Family Diabetes Prevention Program Pilot Study

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05358444
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • National Diabetes Prevention Program Lifestyle Intervention (DPP) — BEHAVIORAL
    The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
  • Family Diabetes Prevention Program (Family DPP) — BEHAVIORAL
    The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP supplement the DPP's sessions to additionally address barriers to adults' own lifestyle change efforts related to being a caregiver of children AND to introduce basic concepts regarding healthy child habits related to dietary intake, physical activity and screen time, and sleep. The Family DPP will involve thus additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, may also be engaged.

Study Details

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 preliminarily examine adult and child health and health behavior outcomes. The DPP is a 12-month, group-based lifestyle intervention for adults at high-risk for type 2 diabetes, in which adult participants learn skills and strategies to achieve the program's goals of 5% weight loss and 150 minutes/week of moderate-vigorous physical activity. The Family DPP will consist of all elements of the evidence-based DPP, along with augmentations including additional child-focused sessions in which adult participants will learn about principles and strategies for promoting healthy lifestyle behaviors in children, ages 5 through 12 years. Children may participate in certain child-focused sessions, too. The non-randomized pilot feasibility study will consists of 2 arms/groups: 1) the concurrent "control" group, consisting of adults who are enrolled in the DPP; and 2) the "intervention" arm, in which the adult participants will engage in the Family DPP (and children may participate in certain aspects of the Family DPP focused on children). The study will recruit 10-15 adult-child dyads, for the "intervention" groups, and 10-15 adults for the concurrent control group. In addition to data collected from adult participants as a routine part of the DPP, the study will examine additional adult health behaviors and health outcomes and child health outcomes (change in body mass index z-score) and health behaviors at baseline, 6 months and 12 months (program end) among participants in the "intervention" group.

Key Dates

Start date
Jul 8, 2022
Status verified
Jun 2025
Primary completion
Feb 19, 2024
Completion
Feb 19, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Diabetes Prevention Program (DPP)
    Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households.
  • Experimental: Family Diabetes Prevention Program (Family DPP)
    Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. These groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate.

Primary Outcome Measure

Adult Participant Attendance in Program as Assessed by Total Number of Required Program Sessions Attended, Core [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21205-

Find similar trials in Baltimore, MD

By condition
Obesity / overweightType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Johns Hopkins University School of Medicine· Baltimore, MD

Related Studies