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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Indiana
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Carmel, Indiana, Forente stater, 46032
- Riley Children's Specialties
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Indianapolis, Indiana, Forente stater, 46202
- Indiana University School of Medicine
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Indianapolis, Indiana, Forente stater, 46202
- Riley Children's Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
Tidsramme: 12 months
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hemoglobin A1C
Tidsramme: 12 months
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12 months
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Physical activity
Tidsramme: 12 months
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self-report
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12 months
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Quality of life
Tidsramme: 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
Tidsramme: 12 months
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12 months
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Dietary records
Tidsramme: 12 months
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Semi-quantitative food frequency questionniare
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12 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Tamara Hannon, MD, Indiana University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1510313617
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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