Clinical trial NCT05358444: Family Diabetes Prevention Program Pilot Study
Official title: Family Diabetes Prevention Program Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-05-03
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Adult participant attendance in program as assessed by total number of program sessions attended, core
timeFrame: 6 months
measure: Adult participant attendance in program as assessed by total number of program sessions attended, full program
timeFrame: 12 months
measure: Adult participant attendance in program as assessed by percentage of program sessions attended, core
timeFrame: 6 months
measure: Adult participant attendance in program as assessed by percentage of program sessions attended, full program
timeFrame: 12 months
measure: Child participant attendance in Family Diabetes Prevention Program
timeFrame: 12 months
measure: Feasibility of measurement of child-related outcomes as assessed by the percentage of total child participants for whom data are collected
timeFrame: Baseline
measure: Feasibility of measurement of child-related outcomes as assessed by the percentage of total child participants for whom data are collected
timeFrame: 6 months
measure: Feasibility of measurement of child-related outcomes as assessed by the percentage of total child participants for whom data are collected
timeFrame: 12 months
measure: Satisfaction with Family Diabetes Prevention Program as assessed by study team designed questionnaire
timeFrame: 12 months (end of intervention)
measure: Intervention Fidelity as assessed by a fidelity checklist
timeFrame: Up to 12 months
measure: Cost of program delivery
timeFrame: 12 months (end of intervention)
measure: Recruitment rate
timeFrame: During recruitment period, up to 12 weeks
measure: Survey Administration Feasibility as assessed by mean time for administration of surveys to participants
timeFrame: Baseline
measure: Survey Administration Feasibility as assessed by mean time for administration of surveys to participants
timeFrame: 6 months
measure: Survey Administration Feasibility as assessed by mean time for administration of surveys to participants
timeFrame: 12 months
Secondary outcomes:
measure: Change in adult participant weight
timeFrame: Baseline and 12 months (end of intervention)
measure: Change in child Body Mass Index (BMI) z-score
timeFrame: Baseline and 12 months (end of intervention)
measure: Adult participant physical activity as assessed by average duration of activity per week
timeFrame: Baseline
measure: Adult participant physical activity as assessed by average duration of activity per week
timeFrame: 6 months
measure: Adult participant physical activity as assessed by average duration of activity per week
timeFrame: 12 months
measure: Adult participant physical activity achievement
timeFrame: 12 months
measure: Change in adult participant dietary pattern related to fruit and vegetable intake
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in adult participant dietary pattern related to sugary beverage intake
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in child participant fruit and vegetable intake
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in child participant sugary beverage intake
timeFrame: Baseline, 6 and 12 months
measure: Change in child participant screen time
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in child participant sleep patterns
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in adult caregiver perceived self-efficacy for behavioral change
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in child participant physical activity levels
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in parenting self-efficacy for child health behavior change
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in Family Home Health Environment
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in caregiver knowledge regarding child health behaviors
timeFrame: Baseline, 6 months and 12 months (end of intervention)
measure: Change in caregiver attitudes regarding child health behaviors
timeFrame: Baseline, 6 months and 12 months (end of intervention)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Maya S Venkataramani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.