Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-30 @ 8:14 AM
Study NCT ID:
NCT02632461
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2015-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intervention Examining Tracking With Mobile Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight as assessed by digital scale', 'timeFrame': '6 months', 'description': 'Change in body weight from baseline to 6 months as assessed by digital scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diet', 'Weight Loss', 'Tracking', 'Calories'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '31155473', 'type': 'DERIVED', 'citation': 'Turner-McGrievy GM, Dunn CG, Wilcox S, Boutte AK, Hutto B, Hoover A, Muth E. Defining Adherence to Mobile Dietary Self-Monitoring and Assessing Tracking Over Time: Tracking at Least Two Eating Occasions per Day Is Best Marker of Adherence within Two Different Mobile Health Randomized Weight Loss Interventions. J Acad Nutr Diet. 2019 Sep;119(9):1516-1524. doi: 10.1016/j.jand.2019.03.012. Epub 2019 May 30.'}, {'pmid': '28600833', 'type': 'DERIVED', 'citation': 'Turner-McGrievy GM, Wilcox S, Boutte A, Hutto BE, Singletary C, Muth ER, Hoover AW. The Dietary Intervention to Enhance Tracking with Mobile Devices (DIET Mobile) Study: A 6-Month Randomized Weight Loss Trial. Obesity (Silver Spring). 2017 Aug;25(8):1336-1342. doi: 10.1002/oby.21889. Epub 2017 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test the effectiveness of two different weight loss interventions. Both of these interventions will provide weight loss information through twice weekly audio podcasts. In addition to the podcasts, participants will be asked to track their diet using either a wearable device on their wrist or through an app on their smartphone.', 'detailedDescription': 'This study will last approximately 6 months. Participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting. Additional assessments will be conducted at 3 months and 6 months. Weekly questionnaires will be administered. Everyone in the study will be asked to listen to 2 podcasts per week. Each of the podcasts will take about 15 - 20 minutes to listen to and so participants should expect to spend 30 - 40 minutes each week listening to podcasts. Participants will also be randomized to either track diet with an app on their smartphone or using a device they wear on their wrist. Each week, participants will be sent an email as a reminder on how to use their diet tracking device. They will also be encouraged to monitor their exercise and body weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be between 18-65 years old\n* Own and use a smartphone and/or a tablet with a data plan\n* BMI must be between 25-49.9 kg/m2\n* Must be willing to reduce caloric intake and increase physical activity\n* Not currently participating in a weight loss study in a weight loss study that involved podcasts\n\nExclusion Criteria:\n\n* Over the age of 65 years old\n* Currently participating in a weight loss program\n* Has lost more than 10 pounds in the past 6 months\n* Diagnosed with stroke or heart attack\n* Diagnosed with diabetes that is controlled using medication'}, 'identificationModule': {'nctId': 'NCT02632461', 'acronym': 'DIETMobile', 'briefTitle': 'Dietary Intervention Examining Tracking With Mobile Devices', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'The Dietary Intervention Examining Tracking With Mobile Devices Study', 'orgStudyIdInfo': {'id': 'Pro00049756'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Podcast (+Bite Counter)', 'description': 'Participants in this group will receive podcasts twice weekly in conjunction with using a wearable wrist device called a Bite Counter. The Bite Counter tracks the number of bites/calories per bite. (Podcasts plus Bite Counter)', 'interventionNames': ['Behavioral: Podcasts', 'Behavioral: Bite Counter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Podcast (+Mobile App)', 'description': 'Participants in this group will receive podcasts twice weekly in conjunction with using a mobile application to track their diet. (Podcasts plus Mobile Diet Application)', 'interventionNames': ['Behavioral: Podcasts', 'Behavioral: Mobile Diet Application']}], 'interventions': [{'name': 'Podcasts', 'type': 'BEHAVIORAL', 'description': 'Participants will receive twice weekly podcasts that will cover topics related to weight loss.', 'armGroupLabels': ['Podcast (+Bite Counter)', 'Podcast (+Mobile App)']}, {'name': 'Mobile Diet Application', 'type': 'BEHAVIORAL', 'description': 'Participants will use a mobile application on their smartphone to track their diet.', 'armGroupLabels': ['Podcast (+Mobile App)']}, {'name': 'Bite Counter', 'type': 'BEHAVIORAL', 'description': 'Participants will use a wrist-worn Bite Counter to track the number of bites in their diet per day.', 'armGroupLabels': ['Podcast (+Bite Counter)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Brie Turner-McGrievy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brie Turner-McGrievy', 'investigatorAffiliation': 'University of South Carolina'}}}}