Georgia CEAL RESTORES Family Diabetes Study

Community Engaged Alliance-Reimagined Environments and Systems Together for Outcomes Georgia Through Research and Evaluation for Sustainability (RESTORES) - Georgia CEAL RESTORES

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 or laptop once the participants arrive for the clinical assessment day. The study questionnaires will collect participant demographics, health history, physical activity (amount, type, and related behaviors), sedentary behaviors, dietary intake, diet behaviors, weight loss history, quality of life, and perceived stress.

Clinical assessments will include the collection of weight, height, blood pressure, and waist circumference. Additionally, parents will have their weight assessed weekly during the intervention.

The family (one adult with prediabetes or risk factors for developing diabetes and a child between the ages of 12 and 17 years old) will be asked to attend 12 weekly sessions at a community site. Each session will last about two hours and will include a family meal. During the weekly sessions, 10 families will learn together how to improve their stress management, triggers, cognitive strategies, social support, eating, and physical activity habits. Parents and children will have some sessions together and others that are separate.

Each session will include 15-30 minutes of walking, dancing, playing sports, or other activities that move the body and increase the heart rate. Parents/guardians and children will go into separate rooms to learn about different topics each week. Some of the topics are exercise, healthy eating, cooking, and managing stress. At the end of each session, families will come together to share a meal.

Recruitment and screening will occur at health fairs, community events, and through flyer distribution at local community sites (e.g., YMCAs, Boys & Girls Clubs, churches). Additional outreach will take place through partnerships with clinics and community-based organizations (CBOs) that serve families. Clinic and CBO staff will receive study information and be encouraged to share it with individuals who may be eligible. Flyers and presentations at community events will provide general study contact information (phone number and email). When potential participants contact the study team after receiving a flyer or attending a presentation, a research team member will describe the study purpose, participant roles, requirements, and time commitments. Individuals will have the opportunity to ask questions and receive additional details before being asked to provide verbal consent for screening.

Screening will involve parents responding to brief eligibility questions and completing the CDC Prediabetes Risk Test (a person with a high score on the online risk test, i.e., 5 or higher, is at significant risk for having prediabetes). Potential participants who meet screening criteria will receive additional information and be given an opportunity to ask questions before going through the informed consent process.

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.