Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-18 @ 12:05 AM
Study NCT ID:
NCT01578512
Status:
UNKNOWN
Last Update Posted:
2012-04-17
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPARK a Healthy and Fit Lifestyle
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-16', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': '2 months (post-treatment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the best format for delivering a brief behavioral weight loss intervention to young adults 18-25 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-25 years old\n* body mass index 25-45\n* willing to be randomly assigned to any of the 3 arms\n* available during the time frame of the study\n* willing to complete assessment visits at 0, 2, 4 and 6 months\n\nExclusion Criteria:\n\n* Age or BMI outside of eligible range\n* Medical condition that would interfere with weight loss or make unsupervised physical activity unsafe\n* Pregnant or nursing within 6 months\n* recent weight loss \\>10% of body weight\n* History of eating disorder\n* Substance abuse or dependence'}, 'identificationModule': {'nctId': 'NCT01578512', 'acronym': 'SPARK', 'briefTitle': 'SPARK a Healthy and Fit Lifestyle', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'SPARK a Healthy and Fit Lifestyle', 'orgStudyIdInfo': {'id': 'DK083440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Face-to-Face', 'description': '8 sessions of weekly group behavioral weight loss treatment', 'interventionNames': ['Behavioral: Face-to-Face']}, {'type': 'EXPERIMENTAL', 'label': 'Web-based', 'description': 'Participants receive one group face-to-face session followed by 7 web-based lessons, reporting of key behaviors, and feedback on progress.', 'interventionNames': ['Behavioral: Web-based']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single Session', 'description': 'Single session behavioral weight loss', 'interventionNames': ['Behavioral: Single session']}], 'interventions': [{'name': 'Face-to-Face', 'type': 'BEHAVIORAL', 'description': 'Face-to-Face behavioral weight loss', 'armGroupLabels': ['Face-to-Face']}, {'name': 'Web-based', 'type': 'BEHAVIORAL', 'description': 'Web-based behavioral weight loss', 'armGroupLabels': ['Web-based']}, {'name': 'Single session', 'type': 'BEHAVIORAL', 'description': 'The core of behavioral weight loss, including calorie and activity prescriptions, are delivered in a single group treatment session.', 'armGroupLabels': ['Single Session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica LaRose, PhD', 'role': 'CONTACT', 'phone': '401-793-8283'}, {'name': 'Jessica G LaRose, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rena R Wing, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Weight Control and Diabetes Research Center, the Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Jessica LaRose, PhD', 'role': 'CONTACT', 'email': 'jessica_gokee_larose@brown.edu', 'phone': '401-793-8283'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}