Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-01 @ 4:18 PM
Study NCT ID:
NCT01776632
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Promoting Physical Activity in Churchgoing Latinas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'earredon@sdsu.edu', 'phone': '(619) 594-3481', 'title': 'Elva Arredondo', 'organization': 'San Diego State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The current study was implemented with Latina women attending Catholic churches, the findings may not generalize to men, members of other ethnic groups, or Latino groups of other denominations.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 24 months (2 years)', 'eventGroups': [{'id': 'EG000', 'title': 'Physical Activity', 'description': "Latinas exposed to multi-level Faith in Action intervention promoting physical activity.\n\nPhysical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors.", 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 1, 'seriousNumAtRisk': 217, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cancer Screening', 'description': 'Latinas exposed to Faith in Action intervention on cancer screening and prevention.\n\nCancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 0, 'seriousNumAtRisk': 219, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'broken ankle', 'notes': 'Study participant fell and broke ankle during walking group', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Activity', 'description': "Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.\n\nPhysical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."}, {'id': 'OG001', 'title': 'Cancer Screening', 'description': 'Latinas exposed to Faith in Action intervention on cancer screening and prevention.\n\nCancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.'}], 'classes': [{'categories': [{'measurements': [{'value': '144.4', 'spread': '117.9', 'groupId': 'OG000'}, {'value': '129.9', 'spread': '125.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.15', 'statisticalMethod': 'generalized linear mixed effects', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported', 'description': 'Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer', 'unitOfMeasure': 'minutes/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 369 participants (183 physical activity condition, 186 cancer screening condition) had valid accelerometer data at 12-month follow-up measures. Those without valid data (unmet wear time, lost device, etc) were not included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Self-report Leisure-time MVPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Activity', 'description': "Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.\n\nPhysical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."}, {'id': 'OG001', 'title': 'Cancer Screening', 'description': 'Latinas exposed to Faith in Action intervention on cancer screening and prevention.\n\nCancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.'}], 'classes': [{'categories': [{'measurements': [{'value': '138.2', 'spread': '178.0', 'groupId': 'OG000'}, {'value': '91.7', 'spread': '134.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.39', 'statisticalMethod': 'generalized linear mixed effects', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported', 'description': 'Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity', 'unitOfMeasure': 'minutes/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 375 participants (187 physical activity condition, 188 cancer screening condition) had valid self-report leisure-time data at 12-month follow-up measures. Those without valid data (incomplete data, etc) were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Activity', 'description': "Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.\n\nPhysical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."}, {'id': 'OG001', 'title': 'Cancer Screening', 'description': 'Latinas exposed to Faith in Action intervention on cancer screening and prevention.\n\nCancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.18', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '30.60', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.43', 'statisticalMethod': 'mixed effects models', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported', 'description': 'Change from baseline in body mass index (BMI)', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 361 participants (178 physical activity condition, 183 cancer screening condition) had valid BMI data at 12-month follow-up measures. Those without valid data (incomplete anthrometric measures, etc) were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Activity', 'description': "Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.\n\nPhysical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."}, {'id': 'OG001', 'title': 'Cancer Screening', 'description': 'Latinas exposed to Faith in Action intervention on cancer screening and prevention.\n\nCancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.20', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '96.56', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.27', 'statisticalMethod': 'mixed effects models', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported', 'description': 'Change from baseline in waist circumference', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 361 participants (178 physical activity condition, 183 cancer screening condition) had valid waist circumference data at 12-month follow-up measures. Those without valid data (incomplete anthropometrics, etc) were not included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Physical Activity', 'description': "Latinas exposed to multi-level Faith in Action intervention promoting physical activity.\n\nPhysical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."}, {'id': 'FG001', 'title': 'Cancer Screening', 'description': 'Latinas exposed to Faith in Action intervention on cancer screening and prevention.\n\nCancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Physical Activity', 'description': "Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.\n\nPhysical activity: Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors."}, {'id': 'BG001', 'title': 'Cancer Screening', 'description': 'Latinas exposed to Faith in Action intervention on cancer screening and prevention.