NCT05358444Befejeződött
Family Diabetes Prevention Program Pilot Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 8.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 34 (tényleges)
- Első benyújtás
- 2022. ápr. 27.
- Kezdés
- 2022. júl. 8.
- Elsődleges befejezés
- 2024. febr. 19.
- Fő szponzor
- Johns Hopkins University
- Betegségek
- Elhízás, 2-es típusú cukorbetegség
- NCT-szám
- NCT05358444
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 34
- 2022. júl. 8. és az elsődleges befejezés (2024. febr. 19.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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.
Más betegség
- 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.
Életkor
- 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
Kiket keres a vizsgálat
- 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).
- 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.
Életkor a regiszterben: 5 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Johns Hopkins University School Of Medicine | Baltimore | Egyesült Államok | Ismeretlen állapot |
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