Finding the Patient's Voice Diabetes Prevention Programs
Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:
- helping youth/families understand the importance of prevention,
- on-going interest and participation, and
- differing personal beliefs.
Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Indiana
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Carmel, Indiana, Förenta staterna, 46032
- Riley Children's Specialties
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University School of Medicine
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Indianapolis, Indiana, Förenta staterna, 46202
- Riley Children's Hospital
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)
At least two of the following risk factors:
- Have been diagnosed with prediabetes;
- Have a family history of T2DM in first- and second-degree relatives;
- Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
- Have conditions associated with insulin resistance; and/or
- Have had gestational diabetes or were exposed to gestational diabetes in utero.
- A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).
Exclusion Criteria:
1. Type 2 diagnosis
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Intervention
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study.
It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
|
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study.
It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
Tidsram: 12 months
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12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hemoglobin A1C
Tidsram: 12 months
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12 months
|
|
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Physical activity
Tidsram: 12 months
|
self-report
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12 months
|
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Quality of life
Tidsram: 12 months
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Pediatric Quality of Life Inventory
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12 months
|
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Intervention group session attendance
Tidsram: 12 months
|
12 months
|
|
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Dietary records
Tidsram: 12 months
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Semi-quantitative food frequency questionniare
|
12 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Tamara Hannon, MD, Indiana University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1510313617
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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