Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT01043718
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2010-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2010-01-05', 'studyFirstSubmitQcDate': '2010-01-05', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight (kg)', 'timeFrame': '6 months, 12 months, 18 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of body weight lost', 'timeFrame': '6 months, 12 months, 18 months'}, {'measure': 'Change in blood pressure (mm Hg)', 'timeFrame': '6 months, 12 months, 18 months'}, {'measure': 'Change in health-related quality of life as determined by the RAND-36 PCS or MCS', 'timeFrame': '6 months, 12 months, 18 months'}, {'measure': 'Change in physical activity (steps per day)', 'timeFrame': '6 months, 12 months, 18 months'}, {'measure': 'Change in dietary pattern', 'timeFrame': '6 months, 12 months, 18 months'}, {'measure': 'Satisfaction with program', 'timeFrame': '6 months, 12 months, 18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Internet'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '12453955', 'type': 'BACKGROUND', 'citation': 'Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.'}]}, 'descriptionModule': {'briefSummary': 'Hershey Medical Center and the University of Pittsburgh are doing a research study to help meet the needs of the adult population at risk for diabetes and heart disease. This study will provide a web-based program that aims to help participants to develop healthier eating habits, lose weight and become more physically active. The Internet-based materials will teach participants about healthy eating and physical activity and will ask them to incorporate the information they learn into their daily lives.\n\nThe purpose of this study is to evaluate the effectiveness of online lifestyle change programs to promote weight loss, healthy eating and physical activity patterns, in the interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and cardiovascular disease (CVD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Please note: Only individuals who receive primary care at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA, are eligible for this study.\n\nInclusion Criteria:\n\n* Age between 18 and 80 years old\n* Obese based on World Health Organization criteria (BMI\\>30kg/m2)\n* Receiving primary care from and referred by a provider at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA\n* Able to understand and sign an informed consent document\n* Able to communicate with the investigator and understand the requirements of this study\n\nExclusion Criteria\n\n* Primary care provider determines that the individual is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)\n* Primary care provider determines that the individual has inadequate cognitive function to participate in either active intervention curricula\n* Women who are pregnant, who are planning to become pregnant in the next two years, or who become pregnant during the study\n* Women who are breastfeeding\n* Prisoners\n* Children\n* Individuals who are planning to have bariatric surgery or who have had bariatric surgery in the past two years\n* Individuals with uncontrolled hypertension (systolic blood pressure (SBP) \\>165, diastolic blood pressure (DBP) \\>100)\n* Individuals with an edematous state that interferes with body weight assessment (e.g., severe congestive heart failure, end- stage renal disease, or ascites),\n* Individuals already using weight loss therapy\n* Individuals with an inability to learn adequately from English language audio-taped materials\n* Individuals with a lack of high-speed Internet access (Internet access will be based on participant perception; for example, participants could use computers belonging to friends, relatives, or libraries if they feel that they can access them regularly)\n* Individuals without access to a scale\n* Individuals unable to attend an Orientation session at Hershey Medical Center in Hershey, PA'}, 'identificationModule': {'nctId': 'NCT01043718', 'briefTitle': 'Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'HMC32877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'More-Intensive', 'interventionNames': ['Behavioral: More-Intensive']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Less-Intensive', 'interventionNames': ['Behavioral: Less-Intensive']}], 'interventions': [{'name': 'More-Intensive', 'type': 'BEHAVIORAL', 'description': 'The online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program. The program will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs. The program curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives.', 'armGroupLabels': ['More-Intensive']}, {'name': 'Less-Intensive', 'type': 'BEHAVIORAL', 'description': 'The participants will be provided with the information to access the online Diabetes Prevention Program (DPP) intervention materials. Following the original DPP trial, all DPP materials were placed online for the public to access. This group will receive a lifestyle counseling session and tools to facilitate their intervention.', 'armGroupLabels': ['Less-Intensive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Kathleen McTigue, MD MS MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, {'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kathleen McTigue', 'investigatorAffiliation': 'University of Pittsburgh'}}}}