- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01220089
Adaptation of the Diabetes Prevention Program for Primary Care
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will be a randomized trial of a weight control intervention, with participants recruited primarily from primary care practices at the University of Colorado. Study treatment will be delivered at the Center for Human Nutrition, an inter-disciplinary research clinic which is part of the University of Colorado School of Medicine. If needed, administrative study visits, such as for informed consent and for completion of questionnaires, may take place at offices in the Division of General Internal Medicine. Up to 200 patients will be enrolled, of which up to 125 will be provided with 6 months of high-intensity weight loss counseling. During the first 6 months, each participant will be seen for 12 counseling visits. These visits will take place at weeks 1, 2, 3, 4, 6, 8, 10, 12, 15, 18, 21, and 24. We estimate that between 10% and 20% of these patients will drop out prior to 6 months. After the first 6 months, the remaining participants will be randomly assigned to a treatment condition: Standard Maintenance or Intensified Maintenance. During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance, while those in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach").
All participants will use portion-controlled foods to replace 2 meals per day during the first 6 months of treatment and to replace 1 meal per day during months 7 to 18. Participants will purchase their own portion-controlled foods, although in-kind contributions from private industry will be sought to offset participants' food costs. The study consent form will explicitly describe estimated food costs for study participants. The cost of the meal plan, a "partial meal replacement" diet (replacement of 2 out of 3 meals per day) is not expected to increase food costs. Many participants should observe a decrease in food costs while following the meal plan.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Colorado
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Denver, Colorado, Forenede Stater, 80220
- Center for Human Nutrition
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 18 to 79
- Able to give informed consent
- Able to keep a food record for 7 days prior to study entry and to complete 2 screening visits and a blood draw prior to enrollment
- Willing to attend all counseling sessions, to complete study-related assessments, and to be randomized to a treatment condition after 6 months of treatment
- Has a regular primary care physician (if referred from outside the University of Colorado system)
- Body mass index (BMI) ≥ 30 kg/m2 and < 50 kg/m2
- Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the following:
- Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including type 2 diabetes); individuals taking medications for diabetes qualify automatically
- Elevated blood pressure (≥ 130/85), including hypertension (≥ 140/90); individuals taking anti-hypertensive medication qualify automatically
- Hyperlipidemia/dyslipidemia, including any of the following: hypertriglyceridemia (TG ≥ 150); low HDL cholesterol (< 40 for men, < 50 for women); or taking lipid-lowering medications
- Obstructive sleep apnea -
Exclusion Criteria:
- Medical conditions in which significant weight loss is normally contraindicated (e.g. pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes, Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe internal organ disease); exceptions may be made if a referring physician documents that it is safe and appropriate for the individual to lose weight
- Treated for cancer within the past 5 years, except for basal cell or squamous cell skin cancer; exceptions may be made with written permission from a physician
- Myocardial infarction or stroke within the past 6 months
- Poorly controlled hypertension (≥ 160/100); may be re-screened when controlled
- Poorly controlled diabetes (hemoglobin A1c ≥ 10.0); may be re-screened when controlled
- Weight gain or loss of ≥ 5% of weight in the past 6 months; patients who have not been weight stable may be re-screened
- Chronic use of corticosteroids or second-generation antipsychotic medications (exceptions may be made for individuals using these medications who have been weight stable for 6 months)
- Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g., poorly controlled schizophrenia, active substance abuse)
- Untreated major depression (PHQ-9 score ≥ 20)
- Pregnant or trying to become pregnant
- Social situation precluding participation in a research study (e.g., need to care for a small child or an elderly parent)
- Prior or planned bariatric surgery
- Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment
Studieplan
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 |
|---|---|
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Aktiv komparator: Standard maintenance
During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance.
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Participants will receive written materials in months 7-18
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Aktiv komparator: Intensified Maintenance
During months 7 to 18, individuals in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach").
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Participants will continue with in-person counseling visits in months 7-18
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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weight change
Tidsramme: Weeks 1-4, 6, 8, 10, 12, 15, 18, 21, 24 & 72
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Weeks 1-4, 6, 8, 10, 12, 15, 18, 21, 24 & 72
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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change in glucose
Tidsramme: baseline, 6 months & 18 months
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baseline, 6 months & 18 months
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change in blood pressure
Tidsramme: baseline, 6 months & 18 months
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baseline, 6 months & 18 months
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change in waist circumference
Tidsramme: baseline, 6 months & 18 months
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baseline, 6 months & 18 months
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change in lipids
Tidsramme: baseline, 6 months & 18 months
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baseline, 6 months & 18 months
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change in health-related quality of life
Tidsramme: baseline & 18 months
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baseline & 18 months
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cost effectiveness
Tidsramme: 18 months
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18 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Adam G Tsai, MD, MSCE, University of Colorado, Denver
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10-0719
- K24DK065018 (U.S. NIH-bevilling/kontrakt)
- 10SDG210292 (Anden identifikator)
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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