Type 2 Diabetes Self-management Intervention for Low-income Women
A Comprehensive Approach to Type 2 Diabetes Self-management for Low-income Women
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In recent years, the prevalence of diabetes has significantly increased among women and because of the expected fast growth rate of minority populations, the number of women in these groups who will be diagnosed with diabetes is also expected to increase significantly over the coming years. Among women from minority groups diabetes is the fourth leading cause of death while it is the seventh among non-Hispanic White females. Non-compliance to diabetes self-care is a major concern for type 2 diabetic women of racial/ethnic groups because of the existing socio-economic and environmental barriers. Often, these women live in poverty; have less than a high school education as well as language barriers and inadequate health literacy, which further place them at risk for complications, and the daily activities of diabetes self-care are implemented within the context of family responsibilities and patient's priorities.
This study is a 12-month randomized controlled trial designed to compare a lifestyle intervention group (combination group) and a control group (education only group). Participants assigned to either group will receive three group education sessions (baseline, 3 and 6 months) with an emphasis on self-management.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Tennessee
-
Nashville, Tennessee, Forente stater, 37208
- Meharry Medical College
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Low-income women ages 21 and older; With type 2 diabetes ( fasting plasma glucose > 126 mg/dl);
At risk of developing diabetes related complications (treatments goals from The American Diabetes Association Standards of medical care) as defined by:
- HbA1c >8.0 %
- Any of the metabolic clusters such as Pre-prandial plasma glucose > 130 mg/dl; Obesity (BMI >25 kg/m2, or waist circumference >88 cm (>35 in); Hypertension (Systolic >130 and Diastolic > 80 mmHg); Hyperlipidemia (Triglycerides >150 mg/dL; HDL<50 mg/dL; LDL >100 mg/dL)
Exclusion Criteria:
- Participants will be excluded if they are currently pregnant, have conditions (i.e., end stage diagnosis) or behaviors likely to affect conduct of the trial, and unwilling to accept treatment assignment by randomization.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention group
Education and patient liaison combination
|
Group education sessions with Patient liaison using ecological momentary assessment principles
Andre navn:
|
|
Eksperimentell: Control group
Education only
|
Group education sessions at baseline, 3 and 6 months
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
HbA1c
Tidsramme: baseline, 6 and 12 months
|
glycosylated hemoglobin
|
baseline, 6 and 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk factors for co-morbidity and daily self-management behaviors
Tidsramme: baseline, 3, 6, 9 and 12 months
|
|
baseline, 3, 6, 9 and 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sylvie A Akohoue, PhD, Meharry Medical College
Studierekorddatoer
Studer hoveddatoer
Studiestart
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 (Anslag)
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
- 081204AAH231 26
- U54RR026140-01 (U.S. NIH-stipend/kontrakt)
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