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Increasing the Effectiveness of the Diabetes Prevention Program

20. mars 2018 oppdatert av: Barbel Knauper, McGill University

Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial

The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in overweight and obese individuals (e.g., 7% average loss of body weight), and thereby reducing the risk of developing weight-related health consequences. One-on-one DPP sessions, however, are costly and the group-delivered DPP version, the Group Lifestyle Balance program (GLB), is less effective (4% average loss of body weight). The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques, namely if-then plans and their mental practice, into the program. The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Please see brief summary.

Studietype

Intervensjonell

Registrering (Faktiske)

172

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1B1
        • McGill University

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

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • men and women
  • ages of 18 and 75
  • overweight or obese (BMI 28-45 kg/m2)
  • sedentary (< 200 min/week of moderate or vigorous exercise)
  • waist circumference of >= 88cm for women and >= 102cm for men

Exclusion Criteria:

  • diabetes (hemoglobin A1c < 7.0%).
  • taking the medication metformin (used for treating pre-diabetes or diabetes)
  • having been pregnant in the past 6 months or planning on becoming pregnant in the next 2 years
  • currently undergoing treatment for cancer
  • using medication that affects body weight (e.g., loop diuretics)
  • being unable to participate in regular moderate physical activity
  • having severe uncontrolled hypertension (> 190/100mm Hg)
  • being unable to communicate in English or French
  • being diagnosed with bulimia nervosa, currently active major depression, or other severe psychiatric disease (including dementia);
  • suffering from a heart attack, stroke, or heart failure within the past 6 months
  • experiencing excessive weight loss (more than 10 pounds or 4.54 kilograms) in the past 3 months
  • currently participating in another weight loss program
  • having had bariatric surgery in the past 2 years or plans on getting it in the near future
  • planning on moving away from Montreal within the next year
  • having another member of one's household enrolled in the program.

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
Eksperimentell: Enriched GLB
This arm aims to increase the effectiveness of the Group Lifestyle Balance (GLB) program by integrating habit formation techniques, namely if-then plans and their mental practice, into the program.
Atferdsmessig: Enriched GLB
Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.
Andre navn:
  • mentale bilder
  • implementeringsintensjoner
  • vekttapsprogram
  • Diabetes Prevention Program
Aktiv komparator: Standard GLB
This arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH.
Atferdsmessig: Standard GLB
This arm is the standard Group Lifestyle Balance program
Andre navn:
  • vekttapsprogram
  • Diabetes Prevention Program

