Increasing the Effectiveness of the Diabetes Prevention Program
20 mars 2018 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
Please see brief summary.
Studietyp
Interventionell
Inskrivning (Faktisk)
172
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Quebec
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Montreal, Quebec, Kanada, H3A 1B1
- McGill University
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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
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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 |
|---|---|
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Experimentell: 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.
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Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.
Andra namn:
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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.
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This arm is the standard Group Lifestyle Balance program
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent body weight loss
Tidsram: 3 months after beginning of the intervention
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The primary outcome will be percent body weight loss from baseline to 3 months after the beginning of the intervention.
Weight in kg.
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3 months after beginning of the intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percent body weight loss
Tidsram: 12 months
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Percent body weight loss 12 months after the beginning of the intervention.
Weight in kg.
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12 months
|
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Percent body weight loss
Tidsram: 24 months
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Percent body weight loss 24 months after the beginning of the intervention.
Weight in kg.
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24 months
|
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Personal weight loss goal
Tidsram: 3 months
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Reaching percent body weight loss goal (7% of body weight) from baseline to 3 months after the beginning of the intervention.
Weight in kg.
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3 months
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Personal weight loss goal
Tidsram: 12 months
|
Reaching percent body weight loss goal (7% of body weight) 12 months after the beginning of the intervention.
Weight in kg.
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12 months
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Personal weight loss goal
Tidsram: 24 months
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Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention.
Weight in kg.
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24 months
|
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Personal exercise goal
Tidsram: 3 months
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Reaching exercise goal (150 min/week) from baseline to 3 months after the beginning of the intervention.
Sum of minutes over 7 days.
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3 months
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Personal exercise goal
Tidsram: 12 months
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Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention.
Sum of minutes over 7 days.
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12 months
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Personal exercise goal
Tidsram: 24 months
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Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention.
Sum of minutes over 7 days.
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24 months
|
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Waist circumference
Tidsram: 3 months
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Risk factor for chronic health problems.
|
3 months
|
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Waist circumference
Tidsram: 12 months
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Risk factor for chronic health problems.
|
12 months
|
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Waist circumference
Tidsram: 24 months
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Risk factor for chronic health problems.
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24 months
|
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Hemoglobin A1c levels
Tidsram: 3 months
|
Risk factor for chronic health problems.
|
3 months
|
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Hemoglobin A1c levels
Tidsram: 12 months
|
Risk factor for chronic health problems.
|
12 months
|
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Hemoglobin A1c levels
Tidsram: 24 months
|
Risk factor for chronic health problems.
|
24 months
|
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Blood pressure
Tidsram: 3 months
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Risk factor for chronic health problems.
|
3 months
|
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Blood pressure
Tidsram: 12 months
|
Risk factor for chronic health problems.
|
12 months
|
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Blood pressure
Tidsram: 24 months
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Risk factor for chronic health problems.
|
24 months
|
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Total cholesterol/HDL ratio
Tidsram: 3 months
|
Risk factor for chronic health problems.
|
3 months
|
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Total cholesterol/HDL ratio
Tidsram: 12 months
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Risk factor for chronic health problems.
|
12 months
|
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Total cholesterol/HDL ratio
Tidsram: 24 months
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Risk factor for chronic health problems.
|
24 months
|
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Physical activity duration
Tidsram: 3 months
|
Total minutes per week.
|
3 months
|
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Physical activity duration
Tidsram: 12 months
|
Total minutes per week.
|
12 months
|
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Physical activity duration
Tidsram: 24 months
|
Total minutes per week.
|
24 months
|
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Number of steps taken per week
Tidsram: 3 months
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Steps taken per week, recorded using a pedometer.
|
3 months
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Number of steps taken per week
Tidsram: 12 months
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Steps taken per week, recorded using a pedometer.
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12 months
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Number of steps taken per week
Tidsram: 24 months
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Steps taken per week, recorded using a pedometer.
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24 months
|
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Exercise stress test (EST)
Tidsram: 3 months
|
3 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Self-Report Index of Habit Strength
Tidsram: 3 months
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Self-monitoring and behaviors
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3 months
|
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Self-Report Index of Habit Strength
Tidsram: 12 months
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Self-monitoring and behaviors
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12 months
|
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Self-Report Index of Habit Strength
Tidsram: 24 months
|
Self-monitoring and behaviors
|
24 months
|
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Habit formation indices of weight tracking
Tidsram: 3 months
|
Frequency of weight tracking.
|
3 months
|
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Habit formation indices of weight tracking
Tidsram: 12 months
|
Frequency of weight tracking.
|
12 months
|
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Habit formation indices of weight tracking
Tidsram: 24 months
|
Frequency of weight tracking.
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24 months
|
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Habit formation indices of physical activity tracking
Tidsram: 3 months
|
Frequency of physical activity tracking.
|
3 months
|
|
Habit formation indices of physical activity tracking
Tidsram: 12 months
|
Frequency of physical activity tracking.
|
12 months
|
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Habit formation indices of physical activity tracking
Tidsram: 24 months
|
Frequency of physical activity tracking.
|
24 months
|
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Habit formation indices of fat grams and calorie tracking
Tidsram: 3 months
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Frequency of food tracking.
|
3 months
|
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Habit formation indices of fat grams and calorie tracking
Tidsram: 12 months
|
Frequency of food tracking.
|
12 months
|
|
Habit formation indices of fat grams and calorie tracking
Tidsram: 24 months
|
Frequency of food tracking.
|
24 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Ilka Lowensteyn, PhD, McGill University
- Studierektor: Lawrence Joseph, PhD, McGill University
- Studierektor: Aleksandra Luszczynska, PhD, University of Colorado, Denver
- Studierektor: Steven Grover, MD, McGill University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Knauper B, Shireen H, Carriere K, Frayn M, Ivanova E, Xu Z, Lowensteyn I, Sadikaj G, Luszczynska A, Grover S; McGill CHIP Healthy Weight Program Investigators. The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial. Trials. 2020 Jan 7;21(1):40. doi: 10.1186/s13063-019-4014-z.
- Knauper B, Carriere K, Frayn M, Ivanova E, Xu Z, Ames-Bull A, Islam F, Lowensteyn I, Sadikaj G, Luszczynska A, Grover S; McGill CHIP Healthy Weight Program Investigators. The Effects of If-Then Plans on Weight Loss: Results of the McGill CHIP Healthy Weight Program Randomized Controlled Trial. Obesity (Silver Spring). 2018 Aug;26(8):1285-1295. doi: 10.1002/oby.22226. Epub 2018 Jun 28.
- Knauper B, Ivanova E, Xu Z, Chamandy M, Lowensteyn I, Joseph L, Luszczynska A, Grover S. Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program. BMC Public Health. 2014 May 18;14:470. doi: 10.1186/1471-2458-14-470.
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 (Faktisk)
1 april 2013
Primärt slutförande (Faktisk)
1 december 2017
Avslutad studie (Faktisk)
1 december 2017
Studieregistreringsdatum
Först inskickad
6 december 2013
Först inskickad som uppfyllde QC-kriterierna
6 december 2013
Första postat (Uppskatta)
11 december 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 mars 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 mars 2018
Senast verifierad
1 mars 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MOP-123242
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 .