Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-04-07 @ 3:47 PM
Study NCT ID:
NCT02053259
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2014-01-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Walking Intervention Through Text Messaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D050177', 'term': 'Overweight'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098408', 'term': 'Reinforcement Machine Learning'}], 'ancestors': [{'id': 'D000069550', 'term': 'Machine Learning'}, {'id': 'D001185', 'term': 'Artificial Intelligence'}, {'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marc.adams@asu.edu', 'phone': '602-827-2470', 'title': 'Dr. Marc Adams', 'organization': 'Arizona State University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Not all of the secondary outcome data have been analyzed and some results are pending review by a journal.'}}, 'adverseEventsModule': {'timeFrame': 'Continuously over the course of the 4-month intervention period.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'Adaptive Goals, Reinforcement\n\nAdaptive Goals\n\nReinforcement', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2', 'description': 'Adaptive Goals, No Reinforcement\n\nAdaptive Goals', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 3', 'description': 'Static Goals, Reinforcement\n\nReinforcement\n\nStatic Goals', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Arm 4', 'description': 'Static Goals, No reinforcement\n\nStatic Goals', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Adaptive Goals', 'description': 'Adaptive goals'}, {'id': 'OG001', 'title': 'Static Goals', 'description': 'Static goals'}, {'id': 'OG002', 'title': 'Immediate Reinforcement', 'description': 'Immediate reinforcement'}, {'id': 'OG003', 'title': 'Delayed Non-contingent Reinforcement', 'description': 'Delayed non-contingent reinforcement'}], 'classes': [{'categories': [{'measurements': [{'value': '9695', 'spread': '3948', 'groupId': 'OG000'}, {'value': '9836', 'spread': '3930', 'groupId': 'OG001'}, {'value': '10562', 'spread': '4032', 'groupId': 'OG002'}, {'value': '8969', 'spread': '3802', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily for 4 months', 'description': 'Given this study used a 2 condition (adaptive vs. static goals) x 2 condition (immediate vs. delayed financial reinforcement) randomized factorial design we report main effects for each condition. Sample sizes for main effects will be 96 participants for each comparison (Adaptive vs. Static goals or Immediate vs. Delayed Reinforcement) as the other condition. Consistent with proper analyses of factorial designs, main effects for the goal setting conditions pool participants across reinforcement conditions, and main effects for reinforcement conditions pool participants across goal setting conditions.', 'unitOfMeasure': 'steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2x2 factorial design main effects reported. Main effects for goal setting (n=49 for adaptive vs. n=47 for static) and reinforcement conditions (n=49 for immediate reinforcement vs. n=47 for delayed, non-contingent reinforcement).'}, {'type': 'SECONDARY', 'title': 'Change in Fitness (VO2max) Between Study Arms.', 'timeFrame': 'Baseline and 4 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2023-01'}, {'type': 'SECONDARY', 'title': 'Changes in Body Mass Index and Body Composition Measured by Dual-energy X-Ray Absorptiometry (DEXA) Between Study Arms.', 'timeFrame': 'Baseline and 4 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2023-01'}, {'type': 'SECONDARY', 'title': 'Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms.', 'timeFrame': 'Baseline and 4 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2023-01'}, {'type': 'SECONDARY', 'title': 'Changes to Cardiovascular-disease (CVD) Risk and Inflammatory Markers (e.g. Glucose, Insulin, Lipids, Adhesion Molecules and Hemostatic Factors) Between Groups.', 'timeFrame': 'Baseline and 4 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2023-01'}, {'type': 'SECONDARY', 'title': 'Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ).', 'timeFrame': 'Baseline and 4 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2023-01'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adaptive Physical Activity Goals With Immediate Reinforcement', 'description': 