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Increasing the Effectiveness of the Diabetes Prevention Program

20. marts 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Please see brief summary.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

172

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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
Eksperimentel: 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.
Adfærdsmæssigt: Enriched GLB
Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.
Andre navne:
  • mentale billedsprog
  • implementeringsintentioner
  • vægttabsprogram
  • 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.
Adfærdsmæssigt: Standard GLB
This arm is the standard Group Lifestyle Balance program
Andre navne:
  • vægttabsprogram
  • Diabetes Prevention Program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

McGill University

Efterforskere

  • 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. april 2013

Primær færdiggørelse (Faktiske)

1. december 2017

Studieafslutning (Faktiske)

1. december 2017

Datoer for studieregistrering

Først indsendt

6. december 2013

Først indsendt, der opfyldte QC-kriterier

6. december 2013

Først opslået (Skøn)

11. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MOP-123242

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 .

Kliniske forsøg med Enriched GLB

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Dominican Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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