Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT01571258
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2012-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Text4Diet: A Text Messaging Program for Weight Loss
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-04', 'studyFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': '6 months, 12 months', 'description': 'We will assess the difference in weight loss between the intervention and the control group at 6 months and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Pedometer Steps/Day', 'timeFrame': '6 months, 12 months', 'description': 'Change in average pedometer steps per day in the intervention group.'}, {'measure': 'Adherence', 'timeFrame': '6 months, 12 months', 'description': 'Level of adherence in responding to SMS. We also will investigate the correlation between adherence and weight loss.'}, {'measure': 'Treatment Satisfaction', 'timeFrame': '6 months and 12 months', 'description': 'We will assess satisfaction with the SMS intervention in the intervention group only.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SMS', 'Obesity', 'Text Messaging', 'Intervention', 'Mobile Phone'], 'conditions': ['Text Messaging (Intervention)', 'Control']}, 'descriptionModule': {'briefSummary': 'The purpose of the present RCT is to evaluate a 12-month SMS intervention with expanded content, intervention strategies and interactive database logic, novel online enrollment, and automatic baseline scoring of measures to support a 12 month weight loss SMS intervention. The investigators hypothesized that the intervention group would have greater weight loss at 6 and 12 months than the control group and increased adherence to SMS would be associated with greater weight loss at 6 and 12 months.', 'detailedDescription': 'Background: Text messaging shows promise as an intervention mode for many health conditions due to its accessibility and timeliness . Few studies have evaluated the effectiveness of text message-based interventions for weight loss. This study is a randomized controlled trial comparing an intervention of daily text messaging (Text4Diet) focused on weight-related behaviors to a control group.\n\nParticipant Involvement: One hundred seventy overweight or obese adults will have their height and weight measured and complete a battery of questionnaires at baseline, 6 and 12 months. Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire. The control group will receive only monthly newsletters but not text messages. Participants in both conditions will receive monetary compensation for participation, travel to the study site, and reimbursements for text messaging.\n\nParticipants: Inclusion criteria consists of: a) age: 21 to 65 years, b) overweight or obese status: BMI between 25.0 and 39.9, c) regular access to the Internet, d) own and regularly use a cell phone and know how to use SMS, d) ability to read and speak English, and e) ability to participate in moderate PA. Exclusion criteria consists of a) current pregnancy or the intention of becoming pregnant during the 12 month trial, b) moving out of the country during the 12 month trial, and c) current eating disorder.\n\nDates: Recruitment for the RCT began in September 2010. The RCT began in January 2011 and ended in December 2011. Data analysis will occur through June 2012.\n\nLocation: San Diego, CA\n\nRisks to Participants: This study involves low risk. Participation may involve some discomforts, such as embarrassment from sharing information about home environment, weight, and technology, diet, and exercise habits. There is a risk of loss of confidentiality of research information. All risks will be minimized according to the study protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 21 to 65 years\n* overweight or obese status: BMI between 25.0 and 39.9\n* regular access to the Internet\n* own and regularly use a cell phone and know how to use SMS\n* ability to read and speak English\n* ability to participate in moderate PA.\n\nExclusion Criteria:\n\n* current pregnancy or the intention of becoming pregnant during the 12 month trial\n* moving out of the country during the 12 month trial\n* current eating disorder'}, 'identificationModule': {'nctId': 'NCT01571258', 'acronym': 'Text4Diet', 'briefTitle': 'Text4Diet: A Text Messaging Program for Weight Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santech, Inc'}, 'officialTitle': 'Text4Diet: A Text Messaging Program for Weight Loss', 'orgStudyIdInfo': {'id': '4R44CA138011', 'link': 'https://reporter.nih.gov/quickSearch/4R44CA138011', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '4R44CA138011', 'link': 'https://reporter.nih.gov/quickSearch/4R44CA138011', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Text Messaging', 'description': 'Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire.', 'interventionNames': ['Behavioral: Text Messaging']}], 'interventions': [{'name': 'Text Messaging', 'type': 'BEHAVIORAL', 'description': 'Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire.', 'armGroupLabels': ['Text Messaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Santech, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Jennifer Shapiro, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Santech, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santech, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientific Director', 'investigatorFullName': 'Jennifer Shapiro, PhD', 'investigatorAffiliation': 'Santech, Inc'}}}}