Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT04743856
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2021-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Clinical Referral to Activity Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bjr26@pitt.edu', 'phone': '4126240188', 'title': 'Bonny Rockette-Wagner', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a small pilot study that was not powered to assess secondary outcomes. The ability to assess the primary outcome of number of participants meeting goal was affected by several factors including: higher than expected participants meeting goal at baseline (based on accelerometers) and higher than expected non-completion rates for the accelerometers.'}}, 'adverseEventsModule': {'timeFrame': 'From enrollment to end of follow-up, 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'PAT (Physical activity monitor)', 'description': 'Participants will receive a physical activity tracker and encouragement to increase physical activity.\n\nPAT: Participants will receive a physical activity tracker and encouragement to increase activity.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ActiveGOALSv2', 'description': 'Participants will receive the ActiveGOALS online program with an integrated activity tracker.\n\nActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAT (Physical activity monitor)', 'description': 'Participants will receive a physical activity tracker and encouragement to increase physical activity.\n\nPAT: Participants will receive a physical activity tracker and encouragement to increase activity.'}, {'id': 'OG001', 'title': 'ActiveGOALSv2', 'description': 'Participants will receive the ActiveGOALS online program with an integrated activity tracker.\n\nActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.'}], 'classes': [{'title': 'Baseline meeting goal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '12 months meeting goal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Apriori p-value for significance was \\<0.05. Models were not adjusted for additional covariates and multiple comparisons adjustment was not performed.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed models for binomial outcomes were run to determine if there were significant differences in meeting goal over time.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months versus baseline', 'description': 'Change between 0 and 12 months for y/n meeting the 150 minute/week moderate-vigorous activity goal based on minutes of activity from accelerometer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to participant drop out, incomplete monitor data at 12 months and loss to follow-up there were less people at the 12 month visit with valid monitor data', 'anticipatedPostingDate': '2025-12'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Step Counts at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAT (Physical activity monitor)', 'description': 'Participants will receive a physical activity tracker and encouragement to increase physical activity.\n\nPAT: Participants will receive a physical activity tracker and encouragement to increase activity.'}, {'id': 'OG001', 'title': 'ActiveGOALSv2', 'description': 'Participants will receive the ActiveGOALS online program with an integrated activity tracker.\n\nActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.'}], 'classes': [{'title': 'Baseline Adjusted Estimates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4574.21', 'spread': '421.86', 'groupId': 'OG000'}, {'value': '5028.41', 'spread': '413.78', 'groupId': 'OG001'}]}]}, {'title': '12 month Adjusted Estimates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4533.67', 'spread': '416.42', 'groupId': 'OG000'}, {'value': '5680.49', 'spread': '416.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0665', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-1106.28', 'pValueComment': 'Apriori significance level was p\\<0.05. No adjustment for multiple comparisons was made.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '592.76', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Models were not adjusted for additional variables.'}], 'paramType': 'MEAN', 'timeFrame': '12 months versus baseline', 'description': 'Objectively measured change in step counts between 0 and 12 months using ActiGraph accelerometer', 'unitOfMeasure': 'steps/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'there were less participants with valid data at the 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw', 'anticipatedPostingDate': '2026-01'}, {'type': 'SECONDARY', 'title': 'Sedentary Behavior Minutes Over All Timepoints for 12 Months', 'timeFrame': '1 week recording; measured at baseline, 6 and 12 months', 'description': 'Objectively measured sedentary behavior over all timepoints for 12 months using ActiGraph accelerometer', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months', 'timeFrame': '1 week recording; measured at baseline, 6 and 12 months', 