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PreDiabetesNCT05358444

Family Diabetes Prevention Program Pilot Study

A study testing National Diabetes Prevention Program Lifestyle Intervention (DPP) and Family Diabetes Prevention Program (Family DPP) in people with PreDiabetes and Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
What is being tested?
National Diabetes Prevention Program Lifestyle Intervention (DPP) and Family Diabetes Prevention Program (Family DPP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
8 Jul 2022to 19 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • For ADULT participants, inclusion criteria are:
  • Meeting eligibility criteria for the CDC's National Diabetes Prevention Program lifestyle intervention, which are:
  • 18 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).
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  • 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)
  • For CHILD participants, inclusion criteria are:
  • 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.

Who cannot join

  • For ADULT participants, exclusion criteria include
  • 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.
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  • For CHILD participants: exclusion criteria include:
  • 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.
  • The inclusion criteria are:
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205

Other trials in United States

About this study

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.

Being tested
National Diabetes Prevention Program Lifestyle Intervention (DPP), Family Diabetes Prevention Program (Family DPP)
Keywords
Prediabetes, Diabetes Prevention, Child obesity, Child overweight, Obesity, Overweight, Lifestyle Change
Medical subject headings
Prediabetic State, Overweight, Obesity, Diabetes Mellitus, Type 2, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • National Diabetes Prevention Program Lifestyle Intervention (DPP)Behavioural

    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)Behavioural

    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 groups in NCT05358444
Study groupRoleWhat they receive
Diabetes Prevention Program (DPP)Active comparatorAdult 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.
Receives: Behavioral: National Diabetes Prevention Program Lifestyle Intervention (DPP)
Family Diabetes Prevention Program (Family DPP)ExperimentalAdult 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.
Receives: Behavioral: Family Diabetes Prevention Program (Family DPP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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).

    Measured: 12 months

  3. 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).

    Measured: 6 months

  4. 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).

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: Baseline

  7. 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.

    Measured: 6 months

  8. 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.

    Measured: 12 months

  9. 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.

    Measured: 12 months (end of intervention)

  10. 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.

    Measured: Up to 12 months

  11. 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.

    Measured: 12 months (end of intervention)

  12. 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).

    Measured: During recruitment period up to 22 weeks

  13. 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.

    Measured: Baseline

  14. 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.

    Measured: 6 months

  15. 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.

    Measured: 12 months

Secondary outcomes (18)

  1. Percentage Change in Adult Participant Weight (Kilograms)

    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.

    Measured: Baseline and 12 months (end of intervention)

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

    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.

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

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

    Average number of minutes/week of moderate-vigorous physical activity by self report, at baseline.

    Measured: Baseline

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

    Average number of minutes/week of moderate-vigorous physical activity by self report, at 6 months (during core period) among adults for whom data was collected through this time point (this reflects average of values reported Sessions 2 through 18).

    Measured: 6 months

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

    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).

    Measured: 12 months

  6. Percentage of Adult Participants Who Met Physical Activity Achievement

    Whether or not the adult participant met the program goal of an average 150 minutes/week of moderate-vigorous physical activity.

    Measured: 12 months

  7. Change in Adult Participant Dietary Pattern Related to Fruit and Vegetable Intake Frequency

    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.

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

  8. Change in Adult Participant Dietary Pattern Related to Sugary Beverage Intake Frequency

    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.

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

  9. Change in Child Participant Fruit and Vegetable Intake Frequency

    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.

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

  10. Change in Child Participant Sugary Beverage Intake Frequency

    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.

    Measured: Baseline, 6 and 12 months

  11. Change in Child Participant Screen Time

    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.

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

  12. Change in Child Participant Sleep Patterns

    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.

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

  13. Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change

    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.

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

  14. Change in Child Participant Physical Activity Levels

    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.

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

  15. Change in Parenting Self-efficacy for Child Health Behavior Change

    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.

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

  16. Change in Family Eating/Activity Habits and Home Environment

    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.

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

  17. Change in Caregiver Knowledge Regarding Child Health Behaviors

    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.

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

  18. Change in Caregiver Attitudes Regarding Child Health Behaviors

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start8 Jul 2022
  3. Primary completion19 Feb 2024
  4. Study completion19 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05358444
Sponsor's protocol ID
IRB00310219
Other IDs
1K23DK119581-01A1
Status last verified
Jun 2025
First submitted
27 Apr 2022
Last updated
8 Jul 2025
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25962598

  • 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.

    PubMed 19564295

  • 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.

    PubMed 23447444

Questions about this trial

What is this clinical trial studying?

A study testing National Diabetes Prevention Program Lifestyle Intervention (DPP) and Family Diabetes Prevention Program (Family DPP) in people with PreDiabetes and Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adult Participant Attendance in Program as Assessed by Total Number of Required Program Sessions Attended, Core (time frame: 6 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05358444, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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