 3 months after participation in the program.
Eligibility
Inclusion Criteria: Parent/guardian must identify as African American or Hispanic, be 18+ years residing in the same household as the child (i.e., biological or have legal guardianship for child), have prediabetes (HbA1c level 5.7-6.4%) or determined to be at risk using CDC's Pre-Diabetes Risk Test, be willing to commit to participation in a 12-week intervention study, have no plans to move over the next 9-months, and are ambulatory and able to participate in physical activity. Children must be between the ages of 12-17 years old and are ambulatory and able to participate in physical activity. Exclusion Criteria: Participants will be excluded from the research study if the participant has severe psychological disorders that may prevent/interfere with study participation, physical impairments that may prevent participation in moderate intensity physical activity, have previous diagnosis of diabetes, have a history of congestive heart failure, renal failure, or recent (\<12 months) cardiovascular events such as myocardial infarction (heart attack) or stroke, taking medications that may affect endpoint analyses, have co-morbid contraindications to physical activity or dietary changes, or if the participant is currently pregnant or planning to become pregnant in the next year.
Conditions4
Locations1 site
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NCT07808723