Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-01 @ 7:47 PM
Study NCT ID:
NCT01579292
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2012-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mobile Based Diabetes Prevention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-16', 'studyFirstSubmitDate': '2012-04-15', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight (kg)', 'timeFrame': '5 months'}, {'measure': 'Body mass index', 'timeFrame': '5 months'}], 'secondaryOutcomes': [{'measure': 'Physical activity measured by Omron Active Style Pro HJA-350IT pedometer', 'timeFrame': '5 months'}, {'measure': 'Total daily calories (kcal)', 'timeFrame': '5 months'}, {'measure': 'Daily calories from fat (kcal)', 'timeFrame': '5 months'}, {'measure': 'Fasting plasma glucose', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sedentary Lifestyle', 'Physical Activity', 'Pre-Diabetic']}, 'descriptionModule': {'briefSummary': 'The goals of the study are to:\n\n1. Assess effect sizes of our mDPP intervention on weight loss, physical activity, dietary intake, and fasting plasma glucose (FPG) levels from baseline to 5 months as compared to a control group.\n2. To explore the association between low heath-literacy levels at baseline and adherence to mobile phone usage.\n3. To conduct process evaluation to gain insights into patient compliance to the mobile intervention, including usage barriers and acceptability of our mDPP, at 1 and 5 months using a semi-structured interview method.', 'detailedDescription': 'The prevalence of type 2 diabetes (T2DM) continues to rise at an alarming rate in the United States. A greater risk of diabetes is observed for ethnic/racial minority and lower socioeconomic status (SES)groups as compared to Caucasians of similar ages. Several clinical trials have tested intensive lifestyle interventions or pharmacologic agents in preventing or delaying T2DM in adults at risk. These trials (e.g.the Diabetes Prevention Program) consistently show impressive diabetes risk reductions using lifestyle interventions, such as relatively modest amounts of weight loss and exercise. However these programs have been expensive to implement and sustain over time in clinical settings or communities.\n\nMobile technologies are ideal platforms to deliver and disseminate such lifestyle modification programs to a much broader ethnic/racial minority population, making them more cost effective. Today, 87% of adults in the U.S. own a mobile phone. In particular, usage of non-voice services (such as text messaging or mobile internet) in African-Americans and non-white Hispanics is significantly higher than their Caucasian counterparts. In contrast, ethnic /racial minority populations are much less likely to own a computer at home compared to their Caucasian counterparts. Given the rapid diffusion of mobile technologies in ethnic/racial minority populations, we need to understand how to apply mobile persuasive technologies to such lifestyle modification programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary lifestyle at work and/or during leisure time\n* Intend to be physically active\n* Are over 25 years of age\n* Access to a home telephone or a mobile phone\n* Speak and read English\n* Are not physically active\n* Have no disabilities that limit physical activity\n* Have high blood sugar (fasting blood sugar 100-125) but do not have diabetes\n\nExclusion Criteria:\n\n* Known medical conditions or other physical problems that need special attention in an exercise program\n* Plan a trip abroad during the first 5 months of the study period.\n* Pregnant/Delivered a baby during the last 6 months\n* Known severe hearing or speech problem\n* Currently participate in lifestyle modification programs or research studies that may potentially confound the results of the study\n* History of gastric bypass surgery or future plans for gastric bypass surgery in the next 5 months\n* Already taking medication for diabetes\n* Recovery from addiction\n* Known eating disorders\n* Bmi over 25 if non-Asian or over 23 if Asian'}, 'identificationModule': {'nctId': 'NCT01579292', 'briefTitle': 'A Mobile Based Diabetes Prevention Program', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)', 'orgStudyIdInfo': {'id': '1107481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Activity and Diet Intervention', 'description': '5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer', 'interventionNames': ['Behavioral: Mobile phone based physical activity with intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pedometer only', 'description': 'Pedometer only', 'interventionNames': ['Behavioral: Pedometer Only']}], 'interventions': [{'name': 'Mobile phone based physical activity with intervention', 'type': 'BEHAVIORAL', 'description': 'This group will receive a mobile phone software program and a pedometer. Over a 5-month period, participants in this group will be asked to participate in 6 in-person sessions, wear a pedometer, use a mobile phone physical activity and diet diary, and respond to daily physical activity and diet messages or video clips.', 'armGroupLabels': ['Physical Activity and Diet Intervention']}, {'name': 'Pedometer Only', 'type': 'BEHAVIORAL', 'description': 'This group will receive a pedometer. Over a 5-month period, participants in this group will be asked to wear a pedometer.', 'armGroupLabels': ['Pedometer only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Yoshimi Fukuoka, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}