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent body weight loss
Tidsramme: 3 months after beginning of the intervention
The primary outcome will be percent body weight loss from baseline to 3 months after the beginning of the intervention. Weight in kg.
3 months after beginning of the intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent body weight loss
Tidsramme: 12 months
Percent body weight loss 12 months after the beginning of the intervention. Weight in kg.
12 months
Percent body weight loss
Tidsramme: 24 months
Percent body weight loss 24 months after the beginning of the intervention. Weight in kg.
24 months
Personal weight loss goal
Tidsramme: 3 months
Reaching percent body weight loss goal (7% of body weight) from baseline to 3 months after the beginning of the intervention. Weight in kg.
3 months
Personal weight loss goal
Tidsramme: 12 months
Reaching percent body weight loss goal (7% of body weight) 12 months after the beginning of the intervention. Weight in kg.
12 months
Personal weight loss goal
Tidsramme: 24 months
Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention. Weight in kg.
24 months
Personal exercise goal
Tidsramme: 3 months
Reaching exercise goal (150 min/week) from baseline to 3 months after the beginning of the intervention. Sum of minutes over 7 days.
3 months
Personal exercise goal
Tidsramme: 12 months
Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention. Sum of minutes over 7 days.
12 months
Personal exercise goal
Tidsramme: 24 months
Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days.
24 months
Waist circumference
Tidsramme: 3 months
Risk factor for chronic health problems.
3 months
Waist circumference
Tidsramme: 12 months
Risk factor for chronic health problems.
12 months
Waist circumference
Tidsramme: 24 months
Risk factor for chronic health problems.
24 months
Hemoglobin A1c levels
Tidsramme: 3 months
Risk factor for chronic health problems.
3 months
Hemoglobin A1c levels
Tidsramme: 12 months
Risk factor for chronic health problems.
12 months
Hemoglobin A1c levels
Tidsramme: 24 months
Risk factor for chronic health problems.
24 months
Blood pressure
Tidsramme: 3 months
Risk factor for chronic health problems.
3 months
Blood pressure
Tidsramme: 12 months
Risk factor for chronic health problems.
12 months
Blood pressure
Tidsramme: 24 months
Risk factor for chronic health problems.
24 months
Total cholesterol/HDL ratio
Tidsramme: 3 months
Risk factor for chronic health problems.
3 months
Total cholesterol/HDL ratio
Tidsramme: 12 months
Risk factor for chronic health problems.
12 months
Total cholesterol/HDL ratio
Tidsramme: 24 months
Risk factor for chronic health problems.
24 months
Physical activity duration
Tidsramme: 3 months
Total minutes per week.
3 months
Physical activity duration
Tidsramme: 12 months
Total minutes per week.
12 months
Physical activity duration
Tidsramme: 24 months
Total minutes per week.
24 months
Number of steps taken per week
Tidsramme: 3 months
Steps taken per week, recorded using a pedometer.
3 months
Number of steps taken per week
Tidsramme: 12 months
Steps taken per week, recorded using a pedometer.
12 months
Number of steps taken per week
Tidsramme: 24 months
Steps taken per week, recorded using a pedometer.
24 months
Exercise stress test (EST)
Tidsramme: 3 months
3 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-Report Index of Habit Strength
Tidsramme: 3 months
Self-monitoring and behaviors
3 months
Self-Report Index of Habit Strength
Tidsramme: 12 months
Self-monitoring and behaviors
12 months
Self-Report Index of Habit Strength
Tidsramme: 24 months
Self-monitoring and behaviors
24 months
Habit formation indices of weight tracking
Tidsramme: 3 months
Frequency of weight tracking.
3 months
Habit formation indices of weight tracking
Tidsramme: 12 months
Frequency of weight tracking.
12 months
Habit formation indices of weight tracking
Tidsramme: 24 months
Frequency of weight tracking.
24 months
Habit formation indices of physical activity tracking
Tidsramme: 3 months
Frequency of physical activity tracking.
3 months
Habit formation indices of physical activity tracking
Tidsramme: 12 months
Frequency of physical activity tracking.
12 months
Habit formation indices of physical activity tracking
Tidsramme: 24 months
Frequency of physical activity tracking.
24 months
Habit formation indices of fat grams and calorie tracking
Tidsramme: 3 months
Frequency of food tracking.
3 months
Habit formation indices of fat grams and calorie tracking
Tidsramme: 12 months
Frequency of food tracking.
12 months
Habit formation indices of fat grams and calorie tracking
Tidsramme: 24 months
Frequency of food tracking.
24 months

Samarbeidspartnere og etterforskere

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

Sponsor

McGill University

Etterforskere

  • Studieleder: Ilka Lowensteyn, PhD, McGill University
  • Studieleder: Lawrence Joseph, PhD, McGill University
  • Studieleder: Aleksandra Luszczynska, PhD, University of Colorado, Denver
  • Studieleder: Steven Grover, MD, McGill University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Faktiske)

1. april 2013

Primær fullføring (Faktiske)

1. desember 2017

Studiet fullført (Faktiske)

1. desember 2017

Datoer for studieregistrering

Først innsendt

6. desember 2013

Først innsendt som oppfylte QC-kriteriene

6. desember 2013

Først lagt ut (Anslag)

11. desember 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. mars 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MOP-123242

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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