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

11. oktober 2017 oppdatert 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

47

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • Group Health Research Institute

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

40 år til 74 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Atferdsmessig: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Program feasibility: Uptake
Tidsramme: 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
Tidsramme: 12 weeks
Measured by the number of participants who return for their 12 week clinic visit
12 weeks
Program feasibility: Attendance
Tidsramme: 24 weeks
Measured by the number of participants who return for their 24 week clinic visit
24 weeks
Program feasibility: Attendance
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fasting glucose
Tidsramme: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
Waist circumference
Tidsramme: Baseline, 12 weeks, 24 weeks
in centimeters
Baseline, 12 weeks, 24 weeks
Blood pressure
Tidsramme: 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
Tidsramme: Baseline, 12 weeks, 24 weeks
Assessed using the Food Frequency Questionnaire
Baseline, 12 weeks, 24 weeks
Weight loss
Tidsramme: Baseline, 12 weeks, 24 weeks, 52 weeks
Weight measured in kilograms
Baseline, 12 weeks, 24 weeks, 52 weeks
Changes in activity
Tidsramme: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured using the Modifiable Activity Questionnaire (MAQ)
Baseline, 12 weeks, 24 weeks, 52 weeks
Glycated hemoglobin (A1C)
Tidsramme: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
Total cholesterol (TC)
Tidsramme: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
High density lipoprotein (HDL)
Tidsramme: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
Low density lipoprotein (LDL)
Tidsramme: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via fasting blood draw.
Baseline, 12 weeks, 24 weeks, 52 weeks
Body Mass Index (BMI)
Tidsramme: Baseline, 12 weeks, 24 weeks, 52 weeks
Baseline, 12 weeks, 24 weeks, 52 weeks
Physical activity level
Tidsramme: Baseline, 12 weeks, 24 weeks, 52 weeks
Participants wore a blinded pedometer for 3 days
Baseline, 12 weeks, 24 weeks, 52 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kaiser Permanente

Etterforskere

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

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. juli 2010

Primær fullføring (Faktiske)

1. oktober 2011

Studiet fullført (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først innsendt

11. september 2012

Først innsendt som oppfylte QC-kriteriene

5. april 2013

Først lagt ut (Anslag)

10. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. oktober 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 184802-16

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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