ClinicalTrials.gg
RecruitingNCT07808723GA CEALUpdated Sep 18, 2026

Georgia CEAL RESTORES Family Diabetes Study

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.

Primary conditionPrediabetic StateRegistry: Weight LossReclassifiedWhy we changed it
Registry
Weight Loss — the first condition term the registry derived for this study.
ClinicalTrials.gg
Prediabetic State
Why
  1. Weight Loss is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Prediabetic State.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Morehouse School of Medicine · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Weight Reduction
  • Prediabetes

Browse trials for

Keywords

  • Family-based diabetes prevention intervention
  • Cardiovascular Disease Prevention
03

In context

Prediabetic State Reclassified

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 →

Lead sponsor

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 →

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

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 ( 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

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 to physical activity or dietary changes
  • Currently pregnant or planning to become pregnant in the next year
  • Family lives outside of Georgia
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Single arm pre/post study

    Behavioral: Family Diabetes Prevention

Interventions

  • BehavioralFamily 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+

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07808723
Lead sponsor
Morehouse School of Medicine
Responsible party
Rakale Collins Quarells (Principal Investigator, Morehouse School of Medicine) — Principal investigator
First posted
Sep 9, 2026
Start date
Aug 29, 2026
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 18, 2026

Study contacts

Katrina M Brantley, DrPH
Contact
kbrantley@msm.edu
470-670-7840
Danielle M Duvernay, MSHI
Contact
dduvernay@msm.edu
404-756-1224
Rakale C Quarells, PhD
principal investigator · Morehouse School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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