'Adaptive Physical Activity Goals with Immediate Reinforcement'}, {'id': 'FG001', 'title': 'Adaptive Physical Activity Goals With Delayed Reinforcement', 'description': 'Adaptive Physical Activity Goals with Delayed Reinforcement'}, {'id': 'FG002', 'title': 'Static Physical Activity Goals With Immediate Reinforcement', 'description': 'Static Physical Activity Goals with Immediate Reinforcement'}, {'id': 'FG003', 'title': 'Static Physical Activity Goals With Delayed Reinforcement', 'description': 'Static Physical Activity Goals with Delayed Reinforcement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1', 'description': 'Adaptive with Immediate Rewards'}, {'id': 'BG001', 'title': 'Arm 2', 'description': 'Adaptive with Delayed Rewards'}, {'id': 'BG002', 'title': 'Arm 3', 'description': 'Static with Immediate Rewards'}, {'id': 'BG003', 'title': 'Arm 4', 'description': 'Static with Delayed Non-Contingent Rewards'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': '10.16', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '10.70', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '8.22', 'groupId': 'BG002'}, {'value': '40.3', 'spread': '7.91', 'groupId': 'BG003'}, {'value': '41.0', 'spread': '9.46', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2014-01-31', 'resultsFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2014-01-31', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-11', 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms.', 'timeFrame': 'Daily for 4 months', 'description': 'Given this study used a 2 condition (adaptive vs. static goals) x 2 condition (immediate vs. delayed financial reinforcement) randomized factorial design we report main effects for each condition. Sample sizes for main effects will be 96 participants for each comparison (Adaptive vs. Static goals or Immediate vs. Delayed Reinforcement) as the other condition. Consistent with proper analyses of factorial designs, main effects for the goal setting conditions pool participants across reinforcement conditions, and main effects for reinforcement conditions pool participants across goal setting conditions.'}], 'secondaryOutcomes': [{'measure': 'Change in Fitness (VO2max) Between Study Arms.', 'timeFrame': 'Baseline and 4 months'}, {'measure': 'Changes in Body Mass Index and Body Composition Measured by Dual-energy X-Ray Absorptiometry (DEXA) Between Study Arms.', 'timeFrame': 'Baseline and 4 months'}, {'measure': 'Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms.', 'timeFrame': 'Baseline and 4 months'}, {'measure': 'Changes to Cardiovascular-disease (CVD) Risk and Inflammatory Markers (e.g. Glucose, Insulin, Lipids, Adhesion Molecules and Hemostatic Factors) Between Groups.', 'timeFrame': 'Baseline and 4 months'}, {'measure': 'Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ).', 'timeFrame': 'Baseline and 4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Physical Activity', 'Behavior', 'Overweight', 'Motor Activity']}, 'referencesModule': {'references': [{'pmid': '26362511', 'type': 'BACKGROUND', 'citation': 'Hurley JC, Hollingshead KE, Todd M, Jarrett CL, Tucker WJ, Angadi SS, Adams MA. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults. JMIR Res Protoc. 2015 Sep 11;4(3):e108. doi: 10.2196/resprot.4856.'}, {'pmid': '28356097', 'type': 'RESULT', 'citation': "Adams MA, Hurley JC, Todd M, Bhuiyan N, Jarrett CL, Tucker WJ, Hollingshead KE, Angadi SS. Adaptive goal setting and financial incentives: a 2 x 2 factorial randomized controlled trial to increase adults' physical activity. BMC Public Health. 2017 Mar 29;17(1):286. doi: 10.1186/s12889-017-4197-8."}, {'pmid': '30973315', 'type': 'RESULT', 'citation': 'Phillips CB, Hurley JC, Angadi SS, Todd M, Berardi V, Hovell MF, Adams MA. Delay Discount Rate Moderates a Physical Activity Intervention Testing Immediate Rewards. Behav Med. 2020 Apr-Jun;46(2):142-152. doi: 10.1080/08964289.2019.1570071. Epub 2019 Apr 11.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to develop and evaluate adaptive goal setting and feedback interventions (Adaptive Interventions) to promote physical activity behaviors and compare it to static physical activity interventions (Static Interventions) using two levels of goal setting (Adaptive Goals vs. Static Goals) and two levels of reinforcement procedures (Praise/Rewards and No Praise/Rewards) in a 2 x 2 factorial randomized controlled trial. All four groups will receive the intervention via a semi-automated text message system developed by the investigators study team.\n\nThe primary aim of this study will be to:\n\n1. Evaluate whether the adaptive interventions result in greater change in physical activity (pedometer-measured steps/day) compared to the static Intervention groups. HYPOTHESES: Participants in the adaptive interventions will increase their steps/day more than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups.\n\n The secondary aims of this study will be to:\n2. Evaluate the effectiveness of the adaptive and static goal interventions in improving anthropometric, cardiovascular fitness, and cardiometabolic risk factors. HYPOTHESES: Participants in the adaptive interventions will show greater improvements in fitness, lean and fat body mass, and serum biomarkers than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups.\n3. to assess participants' satisfaction with the overall program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women and men of all races/ethnicities living in Maricopa County, Arizona.\n\nExclusion Criteria:\n\n* be between 18 and 60 years old\n* currently not exceeding physical activity recommendations determined by the International Physical Activity Questionnaire (IPAQ short form).\n* not have a medical condition based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) that requires supervised physical activity\n* not taking medication(s) that would prohibit a moderate intensity physical activity program\n* have a body mass index between 25 and 55 kg/m2\n* not be currently pregnant or planning to become pregnant in the next 4 months\n* not be planning to leave Maricopa County for 10 days or more in the next 4 months\n* not planning to move from Maricopa County in the next 4 months\n* not currently in another physical activity, diet, or weight loss program (e.g. weight watchers)\n* have access to Microsoft Windows (XP, Vista, 7, 8) or Mac (10.5+) operating systems on computer with a USB port on a daily basis\n* have daily access to email and the internet\n* have a mobile phone with text messaging capabilities and be willing to send and receive up to 3-5 text messages per day.'}, 'identificationModule': {'nctId': 'NCT02053259', 'acronym': 'WalkIT', 'briefTitle': 'A Walking Intervention Through Text Messaging', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Walking Intervention Through Texting Study: A Factorial Trial', 'orgStudyIdInfo': {'id': 'ASU-SNHP01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adaptive Goals with Immediate Reinforcement', 'description': 'Adaptive Physical Activity Goals, Immediate Financial Reinforcement', 'interventionNames': ['Behavioral: Adaptive Goals', 'Behavioral: Reinforcement']}, {'type': 'EXPERIMENTAL', 'label': 'Adaptive Goals with Delayed Reinforcement', 'description': 'Adaptive Physical Activity Goals, Delayed Financial Reinforcement', 'interventionNames': ['Behavioral: Adaptive Goals']}, {'type': 'EXPERIMENTAL', 'label': 'Static Goals with Immediate Reinforcement', 'description': 'Static Physical Activity Goals, Immediate Financial Reinforcement', 'interventionNames': ['Behavioral: Reinforcement', 'Behavioral: Static Goals']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Static Goals with Delayed Reinforcement', 'description': 'Static Physical Activity Goals, Delayed Financial Reinforcement', 'interventionNames': ['Behavioral: Static Goals']}], 'interventions': [{'name': 'Adaptive Goals', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Adaptive Goals with Delayed Reinforcement', 'Adaptive Goals with Immediate Reinforcement']}, {'name': 'Reinforcement', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Adaptive Goals with Immediate Reinforcement', 'Static Goals with Immediate Reinforcement']}, {'name': 'Static Goals', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Static Goals with Delayed Reinforcement', 'Static Goals with Immediate Reinforcement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona State Univertsity, School of Nutrition and Health Promotion', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, College of Health Solutions', 'investigatorFullName': 'Marc Adams, PhD, MPH', 'investigatorAffiliation': 'Arizona State University'}}}}