Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-02 @ 5:07 AM
Study NCT ID:
NCT02008435
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing the Effectiveness of the Diabetes Prevention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061217', 'term': 'Weight Reduction Programs'}], 'ancestors': [{'id': 'D006293', 'term': 'Health Promotion'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-Report Index of Habit Strength', 'timeFrame': '3 months', 'description': 'Self-monitoring and behaviors'}, {'measure': 'Self-Report Index of Habit Strength', 'timeFrame': '12 months', 'description': 'Self-monitoring and behaviors'}, {'measure': 'Self-Report Index of Habit Strength', 'timeFrame': '24 months', 'description': 'Self-monitoring and behaviors'}, {'measure': 'Habit formation indices of weight tracking', 'timeFrame': '3 months', 'description': 'Frequency of weight tracking.'}, {'measure': 'Habit formation indices of weight tracking', 'timeFrame': '12 months', 'description': 'Frequency of weight tracking.'}, {'measure': 'Habit formation indices of weight tracking', 'timeFrame': '24 months', 'description': 'Frequency of weight tracking.'}, {'measure': 'Habit formation indices of physical activity tracking', 'timeFrame': '3 months', 'description': 'Frequency of physical activity tracking.'}, {'measure': 'Habit formation indices of physical activity tracking', 'timeFrame': '12 months', 'description': 'Frequency of physical activity tracking.'}, {'measure': 'Habit formation indices of physical activity tracking', 'timeFrame': '24 months', 'description': 'Frequency of physical activity tracking.'}, {'measure': 'Habit formation indices of fat grams and calorie tracking', 'timeFrame': '3 months', 'description': 'Frequency of food tracking.'}, {'measure': 'Habit formation indices of fat grams and calorie tracking', 'timeFrame': '12 months', 'description': 'Frequency of food tracking.'}, {'measure': 'Habit formation indices of fat grams and calorie tracking', 'timeFrame': '24 months', 'description': 'Frequency of food tracking.'}], 'primaryOutcomes': [{'measure': 'Percent body weight loss', 'timeFrame': '3 months after beginning of the intervention', 'description': 'The primary outcome will be percent body weight loss from baseline to 3 months after the beginning of the intervention. Weight in kg.'}], 'secondaryOutcomes': [{'measure': 'Percent body weight loss', 'timeFrame': '12 months', 'description': 'Percent body weight loss 12 months after the beginning of the intervention. Weight in kg.'}, {'measure': 'Percent body weight loss', 'timeFrame': '24 months', 'description': 'Percent body weight loss 24 months after the beginning of the intervention. Weight in kg.'}, {'measure': 'Personal weight loss goal', 'timeFrame': '3 months', 'description': 'Reaching percent body weight loss goal (7% of body weight) from baseline to 3 months after the beginning of the intervention. Weight in kg.'}, {'measure': 'Personal weight loss goal', 'timeFrame': '12 months', 'description': 'Reaching percent body weight loss goal (7% of body weight) 12 months after the beginning of the intervention. Weight in kg.'}, {'measure': 'Personal weight loss goal', 'timeFrame': '24 months', 'description': 'Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention. Weight in kg.'}, {'measure': 'Personal exercise goal', 'timeFrame': '3 months', 'description': 'Reaching exercise goal (150 min/week) from baseline to 3 months after the beginning of the intervention. Sum of minutes over 7 days.'}, {'measure': 'Personal exercise goal', 'timeFrame': '12 months', 'description': 'Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention. Sum of minutes over 7 days.'}, {'measure': 'Personal exercise goal', 'timeFrame': '24 months', 'description': 'Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days.'}, {'measure': 'Waist circumference', 'timeFrame': '3 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Waist circumference', 'timeFrame': '12 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Waist circumference', 'timeFrame': '24 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Hemoglobin A1c levels', 'timeFrame': '3 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Hemoglobin A1c levels', 'timeFrame': '12 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Hemoglobin A1c levels', 'timeFrame': '24 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Blood pressure', 'timeFrame': '3 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Blood pressure', 'timeFrame': '12 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Blood pressure', 'timeFrame': '24 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Total cholesterol/HDL ratio', 'timeFrame': '3 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Total cholesterol/HDL ratio', 'timeFrame': '12 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Total cholesterol/HDL ratio', 'timeFrame': '24 months', 'description': 'Risk factor for chronic health problems.'