Family Diabetes Prevention Program Pilot Study

NCT05358444 | Completed Results

• 2 other identifiers: IRB003102191K23DK119581-01A1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

Prediabetes; Diabetes Prevention; Child obesity; Child overweight; Obesity; Overweight; Lifestyle Change

Outcome Measures

Primary Outcomes (15)

• Adult Participant Attendance in Program as Assessed by Total Number of Required Program Sessions Attended, Core

  The average total number of required core period program sessions attended by the adult participant (inclusive of make-up sessions) including all DPP (and, if in Family DPP, additional Family DPP sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions and additional Family DPP sessions.

  6 months

• Adult Participant Attendance in Program as Assessed by Total Number of Program Sessions Attended, Full Program

  The average total number of all required sessions attended by the adult participant (inclusive of make-up sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions only, and additional required Family DPP sessions only (of which there were 10), and didactic/required child-focused sessions only (of which there were 8).

  12 months

• Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Core

  The average percentage of required core period program sessions attended by the adult participant (inclusive of make-up sessions) in each arm (denomiator of 18 for DPP, and 20 for Family DPP); for Family DPP adult participants this will also be examined for the subset of required DPP sessions only (denominator is 18) and additional Family DPP sessions only (of which there were 2).

  6 months

• Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Full Program

  The percentage of all required program sessions attended by the adult participant (inclusive of make-up sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions only, all additional Family DPP sessions only (of which there were 10), and child-focused DPP sessions only (of which there were 8).

  12 months

• Child Participant Attendance in Family Diabetes Prevention Program

  The percentage of required child-focused sessions (N=8) attended by the child participant will be examined for child participants in the Family DPP arm only.

  12 months

• Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected

  The percentage of total enrolled child participants (in the intervention arm) for whom BMI data and also child-health behavior data are collected will be examined for at baseline data collection point.

  Baseline

• Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected

  The percentage of total enrolled child participants (in the Family DPP interventionarm) for whom BMI data and also child-health behavior data are collected will be examined for the 6 month data point.

  6 months

• Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected

  The percentage of total enrolled child participants (in the Family DPP intervention arm) for whom BMI data and child-health behavior data are collected will be examined for the 12 month data point.

  12 months

• Satisfaction With Family Diabetes Prevention Program as Assessed by Study Team Designed Questionnaire

  Mean Likert-scale score (for most items, Likert scale on a range of 1 to 4; from strongly disagree (1) to strongly agree (4)), exploring satisfaction with Family DPP content and structure). Mean of participant choice is reported.

  12 months (end of intervention)

• Intervention Fidelity as Assessed by a Fidelity Checklist

  Using an adapted DPP fidelity checklist, this will examine fidelity of delivery of Family DPP specific sessions; percentage of content delivered by coach during session is reported.

  Up to 12 months

• Total Cost of Program Delivery

  Cost of program delivery (including staffing, materials, wrap-around support) per participant (or for FDPP, per dyad). Calculated separately for DPP and Family DPP (intervention) arm. Total delivery cost of DPP incurred by the delivering center was used for DPP cost/participant- this is calculated as a total cost for a set number of cohorts/participants, divided by number of participants. There is a single value (no variation) for each category of cost that was used to calculate this number, and thus no measure of precision or dispersion can be calculated due to nature of calculating a total cost. For FDPP dyads, additional costs related to FDPP intervention and delivery were included in this calculation.

  12 months (end of intervention)

• Recruitment Rate as Assessed by the Rate of Enrollment Per Week

  Recruitment rate is calculated as the number of eligible participants (adult controls or adult-child dyad intervention arm) consenting and completing enrollment and participating in the trial, divided by period of recruitment (in weeks). This value is calculated separately for intervention arm and concurrent control group. The measure is calculated as # of participants recruited (total)/total number of weeks of recruitment. (For intervention arm, 12 adult-child dyads/22 weeks; for control arm adults: 10 adults/9.5 weeks).

  During recruitment period up to 22 weeks

• Survey Administration Feasibility as Assessed by Mean Time for Administration of Surveys to Participants

  Mean time (minutes) for administration of baseline surveys to adult participant and child participant in the Family DPP (intervention) arm.

  Baseline

• Survey Administration Feasibility as Assessed by Mean Time for Administration of Surveys to Participants

  Mean time (minutes) for administration of surveys to adult participant and child participant at 6 month time point in the Family DPP (intervention) arm.

  6 months

• Survey Administration Feasibility as Assessed by Mean Time for Administration of Surveys to Participants

  Mean time (minutes) for administration of surveys to adult participant and child participant in the Family DPP (intervention) arm.

  12 months

Secondary Outcomes (18)

• Percentage Change in Adult Participant Weight (Kilograms)

  Baseline and 12 months (end of intervention)

• Change in Child Body Mass Index (BMI) Z-score

  Baseline, 6 months and 12 months (end of intervention)

• Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week

  Baseline

• Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week

  6 months

• Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week

  12 months

Study Arms (2)

Diabetes Prevention Program (DPP)

ACTIVE COMPARATOR

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.

Behavioral: National Diabetes Prevention Program Lifestyle Intervention (DPP)

Family Diabetes Prevention Program (Family DPP)

EXPERIMENTAL

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.

Behavioral: Family Diabetes Prevention Program (Family DPP)

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).

Diabetes Prevention Program (DPP)

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.

Family Diabetes Prevention Program (Family DPP)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• Damschroder LJ, Moin T, Datta SK, Reardon CM, Steinle N, Weinreb J, Billington CJ, Maciejewski ML, Yancy WS Jr, Hughes M, Makki F, Richardson CR. Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial. Implement Sci. 2015 May 12;10:68. doi: 10.1186/s13012-015-0250-0.

  PMID: 25962598 BACKGROUND

• Taveras EM, Mitchell K, Gortmaker SL. Parental confidence in making overweight-related behavior changes. Pediatrics. 2009 Jul;124(1):151-8. doi: 10.1542/peds.2008-2892.

  PMID: 19564295 BACKGROUND

• Golan M. Fifteen years of the Family Eating and Activity Habits Questionnaire (FEAHQ): an update and review. Pediatr Obes. 2014 Apr;9(2):92-101. doi: 10.1111/j.2047-6310.2013.00144.x. Epub 2013 Feb 28.

  PMID: 23447444 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity; Diabetes Mellitus, Type 2; Pediatric Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The focus of this trial was to examine measures of feasibility and acceptability related to the Family DPP and delivery of the intervention. The overall small sample size does not allow for definitive measurement of impact on health behaviors and health outcomes.

Results Point of Contact

• Title: Maya Venkataramani MD, MPH
• Organization: Johns Hopkins University Schoo of Medicine

mvenkat2@jh.edu

4109559869

Study Officials

• Maya S Venkataramani, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: July 8, 2022
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: July 8, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-06

Locations

US (1)