Family Diabetes Prevention Program Pilot Study

Not Applicable

Completed

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

Registration Number: NCT05358444

Lead Sponsor: Johns Hopkins University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adult Participant Attendance in Program as Assessed by Total Number of Required Program Sessions Attended, Core	6 months	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.
Adult Participant Attendance in Program as Assessed by Total Number of Program Sessions Attended, Full Program	12 months	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).
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Core	6 months	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).
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Full Program	12 months	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).
Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected	12 months	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.
Child Participant Attendance in Family Diabetes Prevention Program	12 months	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.
Satisfaction With Family Diabetes Prevention Program as Assessed by Study Team Designed Questionnaire	12 months (end of intervention)	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.
Intervention Fidelity as Assessed by a Fidelity Checklist	Up to 12 months	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.
Total Cost of Program Delivery	12 months (end of intervention)	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.
Recruitment Rate as Assessed by the Rate of Enrollment Per Week	During recruitment period up to 22 weeks	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).
Survey Administration Feasibility as Assessed by Mean Time for Administration of Surveys to Participants	12 months	Mean time (minutes) for administration of surveys to adult participant and child participant in the Family DPP (intervention) arm.

Secondary Outcome Measures

Name	Time	Method
Percentage Change in Adult Participant Weight (Kilograms)	Baseline and 12 months (end of intervention)	Percentage change in weight (kilograms) from baseline to end of program (Self-report from home weight may be used depending on program delivery modality). Calculated for adults who are considered "DPP completers" (requires having been in DPP at least 9 months and also attending at least 8 sessions in core period) per the DPP specific definition.
Change in Child Body Mass Index (BMI) Z-score	Baseline, 6 months and 12 months (end of intervention)	Change in Centers for Disease Control and Prevention's extended Body Mass Index (BMI) z-score at end of program (12 months) compared to baseline and 6 months, from BMI calculated from weight and height measurements during program in the Family DPP (intervention) arm. (Z-score of 0 indicates population mean value). Calculated for all children and among subgroup of children with overweight or obese weight status at baseline.
Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week	12 months	Average number of minutes/week of moderate-vigorous physical activity by self report, by 12 months/end of program, among adults considered DPP completers (this reflects average of values reported Sessions 2 through 29).
Percentage of Adult Participants Who Met Physical Activity Achievement	12 months	Whether or not the adult participant met the program goal of an average 150 minutes/week of moderate-vigorous physical activity.
Change in Adult Participant Dietary Pattern Related to Fruit and Vegetable Intake Frequency	Baseline, 6 months and 12 months (end of intervention)	Questions from the Behavioral Risk Factor Surveillance System (BRFSS) 2017 modules on fruit, vegetable and fruit juice intake as assessed by participant recall (for 1 week period), which quantify frequency of intake of these food items over 1 week-recall period; changes in intake patterns from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.
Change in Adult Participant Dietary Pattern Related to Sugary Beverage Intake Frequency	Baseline, 6 months and 12 months (end of intervention)	Questions from the BRFSS on sugary beverage intake, as assessed by participant recall (for 1 week period), which quantify frequency of intake of sugary beverages over 1 week-recall period; changes in intake patterns from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.
Change in Child Participant Fruit and Vegetable Intake Frequency	Baseline, 6 months and 12 months (end of intervention)	Questions from the YRBS 2017 modules on fruit and vegetable intake, which quantify intake of these food items over a 7-day period; questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in intake patterns from baseline will be assessed.
Change in Child Participant Sugary Beverage Intake Frequency	Baseline, 6 and 12 months	Questions from the Youth Risk Behavioral Surveillance System (YRBSS) on sugary beverage intake frequency over a 7-day period; questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in intake patterns from baseline, at 6 and 12 months, will be assessed.
Change in Child Participant Screen Time	Baseline, 6 months and 12 months (end of intervention)	Adaptation of questions from YRBSS regarding average number of hours of screen time/day, asked weekday or weekend over past 7 days. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. (Options given of less than 1 hour, coded as 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 5 hours or more (coded as 5 hours). Changes in number of hours of screen time from baseline, at 6 and 12 months, will be assessed for children in the Family DPP (intervention) arm.
Change in Child Participant Sleep Patterns	Baseline, 6 months and 12 months (end of intervention)	Adaptation of questions from YRBSS regarding average number of hours of sleep per night on weekdays, over last week. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes will be assessed, at 6 and 12 months.
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change	Baseline, 6 months and 12 months (end of intervention)	Questionnaire exploring confidence in achieving behavioral goals related to physical activity, sleep and dietary modifications, using a Likert scale with options from 1 to 5, higher scores indicating higher perceived self-efficacy). Mean change in self-efficacy for each item from baseline (to 6 months and 12 months) will be assessed for adults in the Family DPP (intervention) arm.
Change in Child Participant Physical Activity Levels	Baseline, 6 months and 12 months (end of intervention)	Adaptations of questions from YRBS regarding number of days meeting physical activity goal/week. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in activity patterns from baseline, including whether meeting daily physical activity guidelines, will be assessed for children in the Family DPP (intervention) arm.
Change in Parenting Self-efficacy for Child Health Behavior Change	Baseline, 6 months and 12 months (end of intervention)	Questionnaire exploring adult caregiver confidence in supporting child to achieve behavioral goals related to physical activity, sleep, screen time and diet, using a Likert scale from 1 to 5 with higher scores indicating higher perceived self-efficacy). Mean change in parenting self-efficacy overall and for each item from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.
Change in Family Eating/Activity Habits and Home Environment	Baseline, 6 months and 12 months (end of intervention)	The Family Eating and Activity Habits Questionnaire-Revised (FEAHQ-R) is a 32-item, self-report instrument; score range 0-128 with likert scale options 0-4. It is a clinical tool that captures family member eating and activity habits and also factors related with obesity in the overall home environment for children and caregivers. A higher score is associated with less favorable or appropriate patterns. Mean changes in scores from baseline, at 6 and 12 months, will be assessed in the Family DPP (intervention) arm.
Change in Caregiver Knowledge Regarding Child Health Behaviors	Baseline, 6 months and 12 months (end of intervention)	Questionnaire examining knowledge or awareness of age-specific pediatric guidelines for sleep, dietary intake, screen time and physical activity. 4 total questions, with percentage of questions answered correctly ranging from 0% to 100%. Mean change in the percentage of questions answered correctly from baseline, will be examined for adults in the Family DPP (intervention) arm.
Change in Caregiver Attitudes Regarding Child Health Behaviors	Baseline, 6 months and 12 months (end of intervention)	Questionnaire examining caregiver beliefs and attitudes towards age-specific guidelines for sleep, dietary intake, screen time and physical activity, using a Likert scale for extent to which respondent agrees or disagrees with statements (Likert Scale Options of 1-4: 1-Strongly Disagree to 4-Strongly Agree). Higher score indicates higher agreement with the statement. Mean change in score for each from baseline examined for adults in the Family DPP (intervention) arm.

Trial Locations

Locations (1): Johns Hopkins University School of Medicine
🇺🇸
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States