}, {'measure': 'Physical activity duration', 'timeFrame': '3 months', 'description': 'Total minutes per week.'}, {'measure': 'Physical activity duration', 'timeFrame': '12 months', 'description': 'Total minutes per week.'}, {'measure': 'Physical activity duration', 'timeFrame': '24 months', 'description': 'Total minutes per week.'}, {'measure': 'Number of steps taken per week', 'timeFrame': '3 months', 'description': 'Steps taken per week, recorded using a pedometer.'}, {'measure': 'Number of steps taken per week', 'timeFrame': '12 months', 'description': 'Steps taken per week, recorded using a pedometer.'}, {'measure': 'Number of steps taken per week', 'timeFrame': '24 months', 'description': 'Steps taken per week, recorded using a pedometer.'}, {'measure': 'Exercise stress test (EST)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Group-delivered Diabetes Prevention Program', 'Obesity', 'Overweight', 'Lifestyle change', 'Healthy eating', 'Weight loss', 'Exercise', 'Cognitive-behavioral intervention', 'Implementation intentions', 'Mental imagery', 'Mental practice', 'If-then plans'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '31910891', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29956503', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '24885388', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Please see brief summary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* men and women\n* ages of 18 and 75\n* overweight or obese (BMI 28-45 kg/m2)\n* sedentary (\\< 200 min/week of moderate or vigorous exercise)\n* waist circumference of \\>= 88cm for women and \\>= 102cm for men\n\nExclusion Criteria:\n\n* diabetes (hemoglobin A1c \\< 7.0%).\n* taking the medication metformin (used for treating pre-diabetes or diabetes)\n* having been pregnant in the past 6 months or planning on becoming pregnant in the next 2 years\n* currently undergoing treatment for cancer\n* using medication that affects body weight (e.g., loop diuretics)\n* being unable to participate in regular moderate physical activity\n* having severe uncontrolled hypertension (\\> 190/100mm Hg)\n* being unable to communicate in English or French\n* being diagnosed with bulimia nervosa, currently active major depression, or other severe psychiatric disease (including dementia);\n* suffering from a heart attack, stroke, or heart failure within the past 6 months\n* experiencing excessive weight loss (more than 10 pounds or 4.54 kilograms) in the past 3 months\n* currently participating in another weight loss program\n* having had bariatric surgery in the past 2 years or plans on getting it in the near future\n* planning on moving away from Montreal within the next year\n* having another member of one's household enrolled in the program."}, 'identificationModule': {'nctId': 'NCT02008435', 'briefTitle': 'Increasing the Effectiveness of the Diabetes Prevention Program', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial', 'orgStudyIdInfo': {'id': 'MOP-123242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enriched GLB', 'description': '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.', 'interventionNames': ['Behavioral: Enriched GLB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard GLB', 'description': 'This arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH.', 'interventionNames': ['Behavioral: Standard GLB']}], 'interventions': [{'name': 'Enriched GLB', 'type': 'BEHAVIORAL', 'otherNames': ['Diabetes Prevention Program', 'weight loss program', 'implementation intentions', 'mental imagery'], 'description': 'Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.', 'armGroupLabels': ['Enriched GLB']}, {'name': 'Standard GLB', 'type': 'BEHAVIORAL', 'otherNames': ['Diabetes Prevention Program', 'weight loss program'], 'description': 'This arm is the standard Group Lifestyle Balance program', 'armGroupLabels': ['Standard GLB']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A 1B1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Barbel Knauper, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}, {'name': 'Ilka Lowensteyn, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McGill University'}, {'name': 'Lawrence Joseph, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McGill University'}, {'name': 'Aleksandra Luszczynska, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Steven Grover, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McGill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Barbel Knauper', 'investigatorAffiliation': 'McGill University'}}}}