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Call-2-Health: Preventing Type II Diabetes (C2H)

11 oktober 2017 uppdaterad av: Kaiser Permanente

Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting

It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing to this national trend is the obesity epidemic. Three randomized trials have demonstrated that intensive behavioral interventions can prevent or delay the onset of diabetes. The purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a population-based, telephonic, exercise and weight loss intervention to translate the findings of the Diabetes Prevention Program into practice. The telephonic intervention will be compared to usual care (30 participants in each group). The investigators will deliver the intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24 weeks.

For this planning grant the investigators do not have an overall hypothesis. The investigators' goal is to develop and test whether it is possible to do exercise and weight loss

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

47

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98101
        • Group Health Research Institute

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 74 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Male or female
  • Age 40-74
  • Receives primary care at Group Health Central, Rainier, or Poulsbo clinics in the greater Seattle area
  • Can walk for more than 10 minutes
  • Fasting plasma glucose (FPG) 105-125 mg/dl or glycolated hemoglobin (HbA1C) 5.7-6.4
  • Body Mass Index (BMI) 25 kg/m2 or greater

Exclusion Criteria:

  • Type 1 or 2 diabetes
  • FPG > 125 mg/dl or < 105mg/dl at screening blood draw
  • HbA1C > 6.4 or < 5.7 at screening blood draw
  • Systolic blood pressure > 210 mmHg at the baseline clinic visit
  • Exercise ≥ 30 minutes/day, at least five days a week
  • Current participation in another structured weight loss treatment program or another intervention study
  • Severe concurrent disease
  • Unavailable for the 24-week study period
  • Unable to read or speak English
  • Pregnant or planning to become pregnant.
  • Mentally or legally incapacitated such that informed consent cannot be obtained.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Intervention
Participants assigned to the intervention group worked with the study interventionist over the phone to reduce their risk for developing Diabetes Mellitus, Type 2. The intervention lasted for 24 weeks, with weekly phone calls for the first 12 weeks and 4 maintenance calls over the second 12 weeks. Study measurements were taken at baseline, 12 weeks, 24 weeks, and 52 weeks. After 24 weeks, the investigators randomly divided the intervention group in half. The first group did not receive any more phone calls from the interventionist. The second group continued to receive monthly 20-minute phone calls from the interventionist. At 52 weeks post-baseline participants from both groups had their labs drawn, wore a pedometer for 3 days, and called in with a self-reported weight.
Beteende: Telephonic intervention to prevent Diabetes Mellitus, Type 2
Participants assigned to the intervention group received a total of 16 phone calls from the study interventionist over 24 weeks. The first 12 weeks was the intervention phase and calls were made weekly. The second 12 weeks was the maintenance phase and calls were made every 3 weeks. After 24 weeks, the investigators continued to follow this group for 52 weeks post-randomization, allowing half of the group to continue to receive monthly maintenance calls while the other half received no further calls. The study interventionist used behavior modification techniques to encourage intervention group participants to adopt healthy eating and exercise habits so that improvement might be seen in fasting glucose, glycated hemoglobin (HbA1c), weight, and waist/hip measurements.
Inget ingripande: Control
Participants randomized into this group did not receive any intervention, although they were encouraged to follow-up with their doctor and follow through with usual clinical care.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Program feasibility: Uptake
Tidsram: Baseline
Measured by the number of people who consent to be in the study compared to the number who were eligible
Baseline
Program feasibility: Attendance
Tidsram: 12 weeks
Measured by the number of participants who return for their 12 week clinic visit
12 weeks
Program feasibility: Attendance
Tidsram: 24 weeks
Measured by the number of participants who return for their 24 week clinic visit
24 weeks
Program feasibility: Attendance
Tidsram: 52 weeks
Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)
52 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fasting glucose
Tidsram: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
Waist circumference
Tidsram: Baseline, 12 weeks, 24 weeks
in centimeters
Baseline, 12 weeks, 24 weeks
Blood pressure
Tidsram: Baseline, 12 weeks, 24 weeks
Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)
Baseline, 12 weeks, 24 weeks
Healthy eating habits
Tidsram: Baseline, 12 weeks, 24 weeks
Assessed using the Food Frequency Questionnaire
Baseline, 12 weeks, 24 weeks
Weight loss
Tidsram: Baseline, 12 weeks, 24 weeks, 52 weeks
Weight measured in kilograms
Baseline, 12 weeks, 24 weeks, 52 weeks
Changes in activity
Tidsram: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured using the Modifiable Activity Questionnaire (MAQ)
Baseline, 12 weeks, 24 weeks, 52 weeks
Glycated hemoglobin (A1C)
Tidsram: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
Total cholesterol (TC)
Tidsram: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
High density lipoprotein (HDL)
Tidsram: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
Low density lipoprotein (LDL)
Tidsram: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via fasting blood draw.
Baseline, 12 weeks, 24 weeks, 52 weeks
Body Mass Index (BMI)
Tidsram: Baseline, 12 weeks, 24 weeks, 52 weeks
Baseline, 12 weeks, 24 weeks, 52 weeks
Physical activity level
Tidsram: Baseline, 12 weeks, 24 weeks, 52 weeks
Participants wore a blinded pedometer for 3 days
Baseline, 12 weeks, 24 weeks, 52 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Kaiser Permanente

Utredare

  • Huvudutredare: Katherine Newton, PhD, Group Health Research Institute

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2010

Primärt slutförande (Faktisk)

1 oktober 2011

Avslutad studie (Faktisk)

1 juni 2012

Studieregistreringsdatum

Först inskickad

11 september 2012

Först inskickad som uppfyllde QC-kriterierna

5 april 2013

Första postat (Uppskatta)

10 april 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 oktober 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 oktober 2017

Senast verifierad

1 oktober 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 184802-16

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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