AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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.

Katrina M Brantley, DrPH contact

470-670-7840

kbrantley@msm.edu

Danielle M Duvernay, MSHI contact

404-756-1224

dduvernay@msm.edu

United States1 site, 1 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

    Recruiting

Other trials in United States

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.

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 groups in NCT07808723
Study groupRoleWhat they receive
Single arm pre/post studyExperimentalNot described
Receives: Behavioral: Family Diabetes Prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted9 Sep 2026
  2. Study start29 Aug 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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)
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.

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in