Weight ReductionGA CEALNCT07808723
Georgia CEAL RESTORES Family Diabetes Study
A study testing Family Diabetes Prevention in people with Weight Reduction and Prediabetes, run by Morehouse School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Reduction, Prediabetes
- What is being tested?
- Family Diabetes Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Morehouse School of Medicine
Atlanta, Georgia, 30310
Katrina M Brantley, DrPH, 470-670-7840, kbrantley@msm.edu
Danielle M Duvernay, MSHI, 404-756-1224, dduvernay@msm.edu
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Weight Reduction, Prediabetes
- Being tested
- Family Diabetes Prevention
- Keywords
- Family-based diabetes prevention intervention, Cardiovascular Disease Prevention
- Medical subject headings
- Weight Loss, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Diabetes PreventionBehavioural
Also called Family DPP+
A weekly lifestyle modification program for families with at least one parent at high risk of developing diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Single arm pre/post study | Experimental | Not described Receives: Behavioral: Family Diabetes Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Reduction
Weight at 12 weeks (post intervention) and three month follow up
Measured: From enrollment to the end of intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start29 Aug 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Rakale Collins Quarells, Morehouse School of Medicine
- Investigators
- Rakale C Quarells, PhD, Principal investigator, Morehouse School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808723
- Sponsor's protocol ID
- IRB-FY2025-50
- Other IDs
- 1OT2HL156812-01
- Acronym
- GA CEAL
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data will be shared with the NIH CEAL National Network.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Engaged Alliance-Reimagined Environments and Systems Together for Outcomes Georgia Through Research and Evaluation for Sustainability (RESTORES) - Georgia CEAL RESTORES
- ClinicalTrials.gov ID
- NCT07808723
- Acronym / sponsor ID
- GA CEAL / IRB-FY2025-50
- Conditions
- Weight Reduction, Prediabetes
- Keywords
- Family-based diabetes prevention intervention, Cardiovascular Disease Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Aug 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm pre/post study | Experimental | Behavioral: Family Diabetes Prevention |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Diabetes PreventionAlso: Family DPP+A weekly lifestyle modification program for families with at least one parent at high risk of developing diabetes. | Behavioural | Single arm pre/post study |
Primary outcome
Weight Reduction
Time frame: From enrollment to the end of intervention at 6 months
Weight at 12 weeks (post intervention) and three month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual data will be shared with the NIH CEAL National Network.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rakale C Quarells, PhD principal investigator
Morehouse School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Diabetes Prevention in people with Weight Reduction and Prediabetes, run by Morehouse School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrina M Brantley, DrPH (470-670-7840, kbrantley@msm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Reduction (time frame: From enrollment to the end of intervention at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.