'description': 'Objectively measured moderate-vigorous activity over all timepoints for 12 months using ActiGraph accelerometer', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Light Activity Minutes Over All Timepoints for 12 Months', 'timeFrame': '1 week recording; measured at baseline, 6 and 12 months', 'description': 'Objectively measured Light activity over all timepoints for 12 months using ActiGraph accelerometer', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Step Counts Over All Timepoints for 12 Months', 'timeFrame': '1 week recording; measured at baseline, 6 and 12 months', 'description': 'Objectively measured Step counts over all timepoints for 12 months using ActiGraph accelerometer', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Patient Experience', 'timeFrame': 'measured at 6 and 12 months', 'description': 'patient experience survey designed for this study with the help of patient partners to gather feedback from participants. Feedback will be used in the development of future interventions', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'Taken by trained clinic staff using a validated automated blood pressure cuff after participant is seated in an upright position for 5 minutes. Two measure will be taken and the average of the two measures will be used. If the measures are not within 5 mmHG, a third measure will be taken.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Body Weight Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'will be measured in clinic by trained staff using a validated scale. Participants will be asked to take shoes off and wear light clothes. Average of two measures will be used; if weight is more than .5 pounds different, a third will be taken.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Waist Circumference Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'will be measured above the iliac crest in clinic by trained staff. Two measures will be taken and averaged; if measures are more than 1 cm different a third measure will be taken.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Fasting Blood Glucose Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'HbA1c Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'LDL Cholesterol Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'HDL Cholesterol Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Perceived Health Score Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'EuroQAL Visual Analogue Scale (EQ-VAS)-Self-reported perception of health on a 0 (lowest possible) to 100 (highest possible) scale.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Insulin Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Triglycerides Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PAT (Physical activity monitor)', 'description': 'Participants will receive a physical activity tracker and encouragement to increase physical activity.\n\nPAT: Participants will receive a physical activity tracker and encouragement to increase activity.'}, {'id': 'FG001', 'title': 'ActiveGOALSv2', 'description': 'Participants will receive the ActiveGOALS online program with an integrated activity tracker.\n\nActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants enrolled between March 2022 and June 2023.', 'preAssignmentDetails': 'Participants were requirement to complete baseline measures for the primary outcome using accelerometer. Participants who withdrew, were found to not be meeting eligibility criteria, or did not completing the measure after consenting were not randomized and were administratively withdrawn.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PAT (Physical Activity Monitor)', 'description': 'Participants will receive a physical activity tracker and encouragement to increase physical activity.\n\nPAT: Participants will receive a physical activity tracker and encouragement to increase activity.'}, {'id': 'BG001', 'title': 'ActiveGOALSv2', 'description': 'Participants will receive the ActiveGOALS online program with an integrated activity tracker.\n\nActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.01', 'spread': '8.31', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '9.26', 'groupId': 'BG001'}, {'value': '57.36', 'spread': '8.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Meeting Activity Goal', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Based on 150 minutes/week from accelerometer', 'unitOfMeasure': 'Participants'}, {'title': 'Average Moderate-Vigorous Activity', 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '22.6', 'groupId': 'BG000'}, {'value': '34.83', 'spread': '23.48', 'groupId': 'BG001'}, {'value': '32.3', 'spread': '23.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average Light Activity', 'classes': [{'categories': [{'measurements': [{'value': '338.5', 'spread': '86.7', 'groupId': 'BG000'}, {'value': '354.1', 'spread': '94.1', 'groupId': 'BG001'}, {'value': '346.5', 'spread': '90.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average Sedentary', 'classes': [{'categories': [{'measurements': [{'value': '455.91', 'spread': '66.10', 'groupId': 'BG000'}, {'value': '463.27', 'spread': '112.57', 'groupId': 'BG001'}, {'value': '459.65', 'spread': '91.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average Step Counts', 'classes': [{'categories': [{'measurements': [{'value': '4564', 'spread': '2141', 'groupId': 'BG000'}, {'value': '5023', 'spread': '2222', 'groupId': 'BG001'}, {'value': '4797', 'spread': '2174', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'steps/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '122.6', 'spread': '17.1', 'groupId': 'BG000'}, {'value': '120.6', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '121.6', 'spread': '14.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHG', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '216.8', 'spread': '29.9', 'groupId': 'BG000'}, {'value': '207.4', 'spread': '33.1', 'groupId': 'BG001'}, {'value': '212.0', 'spread': '31.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '112.8', 'spread': '16.2', 'groupId': 'BG000'}, {'value': '108.2', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '110.5', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Blood Glucose', 'classes': [{'categories': [{'measurements': [{'value': '96.7', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '102.6', 'spread': '16.5', 'groupId': 'BG001'}, {'value': '99.7', 'spread': '15.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '5.42', 'spread': '0.46', 'groupId': 'BG000'}, {'value': '5.62', 'spread': '0.55', 'groupId': 'BG001'}, {'value': '5.52', 'spread': '0.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '116.4', 'spread': '43.5', 'groupId': 'BG000'}, {'value': '118.9', 'spread': '43.4', 'groupId': 'BG001'}, {'value': '117.6', 'spread': '43.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '53.0', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '53.9', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin', 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '16.0', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '16.0', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '128.9', 'spread': '54.1', 'groupId': 'BG000'}, {'value': '162.1', 'spread': '108.8', 'groupId': 'BG001'}, {'value': '145.5', 'spread': '86.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Pressure Diastolic', 'classes': [{'categories': [{'measurements': [{'value': '79', 'spread': '11', 'groupId': 'BG000'}, {'value': '79', 'spread': '9', 'groupId': 'BG001'}, {'value': '79', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHG', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-03', 'size': 1493027, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-04T09:19', 'hasProtocol': True}, {'date': '2025-11-03', 'size': 101395, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-04T09:18', 'hasProtocol': False}, {'date': '2022-02-22', 'size': 319088, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-04T09:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Referring doctors and outcome assessors will be blinded to participant assignment while the study is active. After data collection ends, referring physicians will be informed as to each of their patients assignment. Outcome assessors will remain blinded to participant assignment. Investigators will be blinded to assignment as much as possible. However, certain events ( such as an adverse event report) may cause the study PI to become unblinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized 1:1 to one of two intervention conditions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2021-01-10', 'resultsFirstSubmitDate': '2025-11-04', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-04', 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months', 'timeFrame': '12 months versus baseline', 'description': 'Change between 0 and 12 months for y/n meeting the 150 minute/week moderate-vigorous activity goal based on minutes of activity from accelerometer'}, {'measure': 'Change From Baseline in Step Counts at 12 Months', 'timeFrame': '12 months versus baseline', 'description': 'Objectively measured change in step counts between 0 and 12 months using ActiGraph accelerometer'}], 'secondaryOutcomes': [{'measure': 'Sedentary Behavior Minutes Over All Timepoints for 12 Months', 'timeFrame': '1 week recording; measured at baseline, 6 and 12 months', 'description': 'Objectively measured sedentary behavior over all timepoints for 12 months using ActiGraph accelerometer'}, {'measure': 'Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months', 'timeFrame': '1 week recording; measured at baseline, 6 and 12 months', 'description': 'Objectively measured moderate-vigorous activity over all timepoints for 12 months using ActiGraph accelerometer'}, {'measure': 'Light Activity Minutes Over All Timepoints for 12 Months', 'timeFrame': '1 week recording; measured at baseline, 6 and 12 months', 'description': 'Objectively measured Light activity over all timepoints for 12 months using ActiGraph accelerometer'}, {'measure': 'Step Counts Over All Timepoints for 12 Months', 'timeFrame': '1 week recording; measured at baseline, 6 and 12 months', 'description': 'Objectively measured Step counts over all timepoints for 12 months using ActiGraph accelerometer'}, {'measure': 'Patient Experience', 'timeFrame': 'measured at 6 and 12 months', 'description': 'patient experience survey designed for this study with the help of patient partners to gather feedback from participants. Feedback will be used in the development of future interventions'}, {'measure': 'Blood Pressure Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'Taken by trained clinic staff using a validated automated blood pressure cuff after participant is seated in an upright position for 5 minutes. Two measure will be taken and the average of the two measures will be used. If the measures are not within 5 mmHG, a third measure will be taken.'}, {'measure': 'Body Weight Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'will be measured in clinic by trained staff using a validated scale. Participants will be asked to take shoes off and wear light clothes. Average of two measures will be used; if weight is more than .5 pounds different, a third will be taken.'}, {'measure': 'Waist Circumference Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'will be measured above the iliac crest in clinic by trained staff. Two measures will be taken and averaged; if measures are more than 1 cm different a third measure will be taken.'}, {'measure': 'Fasting Blood Glucose Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.'}, {'measure': 'HbA1c Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.'}, {'measure': 'LDL Cholesterol Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.'}, {'measure': 'HDL Cholesterol Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.'}, {'measure': 'Perceived Health Score Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'EuroQAL Visual Analogue Scale (EQ-VAS)-Self-reported perception of health on a 0 (lowest possible) to 100 (highest possible) scale.'}, {'measure': 'Insulin Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.'}, {'measure': 'Triglycerides Over All Timepoints for 12 Months', 'timeFrame': 'measured at baseline, 6 and 12 months', 'description': 'A fasting blood draw will be taken after 12-16 hours fast.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical activity', 'Online lifestyle Intervention', 'Cardiovascular disease', 'Disease prevention'], 'conditions': ['Physical Inactivity', 'Cardiovascular Risk Factor', 'Obesity', 'Blood Pressure', 'PreDiabetes']}, 'descriptionModule': {'briefSummary': 'The main aim of this effort is to test a physical activity intervention, for adult clinical care patients at risk of developing cardiovascular disease. The intervention includes social-cognitive theory-based sessions, remote coaching, a body worn physical activity tracker (PAT), and is delivered online over one year. The investigators hypothesis that this intervention will be more successful at increasing physical activity (defined as objectively measured step counts and % of individuals meeting the moderate-vigorous physical activity goal) as an active control group who receives a body worn PAT and information on the CDC activity recommendations. The proposed intervention will be aligned with efforts by the US Centers for Disease Control to increase population physical activity levels and the American College of Sports Medicine (ACSM) to increase physical activity prescription in primary care.', 'detailedDescription': 'The main aim of this effort is to test a physical activity intervention, for adult clinical care patients at risk of developing cardiovascular disease. The intervention includes 13 weekly and 6 monthly social-cognitive theory-based sessions, remote coaching, a body worn physical activity tracker (PAT), and is delivered online over one year.\n\nA total of n=54 Clinical care patients aged 40-70 years of age with low physical activity (PA) levels (\\<150 minutes/week) at risk for cardiovascular disease will be recruited. Study outcomes will be measured at baseline, 6 months after intervention start and 12 months after intervention start.\n\nFor the primary outcomes, the investigators hypothesize that participants randomized to ActiveGOALSv2 + PAT will have significantly larger (a) increases in step counts/day and % meeting moderate-vigorous physical activity goal of 150 minutes/week (to 12 months) compared to the active PAT control group. Descriptive analyses and graphic displays will be used to identify outliers, missing data, and pattern of attrition. To ensure rigor, the primary analytic strategy will be a linear or generalized mixed-effect models approach in which treatment group, time, and time by group interaction are treated as fixed effects, and subject is treated as a random effect to account for individual subject variability (two sided hypothesis test; .05 level). Mixed models are applicable to longitudinal datasets that contain missing observations, (assuming data is missing at random). Regression modeling will be conducted to adjust for important covariates. The investigators will perform similar analyses to examine changes in secondary outcomes. Descriptive statistics on patient experience, beliefs/attitudes related to maintenance of physical activity changes, and program cost will also be reported.