Who is sponsoring NCT05358444?

NCT05358444 is sponsored by Johns Hopkins University.

What condition does NCT05358444 study?

NCT05358444 studies PreDiabetes, Overweight and Obesity, Type 2 Diabetes, Overweight, Childhood, Obesity, Childhood, Lifestyle, Healthy.

Is NCT05358444 still recruiting?

NCT05358444 is currently completed. Last updated 8 July 2025.

Are results published for NCT05358444?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-08 · How we verify

NCT05358444

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Family Diabetes Prevention Program Pilot Study

Completed NA Results posted Last updated 8 July 2025

What this trial tests

NA trial testing National Diabetes Prevention Program Lifestyle Intervention (DPP) in PreDiabetes in 34 participants. Completed in 19 February 2024.

Timeline

8 July 2022

Primary endpoint
19 February 2024

19 February 2024

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	34
Start date	8 July 2022
Primary completion	19 February 2024
Estimated completion	19 February 2024
Sites	1 location across United States

Drugs / interventions tested

National Diabetes Prevention Program Lifestyle Intervention (DPP)
Family Diabetes Prevention Program (Family DPP)

Conditions studied

PreDiabetes — all drugs for PreDiabetes →
Overweight and Obesity — all drugs for Overweight and Obesity →
Type 2 Diabetes — all drugs for Type 2 Diabetes →
Overweight, Childhood — all drugs for Overweight, Childhood →

Sponsor

Johns Hopkins University

Who can join

5 and older, any sex, with PreDiabetes or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

All Core Sessions

Group	Value	95% CI
Diabetes Prevention Program (DPP)	17.6	± 0.22
Family Diabetes Prevention Program (Family DPP)	14.8	± 1.8

DPP only core sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	13.5	± 1.6

Family DPP child-focused sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	1.4	± 0.24

Adult Participant Attendance in Program as Assessed by Total Number of Program Sessions Attended, Full Program Primary · 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).

All required sessions

Group	Value	95% CI
Diabetes Prevention Program (DPP)	25.2	± 0.99
Family Diabetes Prevention Program (Family DPP)	25.1	± 3.9

All required DPP sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	18.8	± 2.8

All required Family DPP sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	6.3	± 1.2

All required child-focused Family DPP sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	4.9	± 1.0

Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Core Primary · 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).

Percentage of all required core sessions

Group	Value	95% CI
Diabetes Prevention Program (DPP)	97.8	95.0 – 100.0
Family Diabetes Prevention Program (Family DPP)	74.1	53.6 – 94.6

Percentage of all required core DPP sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	74.7	54.5 – 95.0

Percentage of required core Family DPP sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	68.2	41.0 – 95.4

Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Full Program Primary · 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).

Percentage of all required sessions

Group	Value	95% CI
Diabetes Prevention Program (DPP)	87.8	80.2 – 95.4
Family Diabetes Prevention Program (Family DPP)	64.3	42.1 – 86.6

Percentage of all required DPP sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	64.8	43.4 – 86.4

Percentage of all required FDPP sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	62.8	35.2 – 90.3

Percentage of all child-focused required FDPP sessions

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	61.4	32.4 – 90.3

Child Participant Attendance in Family Diabetes Prevention Program Primary · 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.

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	44.3	20.5 – 68.2

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

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.

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	100

Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected Primary · 6 months

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.

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	81.2

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

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	72.7

Satisfaction With Family Diabetes Prevention Program as Assessed by Study Team Designed Questionnaire Primary · 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.

"I would recommend the Family DPP to others"

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	3.88	± 0.13

"I believe the Family DPP sessions were helpful in helping me address children's health behaviors"

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	3.75	± 0.16

"I believe the Family DPP sessions were helpful in helping me address my own health behaviors"

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	3.75	± 0.16

Intervention Fidelity as Assessed by a Fidelity Checklist Primary · 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.

Group	Value	95% CI
Family Diabetes Prevention Program (Family DPP)	91.4	86.9 – 95.8

Total Cost of Program Delivery Primary · 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

Group	Value	95% CI
Diabetes Prevention Program (DPP)	1022.95
Family Diabetes Prevention Program (Family DPP)	1288.97

Recruitment Rate as Assessed by the Rate of Enrollment Per Week Primary · 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).

Group	Value	95% CI
Diabetes Prevention Program (DPP)	1.05
Family Diabetes Prevention Program (Family DPP)	0.55

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Diabetes Prevention Program (DPP)

Serious: 1/10 (10%)

Deaths: 0/10

Family Diabetes Prevention Program (Family DPP)

Serious: 3/24 (13%)

Deaths: 0/24

Serious adverse events (4 terms)

Reaction	System	Diabetes Prevention Progra…	Family Diabetes Prevention…
Musculoskeletal injury	Musculoskeletal and connective tissue disorders	—	—
Hospitalization	Gastrointestinal disorders	—	—
Musculoskeletal injury	Musculoskeletal and connective tissue disorders	—	—
Elective surgery	Surgical and medical procedures	—	—

Most-reported serious reactions: Musculoskeletal injury, Hospitalization, Musculoskeletal injury, Elective surgery.

Data from ClinicalTrials.gov NCT05358444 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Interventions to prevent obesity in children aged 5 to 11 years old.
Spiga F, Davies AL, Tomlinson E, Moore TH, et al · · 2024 · cited 40× · PMID 38763517 · DOI 10.1002/14651858.cd015328.pub2

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05358444 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 8 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05358444.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing