- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00959608
Think Health! A Personal Weight Management Program (Think Health!)
15. august 2016 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
261
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Penn Family Care at St. Leonard's Court
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- PennCare- Edward S. Cooper Practice of General Internal Medicine
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Philadelphia, Pennsylvania, Forenede Stater, 19119
- Greenhouse Internists
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Philadelphia, Pennsylvania, Forenede Stater, 19120
- Einstein Community Health Associates
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Philadelphia, Pennsylvania, Forenede Stater, 19120
- Northeast Family Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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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Eksperimentel: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in body weight, as measured at months 0, 12, 24 (or at final visit).
Tidsramme: Up to 24 months
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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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Shiriki K Kumanyika, PhD, MPH, University of Pennsylvania
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2006
Primær færdiggørelse (Faktiske)
1. maj 2007
Studieafslutning (Faktiske)
1. maj 2007
Datoer for studieregistrering
Først indsendt
13. august 2009
Først indsendt, der opfyldte QC-kriterier
13. august 2009
Først opslået (Skøn)
14. august 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 804917
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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