\n\nPower and sample size: For a 2 sided test with alpha level set at .05, and assuming 20% attrition at 12 months, the investigators plan to recruit 54 participants to identify clinically relevant mean difference between randomized groups at 12-months of 2000 steps/day (with a power of .80), and 35% meeting MVPA goal (with a power of .80), given reference mean (sd) values were calculated from baseline waist worn accelerometer data from the current K12 of: 5250 (2200) steps/ day and the investigators assume 5% meeting goal at baseline in the control group.\n\nDescriptive statistics will be used to describe the total eligible population, those referred, and those referred who participated in the study; in order to determine program reach. Exploratory Analysis of Important Pre-Existing Factors: Factor analysis will be used to identify importance of factors related to physical activity levels/ activity goal achievement over the 12 month follow-up (Mplus) from participant EHR data collected prior to intervention start. Factor structures of how individual factors contribute to activity outcomes will be explored at each time point. The best factor structure will be determined with Eigenvalues and fit indices (RMSEA, CFI, and TLI). Factor structures at the 2 time points will be compared at three levels to establish measurement invariance: 1) Configural equivalence, number of factors/ pattern of factor-indicator relationships are identical over time; 2) Metric equivalence, factor loadings are equal over time; and 3) Scalar equivalence, means and values are equivalent over time. Finally, the investigators will use descriptive statistics to report presence/absence of data on physical activity levels, cardiometabolic, and patient-centered outcomes in the EHR. The investigators will apply the same regression approaches utilized in Aim 1a to determine differences between randomized groups for EHR reported outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-70 years of age\n* Low physical activity (PA) levels (\\<150 minutes/week)\n* At least one of the following common cardiometabolic risk factors:\n\n * high blood pressure:\\> 129 mm hg SP or \\>89 mm hg DP or medication\n * high fasting glucose:\\>100 mg/dl or high HbA1c: ≥42 mmols/mol or medication\n * overweight/ obesity: BMI ≥25 kg/m2).\n* Have access to the internet\n* Able to read English at a 6th grade level\n* Have primary care provider (PCP) permission to increase physical activity without supervision.\n\nExclusion Criteria:\n\n* Have participated in a physical activity intervention program with behavior tracking and goal setting in the past year.\n* Told by a physician that they have diabetes (other than previous gestational diabetes) or have received a diagnosis of cardiovascular disease, regardless of when.\n* Pregnant or planning a pregnancy in \\<12 months\n* Non-ambulatory or planning a procedure that will lead to not being ambulatory in \\<12 months.\n* Women who become pregnant during the study will be required to get an updated referral form from their primary care provider (PCP) stating that they are able to increase their physical activity without supervision .'}, 'identificationModule': {'nctId': 'NCT04743856', 'briefTitle': 'The Clinical Referral to Activity Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Advancement of Clinical Referral to Physical Activity for Cardiometabolic Disease Prevention', 'orgStudyIdInfo': {'id': 'STUDY20030079'}, 'secondaryIdInfos': [{'id': '1K01HL151668-01', 'link': 'https://reporter.nih.gov/quickSearch/1K01HL151668-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PAT (Physical activity monitor)', 'description': 'Participants will receive a physical activity tracker and encouragement to increase physical activity.', 'interventionNames': ['Behavioral: PAT']}, {'type': 'EXPERIMENTAL', 'label': 'ActiveGOALSv2', 'description': 'Participants will receive the ActiveGOALS online program with an integrated activity tracker.', 'interventionNames': ['Behavioral: ActiveGOALSv2']}], 'interventions': [{'name': 'ActiveGOALSv2', 'type': 'BEHAVIORAL', 'description': '13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.', 'armGroupLabels': ['ActiveGOALSv2']}, {'name': 'PAT', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a physical activity tracker and encouragement to increase activity.', 'armGroupLabels': ['PAT (Physical activity monitor)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Bonny Rockette-Wagner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Bonny Rockette-Wagner', 'investigatorAffiliation': 'University of Pittsburgh'}}}}