Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-03 @ 6:04 AM
Study NCT ID:
NCT01724632
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2012-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LIVE SMART: Smartphone Intervention for Weight Control
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2012-11-06', 'studyFirstSubmitQcDate': '2012-11-07', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Engagement with Smartphone Treatment system', 'timeFrame': 'Mueasured continuously for the 18-month treatment.', 'description': 'Frequency and duration of use of intervention resources made available to the smartphone treatment arm.'}], 'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': 'Change from baseline to 18-months.'}], 'secondaryOutcomes': [{'measure': 'Weight-related Behaviors', 'timeFrame': 'Change from baseline to 18-months.', 'description': 'Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Weight Loss'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '38375882', 'type': 'DERIVED', 'citation': 'Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.'}, {'pmid': '31556659', 'type': 'DERIVED', 'citation': 'Goldstein SP, Goldstein CM, Bond DS, Raynor HA, Wing RR, Thomas JG. Associations between self-monitoring and weight change in behavioral weight loss interventions. Health Psychol. 2019 Dec;38(12):1128-1136. doi: 10.1037/hea0000800. Epub 2019 Sep 26.'}, {'pmid': '30779333', 'type': 'DERIVED', 'citation': 'Thomas JG, Bond DS, Raynor HA, Papandonatos GD, Wing RR. Comparison of Smartphone-Based Behavioral Obesity Treatment With Gold Standard Group Treatment and Control: A Randomized Trial. Obesity (Silver Spring). 2019 Apr;27(4):572-580. doi: 10.1002/oby.22410. Epub 2019 Feb 19.'}, {'pmid': '25475207', 'type': 'DERIVED', 'citation': "Bond DS, Thomas JG, O'Leary KC, Lipton RB, Peterlin BL, Roth J, Rathier L, Wing RR. Objectively measured physical activity in obese women with and without migraine. Cephalalgia. 2015 Sep;35(10):886-93. doi: 10.1177/0333102414562970. Epub 2014 Dec 4."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare three methods of delivering behavioral weight loss treatment.Participants are randomly assigned to one of three 18-month weight loss treatments (group, individual, or smartphone treatment). Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months. Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (kg/m2) of 25-45.\n* English language fluency\n* Ability to read at a 6th grade level\n* Availability to attend weekly treatment sessions in Providence, RI\n\nExclusion Criteria:\n\n* Any heart condition that limits ability to participate in physical activity\n* Chest Pain\n* Any cognitive of physical limitation that would preclude use of a smartphone\n* Serious mental illness\n* Historical or current eating disorder\n* Previous or planned bariatric surgery\n* Use of weight loss medication\n* Recent pregnancy or a plan to become pregnant in the next 6 months\n* Participation in a study at the Weight Control and Diabetes Research Center within the last two years\n* A weight loss of greater than 5% body weight in the last 6 months'}, 'identificationModule': {'nctId': 'NCT01724632', 'briefTitle': 'LIVE SMART: Smartphone Intervention for Weight Control', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'orgStudyIdInfo': {'id': '1R01DK095779', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK095779', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Treatment', 'description': 'Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants will be weighed individually at the start of each group meeting.', 'interventionNames': ['Behavioral: Lifestyle Counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Treatment', 'description': 'Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.', 'interventionNames': ['Behavioral: Lifestyle Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Smartphone Treatment', 'description': 'Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months.', 'interventionNames': ['Behavioral: Lifestyle Counseling']}], 'interventions': [{'name': 'Lifestyle Counseling', 'type': 'BEHAVIORAL', 'description': 'Participants receive instructions for making healthy changes to their diet and physical activity habits.', 'armGroupLabels': ['Group Treatment', 'Individual Treatment', 'Smartphone Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Weight Control and Diabetes Resarch Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor (Research)', 'investigatorFullName': 'John Graham Thomas', 'investigatorAffiliation': 'The Miriam Hospital'}}}}