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Primary Care Community Partnerships to Prevent Diabetes (RAPID)

27. marts 2018 opdateret af: Ronald Ackermann, Northwestern University
The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Randomized controlled trials have shown that modest lifestyle changes can prevent or delay the onset of diabetes in adults with pre-diabetes. Unfortunately, despite the increasing prevalence of pre-diabetes and diabetes in all facets of the population, intervention programs needed to achieve these goals are costly and remain unavailable in most clinical settings. Over the past 3 years, we have demonstrated the feasibility of training community instructors to deliver a group-based adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention. In this pilot research, this new delivery model achieves a level of weight reduction that was associated with diabetes prevention and improved cardiometabolic risk factor control in the DPP. This new, large-scale randomized effectiveness trial is designed to evaluate the costs and effectiveness of a partnered approach to identify adults with pre-diabetes in primary care settings, deliver brief advice for diabetes prevention, and provide access to a group-based adaptation of the DPP lifestyle intervention offered by the community. This study will compare costs and outcomes to a standard care, brief clinical counseling approach delivered by Registered Dietitians.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

509

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University

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

16 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 18 years of age or older
  • Body-mass index of 24 kg/m2 or greater
  • Fasting Blood Glucose 100 - 125 mg/dl, OR 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl

Exclusion Criteria:

  • Cancer requiring treatment in the past 5 years
  • Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
  • Heart attack, stroke, or transient ischemic attack in the past 6 months,
  • Chronic obstructive airways disease or asthma requiring home oxygen
  • Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to <5 years
  • Pregnancy
  • Existing diagnosis of diabetes mellitus
  • Fasting capillary blood glucose > 125 mg/dl
  • 2-hour post-challenge capillary blood glucose > 199 mg/dl
  • History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes
  • Self-report of a medication known to lead to hyperglycemia (oral steroids, antipsychotics, anti-epileptics)
  • Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Dietitian Counseling Alone
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone
Adfærdsmæssigt: Dietitian Counseling Alone
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
Eksperimentel: Dietitian Plus Community Group Lifestyle
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based diabetes prevention lifestyle intervention offered by the community. Dietitian Counseling Plus Community Group Lifestyle Intervention.
Adfærdsmæssigt: Dietitian Plus Community Group Lifestyle
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
% Change in Body Weight
Tidsramme: 12 months
(weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
% Change in Blood Total Cholesterol
Tidsramme: 12 months
(total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline)
12 months
% Change in glycosylated hemoglobin
Tidsramme: 12 months
(HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline)
12 months
% Change in Blood Pressures
Tidsramme: 12 months
(mean SBP at 12 months - mean SBP at baseline) / (mean SBP at baseline); (mean DBP at 12 months - mean DBP at baseline) / (mean DBP at baseline)
12 months
Changes in Dietary Composition
Tidsramme: 12 months
NHIS Multifactor Screener: Change in % dietary kcal from fat at 12 months (est % dietary Kcal from fat at 12 months - est % dietary Kcal from fat at baseline)
12 months
Changes in Physical Activity
Tidsramme: 12 months
Paffenbarger PAQ: (Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at 12 months - Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at Baseline)
12 months
Incremental Costs
Tidsramme: 12 months
12 months
Incremental Health State Utility
Tidsramme: 12 months
12 months
% Change in Body Weight
Tidsramme: 6 months
(weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline)
6 months
% Change in Body Weight
Tidsramme: 24 months
(weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline)
24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northwestern University

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Ronald T Ackermann, MD, MPH, Northwestern University School Of Medicine

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. april 2008

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

10. april 2008

Først indsendt, der opfyldte QC-kriterier

10. april 2008

Først opslået (Skøn)

11. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. marts 2018

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R18DK079855 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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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Placeringer

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