Think Health! A Personal Weight Management Program (Think Health!)
15. august 2016 oppdatert av: University of Pennsylvania
Modeling Effective Obesity Treatment to Reduce Disparities Through Primary Care
Think Health!
A Personal Weight Management Program, or "¡Vive Saludable!
Un programa personalizado de control de peso" aims to improve the treatment of obesity in adults in the general population, by conducting research with men and women recruited from primary care medical practices.
The study has a particular focus on African Americans and Latino.
The design is randomized trial of the effectiveness of two versions of a lifestyle weight loss program called delivered by primary care providers (PCP) and ancillary staff at 5 clinical practice sites to their own patients.
The two versions of the lifestyle weight loss program are called Basic (minimal counseling provided by PCP every four months) and Basic Plus (same PCP counseling plus additional counseling by specially trained ancillary practice staff acting as Lifestyle Coaches (LC), monthly for the first 12 months and then every other month for up to 2 years).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
261
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Penn Family Care at St. Leonard's Court
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Philadelphia, Pennsylvania, Forente stater, 19104
- PennCare- Edward S. Cooper Practice of General Internal Medicine
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Philadelphia, Pennsylvania, Forente stater, 19119
- Greenhouse Internists
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Philadelphia, Pennsylvania, Forente stater, 19120
- Einstein Community Health Associates
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Philadelphia, Pennsylvania, Forente stater, 19120
- Northeast Family Medicine
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Women and men
- Ages 18 to 70 years
- Body mass index > 25 kg/m2 but < 55 kg/m2 or who weigh <400 pounds.
Exclusion Criteria:
- Pregnancy or lactation, since contraindicated for weight loss or affecting weight status
- Weight loss > 10 pounds in the previous 3 months
- Current use of weight loss medications
- Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics)
- Psychiatric disorders including untreated major depression, psychosis, bulimia nervosa, and substance abuse
- Active chemo- or radiation therapy
- Unstable renal, hepatic, or cardiovascular disease, including malignant arrhythmias
- Recent (past 3 months) history of myocardial infarction, stroke, or congestive heart failure
- Participants age < 18 will be excluded because we are only using adult practices and a different type of program would be needed for patients < 18, and age > 70 years will be excluded because our experience has been that a specially tailored program would be needed. As a design consideration, we wanted to decrease the heterogeneity of the program.
- Participants with a BMI > 55 kg/m2 will be excluded because they are likely to require more extensive medical and behavioral care than can be provided in this study.
- More than 1 participant residing in the same household will be excluded to avoid contamination across the treatment conditions.
- Final exclusion criteria will be determined in collaboration with participating primary care providers
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Basic
Basic program participants receive 10-15 minute PCP weight management counseling at approximately four month intervals for up to 24 months and weight management materials.
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Brief 10-15 minute counseling with Primary Care Provider for weight management, Participant binder with eating, physical activity and stress management educational materials, adapted from the Diabetes Prevention Program (DPP)(Knowler et al, 2002; DPP Research Group, 2002), physical activity resource guide, and telephonic health related messages (year 2).
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Eksperimentell: Basic Plus
Half of study participants are randomly assigned to Basic Plus program, where in addition to receiving the same intervention as the Basic program participants, the Basic Plus participants also receive counseling from a lifestyle coach at the primary care provider's office (monthly in year 1 and bimonthly in year 2).
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Brief 10-15 minute counseling with Primary Care Provider for weight management, Participant binder with eating, physical activity and stress management educational materials, adapted from the Diabetes Prevention Program (DPP)(Knowler et al, 2002; DPP Research Group, 2002), physical activity resource guide, and telephonic health related messages (year 2).
15 minute counseling sessions with lifestyle coach, in addition to the Basic Think Health! program intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in body weight, as measured at months 0, 12, 24 (or at final visit).
Tidsramme: Up to 24 months
|
Up to 24 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits.
Tidsramme: Up to 24 months
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Up to 24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Shiriki K Kumanyika, PhD, MPH, University of Pennsylvania
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2006
Primær fullføring (Faktiske)
1. mai 2007
Studiet fullført (Faktiske)
1. mai 2007
Datoer for studieregistrering
Først innsendt
13. august 2009
Først innsendt som oppfylte QC-kriteriene
13. august 2009
Først lagt ut (Anslag)
14. august 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 804917
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