An interventional study of Family Diabetes Prevention in Weight Reduction and Prediabetes, sponsored by Morehouse School of Medicine. Recruiting at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Morehouse School of Medicine · Not applicable, Interventional, and Prevention
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.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Morehouse School of Medicine is the lead sponsor of 22 studies on the registry; 11 are open to participants now.
Compared within Prediabetic State, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Family Diabetes Prevention
A weekly lifestyle modification program for families with at least one parent at high risk of developing diabetes.
Also known as: Family DPP+
Weight Reduction
Weight at 12 weeks (post intervention) and three month follow up
Time frame: From enrollment to the end of intervention at 6 months
Plan to share: Yes — De-identified individual data will be shared with the NIH CEAL National Network.
Supporting information: Study protocol
Time frame: Data are shared with the NIH CEAL Network biannually.
Access criteria: Members of the NIH CEAL Network will have access based on the data use agreements in place.
Data sharing details ↗ · ceal.nih.gov
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Morehouse School of Medicine