Family Diabetes Prevention Program Pilot Study

Johns Hopkins University

Status: Completed

Conditions: Overweight, Childhood; Lifestyle, Healthy; Obesity, Childhood; Overweight and Obesity; Type 2 Diabetes; PreDiabetes

Treatments: Behavioral: Family Diabetes Prevention Program (Family DPP); Behavioral: National Diabetes Prevention Program Lifestyle Intervention (DPP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05358444

1K23DK119581-01A1 (U.S. NIH Grant/Contract)

IRB00310219

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for the Intervention Arm:

• For ADULT participants, inclusion criteria are:

  1. Meeting eligibility criteria for the CDC's National Diabetes Prevention Program lifestyle intervention, which are:

     1. 18 years of age and older;
     2. not pregnant at time of enrollment;
     3. body mass index (BMI) of ≥25 kg/m2 (≥23 kg/m2 , if of Asian race);
     4. 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

  2. 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:

  1. being aged 5 through 12 years at time of recruitment;
  2. not having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals; AND
  3. not concurrently enrolled in a structured weight management program.

Exclusion Criteria for Intervention Arm:

• For ADULT participants, exclusion criteria include

  1. Conditions that would exclude their participation in the DPP lifestyle intervention which include:

     1. pregnancy;
     2. having end-stage renal disease;
     3. having type 1 or type 2 diabetes.

  2. They will also be excluded if they are concurrently enrolled in a structured weight management program.

• For CHILD participants: exclusion criteria include:

  1. having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals;

  2. 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:

  1. 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
  2. Lives with a child less than 18 years of age in their household

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Diabetes Prevention Program (DPP)

Active Comparator group

Description:

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.

Treatment:

Behavioral: National Diabetes Prevention Program Lifestyle Intervention (DPP)

Family Diabetes Prevention Program (Family DPP)

Experimental group

Description:

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.

Treatment:

Behavioral: Family Diabetes Prevention Program (Family DPP)