Status:
COMPLETED
Family Diabetes Prevention Program Pilot Study
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
PreDiabetes
Overweight and Obesity
Eligibility:
All Genders
5+ years
Phase:
NA
Brief Summary
This study will examine the feasibility and acceptability of a family-oriented augmentation of the Diabetes Prevention Program lifestyle intervention (DPP), called the Family DPP. It will also prelimi...
Eligibility Criteria
Inclusion
- Inclusion Criteria for the Intervention Arm:
- For ADULT participants, inclusion criteria are:
- Meeting eligibility criteria for the CDC's National Diabetes Prevention Program lifestyle intervention, which are:
- 18 years of age and older;
- not pregnant at time of enrollment;
- body mass index (BMI) of ≥25 kg/m2 (≥23 kg/m2 , if of Asian race);
- meet one of the following: a) have prediabetes (defined as fasting glucose of 100-125 mg/dL; plasma glucose measured 2 hours after 75 gm glucose load of 140 to 199 mg/dL, or A1c of 5.7% to 6.4%); b) history of clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy; c) high risk for diabetes based on CDC or American Diabetes Association (ADA) Diabetes Screening Test).
- AND
- being a primary caregiver of at least one eligible child aged 5 through 12 years at time of recruitment (defined as caring for the child, with a responsibility for the child's food, sleep and activity habits, at least 3 days out of the week)
- For CHILD participants, inclusion criteria are:
- being aged 5 through 12 years at time of recruitment;
- not having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals; AND
- not concurrently enrolled in a structured weight management program.
- Exclusion Criteria for Intervention Arm:
- For ADULT participants, exclusion criteria include
- Conditions that would exclude their participation in the DPP lifestyle intervention which include:
- pregnancy;
- having end-stage renal disease;
- having type 1 or type 2 diabetes.
- They will also be excluded if they are concurrently enrolled in a structured weight management program.
- For CHILD participants: exclusion criteria include:
- having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals;
- being enrolled in a structured weight management program.
- For the Control Arm/Concurrent Control Group, this will only enroll ADULT participants.
- The inclusion criteria are:
- Being a participant in the Brancati Center's Diabetes Prevention Program, in a group that has started within 6 months of Intervention Arm group start
- Lives with a child less than 18 years of age in their household
Exclusion
Key Trial Info
Start Date :
July 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05358444
Start Date
July 8 2022
End Date
February 19 2024
Last Update
July 8 2025
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205