- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01819493
Parents and Children Together Preventing Diabetes (PACT PD) (PACT PD)
Parents and Children Together Preventing Diabetes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest Baptist Health
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Body Mass index (One overweight/obese parent (25 kg/m2 <BMI<40 kg/m2 and one overweight/obese child (at or above the 85th% of age-and gender- specific BMI)
- Parental HbA1c levels (pre-diabetes = 5.7 - 6.4%)
- Parent and their child age 8-10
Exclusion Criteria:
- Clinical history of T2DM
- On glucose-lowering drugs
- Currently participating in a supervised weight loss program
- Pregnant or Breastfeeding
- Has conditions limiting participation in the interventions
- Has undergone weight loss surgery
- Unwilling to accept randomization
- Plans to live outside the general area in the next 6 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Standard Family-Based intervention
Families randomized to the Standard Family-based Intervention will receive three-month family YMCA memberships, one orientation training session, access to available equipment and programming at the YMCA, and receive diabetes educational materials from the "Power to Prevent" curriculum via email.
Based on our previous experience with AA adults, the investigators anticipate that all families will have access to email either at home or at work.
Educational materials will be mailed to families without access to email.
The study will also maintain contact with participants by sending holiday and birthday cards, as well as postcard reminders of scheduled data collection visits.
|
Comparison intervention
|
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Eksperimentel: Lifestyle Intervention
The lifestyle intervention for adults will involve a dietary weight loss program and an increase in caloric expenditure through moderate PA. Parents will be encouraged to decrease caloric intake in a sound manner to produce a total weight loss of 5%. The PA component will be to promote an increase in family home-based activity. Children. The study will promote healthy eating behaviors, rather than restrictive eating plans with caloric restrictions. |
Family-based group lifestyle intervention
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Body Mass Index
Tidsramme: 12 weeks and 16 weeks.
|
The study will assess change in body mass index in both parents and children at 2 post-randomization time points.
We will compare these with baseline BMI.
|
12 weeks and 16 weeks.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Waist Circumference
Tidsramme: 12 weeks and 16 weeks.
|
12 weeks and 16 weeks.
|
|
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Physical activity
Tidsramme: 12 weeks and 16 weeks
|
The study will measure physical activity in parents and children by accelerometry.
|
12 weeks and 16 weeks
|
|
Dietary Intake
Tidsramme: 12 weeks and 16 weeks
|
The study will use BLOCK measures for both children and parents to assess dietary intake.
|
12 weeks and 16 weeks
|
|
Blood Pressure
Tidsramme: 12 weeks and 16 weeks
|
12 weeks and 16 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Bettina Beech, DrPH, Wake Forest University
- Ledende efterforsker: Edward Ip, PhD, Wake Forest University Health Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00021267
- R34DK094108-01A1 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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