Georgia CEAL RESTORES Family Diabetes Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorMorehouse School of Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Family Diabetes Prevention
BehavioralA weekly lifestyle modification program for families with at least one parent at high risk of developing diabetes.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Single arm pre/post studyExperimental treatment 1 intervention
Trial outcomes
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Morehouse School of Medicine
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov