Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT04751656
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2021-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment (STEADY)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'megan.mcvay@ufl.edu', 'phone': '352-294-1638', 'title': 'Megan McVay', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'adverse events could be spontaneously reported to study staff. No formal assessment of adverse events was done.', 'eventGroups': [{'id': 'EG000', 'title': 'Steady Intervention Enrollees', 'description': 'Participants who enrolled in the Steady Intervention', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intervention Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Steady Intervention Enrollees', 'description': 'Participants who enrolled in the Steady Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months.', 'description': '(NOTE: this is a pilot study and there is not a true primary outcome. There are several descriptive outcomes that will inform our decision to proceed to a traditional, fully powered clincial trial).\n\nIntervention satisfaction reported here is response to item "overall, I am satisfied with this program." with response options 1-5, 1-strongly disagree, 3-neither agree nor disagree, and 5-strongly agree.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed 12 month assessment'}, {'type': 'SECONDARY', 'title': 'Retention in Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Steady Intervention Enrollees', 'description': 'Participants who enrolled in the Steady Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Percent of participants completing 12 month survey. (There is no measurement used for this. It is based on the portion of patients who complete the 12 month survey.)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Engagement in Self Weighing, First Quarter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Steady Intervention Enrollees', 'description': 'Participants who enrolled in the Steady Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'months 0-3', 'description': 'days/week in which weight was registered', 'unitOfMeasure': 'days/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Engagement in Self Weighing, Final Quarter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Steady Intervention Enrollees', 'description': 'Participants who enrolled in the Steady Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'months 9-12', 'description': 'mean days per week in which weight was registered', 'unitOfMeasure': 'days/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Patients Who Enroll', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Steady Intervention', 'description': 'Participants asked to engage in Steady Intervention for 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at recruitment', 'description': 'Percent of those who are eligible who are interested in and enroll in the Steady Intervention out of those who complete the screening measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'those who were offered steady'}, {'type': 'SECONDARY', 'title': 'Representatives of Those Who Enroll', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Steady Intervention Enrollees', 'description': 'Participants who enrolled in the Steady Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At recruitment', 'description': 'Percent of those participants who enroll who are male.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Evidence-based Resources Offered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Steady Intervention Enrollees', 'description': 'Participants who enrolled in the Steady Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Percent of patients who initiate use of comprehensive weight loss program', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Steady Intervention Enrollees', 'description': 'Participants who enrolled in the Steady Intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Steady Intervention Enrollees', 'description': 'Participants who enrolled in the Steady Intervention'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.7', 'spread': '13.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-04', 'size': 472862, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-02T15:39', 'hasProtocol': True}, {'date': '2020-10-20', 'size': 585165, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-02T15:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2021-02-09', 'resultsFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-03', 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Satisfaction', 'timeFrame': '12 months.', 'description': '(NOTE: this is a pilot study and there is not a true primary outcome. There are several descriptive outcomes that will inform our decision to proceed to a traditional, fully powered clincial trial).\n\nIntervention satisfaction reported here is response to item "overall, I am satisfied with this program." with response options 1-5, 1-strongly disagree, 3-neither agree nor disagree, and 5-strongly agree.'}], 'secondaryOutcomes': [{'measure': 'Retention in Study', 'timeFrame': '12 months', 'description': 'Percent of participants completing 12 month survey. (There is no measurement used for this. It is based on the portion of patients who complete the 12 month survey.)'}, {'measure': 'Engagement in Self Weighing, First Quarter', 'timeFrame': 'months 0-3', 'description': 'days/week in which weight was registered'}, {'measure': 'Engagement in Self Weighing, Final Quarter', 'timeFrame': 'months 9-12', 'description': 'mean days per week in which weight was registered'}, {'measure': 'Percent of Patients Who Enroll', 'timeFrame': 'at recruitment', 'description': 'Percent of those who are eligible who are interested in and enroll in the Steady Intervention out of those who complete the screening measure.'}, {'measure': 'Representatives of Those Who Enroll', 'timeFrame': 'At recruitment', 'description': 'Percent of those participants who enroll who are male.'}, {'measure': 'Use of Evidence-based Resources Offered', 'timeFrame': '12 months', 'description': 'Percent of patients who initiate use of comprehensive weight loss program'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot trial is to pilot test an intervention to help prevent weight gain or produce weight loss among adults with obesity. Participants are asked to self-weigh on a smart scale for one year. Feasibility and acceptability outcomes are examined.', 'detailedDescription': 'To prevent weight gain while overcoming these common barriers to engaging in weight management interventions, we propose an intervention that prescribes self-weighing but does not prescribe changes in diet or physical activity behaviors or require attendance at didactic-focused meetings. The potential of self-weighing to promote weight management is supported both by self-regulatory theory and empirical research. Promoting self-weighing may activate participants\' self-regulatory skills, leading to spontaneous decisions to reduce calorie intake or increase physical activity, thus preventing further weight gain. The proposed intervention will also provide individuals with text message-based feedback to promote continued self-weighing and to motivate engagement with evidence-based resources for weight management at a time when they may be more open to using these resources-e.g., after experiencing a small weight gain. The current proposal will investigate the feasibility and acceptability of this low burden self-weighing intervention in order to prepare for a fully-powered, pragmatic randomized controlled trial. We will enroll 40 patients with either obesity or overweight with a weight-related comorbidity and who have declined to participate in a comprehensive behavioral weight management program. Participants will be asked to weigh themselves daily via a "smart" scale that transmits weight data directly to the study team via the cellular network. Every-other week, participants will be sent text messages providing brief feedback encouraging continued self-weighing. Moreover, if a small weight gain is observed, participants will be sent text messages aiming to engage them in commercial or community-based evidence-based weight management resources. In a single-arm design, all enrolled participants will receive the intervention for 12 months and will complete assessments at 3 and 12 months to assess feasibility and acceptability of the intervention and trial design, while weight will be obtained from participants\' Electronic Health Records (EHR). We will evaluate our success in meeting pre-specified metrics for trial feasibility and intervention acceptability outcomes, including intervention enrollment, intervention satisfaction, and obtainment of weight data abstracted from participants\' EHRs. We will also evaluate the success of the intervention in promoting regular self-weighing and use of evidence-based weight management resources.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70\n* Body weight recorded in EHR in the prior month from a primary care setting.\n* Last BMI in EHR either ≥30 kg/m2 or between 25.0-29.9 kg/m2 with documented weight-related comorbidity (hypertension, type II diabetes, pre-diabetes, dyslipidemia, sleep apnea).\n* Weight ≤ 375 lbs.\n* Self-report sending and receiving at least one text message per month for past 6 months.\n* Not currently enrolled in comprehensive behavioral weight loss treatment.\n* Respond "no" to question asking if they would like to enroll in a comprehensive weight loss program in the next month\n* Has not engaged in self-weighing ≥ 5 times per week on average over prior month.\n* Not pregnant, breastfeeding, or planning to become pregnant in next 6 months.\n* Not currently undergoing radiation or chemotherapy for cancer.\n* No history of eating disorders.\n* Interested in enrolling in low-burden self-weighing intervention.\n* Able to read and understand English without help\n\nExclusion criteria:\n\n* History of Congestive Heart Failure or heart attack in past 6 months.\n* Planning to move out of the region in the following 12 months\n* Answer incorrectly on an attention check/ validation survey item'}, 'identificationModule': {'nctId': 'NCT04751656', 'acronym': 'STEADY', 'briefTitle': 'Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment (STEADY)', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment', 'orgStudyIdInfo': {'id': 'IRB202001935-N-R'}, 'secondaryIdInfos': [{'id': '5R03HL154272-02', 'link': 'https://reporter.nih.gov/quickSearch/5R03HL154272-02', 'type': 'NIH'}, {'id': 'AWD08696', 'type': 'OTHER', 'domain': 'UFIRST Awards'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Steady Intervention', 'description': 'Participants asked to engage in Steady Intervention for 12 months', 'interventionNames': ['Behavioral: Steady Intervention']}], 'interventions': [{'name': 'Steady Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to weigh themselves daily via a "smart" scale that transmits weight data directly to the study team via the cellular network for 12 months. Every-other week, participants will be sent text messages providing brief feedback encouraging continued self-weighing. Moreover, if a small weight gain is observed, participants will be sent text messages aiming to engage them in commercial or community-based evidence-based weight management resources.', 'armGroupLabels': ['Steady Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Megan McVay, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Per guidelines for sharing in the NHLBI repository, the data set will be submitted to the NHLBI program officer as soon as it is prepared, and no later than 3 years after the end of clinical activities.', 'ipdSharing': 'YES', 'description': 'The dataset will be prepared according to requirements for NHLBI data repository datasets and will be stored in the NHLBI data repository.', 'accessCriteria': 'Consistent with NHLBI repository guidelines.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}