Georgia CEAL RESTORES Family Diabetes Study
Sponsored by Morehouse School of Medicine
About this study
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.
The intervention will test the following hypothesis: a) Parents enrolled in the family intervention will demonstrate a 4% reduction in weight by the end of the intervention. There will be three data collection time points for all enrolled participants: baseline (T1), post-intervention (12 weeks) (T2), and 3-month follow-up (T3). For each data collection time point, parents and children will complete questionnaires and clinical assessments. All survey data will be collected electronically using the secure research electronic data capture system (REDCap) which allows secure data capture from remote locations. Links to the surveys will be emailed to parents and children to access and complete intervention questionnaires or addition options to complete documentation using a study-issued iPad …
Where this study is enrolling
- I'm interested
Morehouse School of Medicine
Atlanta, Georgia
Who can participate
Inclusion criteria
- ✓Parent/guardian must identify as African American or Hispanic
- ✓Parent/guardian must be 18+ years residing in the same household as the child (i.e., biological or have legal guardianship for child)
- ✓Parent/guardian must have prediabetes (HbA1c level 5.7-6.4%) or be at risk of developing Type 2 diabetes using CDC's Pre-Diabetes Risk Test
- ✓Participant is willing to commit to participation in a 12-week, in-person, intervention study
- ✓No plans to move over the next 9-months
- ✓Parent/guardian should be ambulatory and able to participate in physical activity
- ✓Children must be between the ages of 12-17 years old
- ✓Child should be ambulatory and able to participate in physical activity
Exclusion criteria
- ✕Severe psychological disorders that may prevent/interfere with study -participation
- ✕Physical impairments that may prevent participation in moderate intensity physical activity
- ✕Previous diagnosis of diabetes
- ✕History of congestive heart failure
- ✕Renal failure
- ✕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
- ✕Currently pregnant or planning to become pregnant in the next year
- ✕Family lives outside of Georgia
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.