\n\nCancer screening: Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '44.4', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '44.4', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Accelerometer-based moderate-to-vigorous physical activity (MVPA)', 'classes': [{'categories': [{'measurements': [{'value': '98.8', 'spread': '61.5', 'groupId': 'BG000'}, {'value': '107.6', 'spread': '65.8', 'groupId': 'BG001'}, {'value': '103.2', 'spread': '63.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes/week', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Self-report leisure-time MVPA', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '121.1', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '104.1', 'groupId': 'BG001'}, {'value': '67.6', 'spread': '112.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes/week', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '29.9', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '30.3', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'spread': '15.0', 'groupId': 'BG000'}, {'value': '94.1', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '94.9', 'spread': '14.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 436}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2015-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2012-10-29', 'resultsFirstSubmitDate': '2019-02-04', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-20', 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)', 'timeFrame': 'assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported', 'description': 'Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer'}, {'measure': 'Self-report Leisure-time MVPA', 'timeFrame': 'assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported', 'description': 'Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': 'assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported', 'description': 'Change from baseline in body mass index (BMI)'}, {'measure': 'Waist Circumference', 'timeFrame': 'assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported', 'description': 'Change from baseline in waist circumference'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Disease']}, 'referencesModule': {'references': [{'pmid': '26358535', 'type': 'BACKGROUND', 'citation': 'Arredondo EM, Haughton J, Ayala GX, Slymen DJ, Sallis JF, Burke K, Holub C, Chanson D, Perez LG, Valdivia R, Ryan S, Elder J. Fe en Accion/Faith in Action: Design and implementation of a church-based randomized trial to promote physical activity and cancer screening among churchgoing Latinas. Contemp Clin Trials. 2015 Nov;45(Pt B):404-415. doi: 10.1016/j.cct.2015.09.008. Epub 2015 Sep 8.'}, {'pmid': '26280587', 'type': 'BACKGROUND', 'citation': 'Haughton J, Ayala GX, Burke KH, Elder JP, Montanez J, Arredondo EM. Community Health Workers Promoting Physical Activity: Targeting Multiple Levels of the Social Ecological Model. J Ambul Care Manage. 2015 Oct-Dec;38(4):309-20. doi: 10.1097/JAC.0000000000000108.'}, {'pmid': '27536927', 'type': 'BACKGROUND', 'citation': 'Beard M, Chuang E, Haughton J, Arredondo EM. Determinants of Implementation Effectiveness in a Physical Activity Program for Church-Going Latinas. Fam Community Health. 2016 Oct-Dec;39(4):225-33. doi: 10.1097/FCH.0000000000000122.'}, {'pmid': '27412175', 'type': 'BACKGROUND', 'citation': "Perez LG, Slymen DJ, Sallis JF, Ayala GX, Elder JP, Arredondo EM. Interactions between individual and perceived environmental factors on Latinas' physical activity. J Public Health (Oxf). 2017 Jun 1;39(2):e10-e18. doi: 10.1093/pubmed/fdw061."}, {'pmid': '27679665', 'type': 'BACKGROUND', 'citation': 'Perez LG, Chavez A, Marquez DX, Soto SC, Haughton J, Arredondo EM. Associations of Acculturation With Self-Report and Objective Physical Activity and Sedentary Behaviors Among Latinas. Health Educ Behav. 2017 Jun;44(3):431-438. doi: 10.1177/1090198116669802. Epub 2016 Sep 27.'}, {'pmid': '27818913', 'type': 'BACKGROUND', 'citation': "Perez LG, Carlson J, Slymen DJ, Patrick K, Kerr J, Godbole S, Elder JP, Ayala GX, Arredondo EM. Does the social environment moderate associations of the built environment with Latinas' objectively-measured neighborhood outdoor physical activity? Prev Med Rep. 2016 Oct 19;4:551-557. doi: 10.1016/j.pmedr.2016.10.006. eCollection 2016 Dec."}, {'pmid': '29214856', 'type': 'BACKGROUND', 'citation': 'Tristao Parra M, Porfirio GJM, Arredondo EM, Atallah AN. Physical Activity Interventions in Faith-Based Organizations: A Systematic Review. Am J Health Promot. 2018 Mar;32(3):677-690. doi: 10.1177/0890117116688107. Epub 2017 Jan 13.'}, {'pmid': '28380627', 'type': 'BACKGROUND', 'citation': 'Elder JP, Haughton J, Perez LG, Martinez ME, De la Torre CL, Slymen DJ, Arredondo EM. Promoting cancer screening among churchgoing Latinas: Fe en Accion/faith in action. Health Educ Res. 2017 Apr 1;32(2):163-173. doi: 10.1093/her/cyx033.'}, {'pmid': '28359166', 'type': 'BACKGROUND', 'citation': 'Soto SH, Arredondo EM, Haughton J, Shakya H. Leisure-Time Physical Activity and Characteristics of Social Network Support for Exercise Among Latinas. Am J Health Promot. 2018 Feb;32(2):432-439. doi: 10.1177/0890117117699927. Epub 2017 Mar 31.'}, {'pmid': '28752364', 'type': 'BACKGROUND', 'citation': "Perez LG, Elder JP, Haughton J, Martinez ME, Arredondo EM. Socio-demographic Moderators of Associations Between Psychological Factors and Latinas' Breast Cancer Screening Behaviors. J Immigr Minor Health. 2018 Aug;20(4):823-830. doi: 10.1007/s10903-017-0633-1."}, {'pmid': '29166779', 'type': 'BACKGROUND', 'citation': 'Perez LG, Kerr J, Sallis JF, Slymen D, McKenzie TL, Elder JP, Arredondo EM. Perceived Neighborhood Environmental Factors That Maximize the Effectiveness of a Multilevel Intervention Promoting Physical Activity Among Latinas. Am J Health Promot. 2018 Feb;32(2):334-343. doi: 10.1177/0890117117742999. Epub 2017 Nov 22.'}, {'pmid': '28520484', 'type': 'RESULT', 'citation': 'Arredondo EM, Elder JP, Haughton J, Slymen DJ, Sallis JF, Perez LG, Serrano N, Parra MT, Valdivia R, Ayala GX. Fe en Accion: Promoting Physical Activity Among Churchgoing Latinas. Am J Public Health. 2017 Jul;107(7):1109-1115. doi: 10.2105/AJPH.2017.303785. Epub 2017 May 18.'}, {'pmid': '35907867', 'type': 'DERIVED', 'citation': 'Arredondo EM, Haughton J, Ayala GX, Slymen D, Sallis JF, Perez LG, Serrano N, Ryan S, Valdivia R, Lopez NV, Elder JP. Two-year outcomes of Faith in Action/Fe en Accion: a randomized controlled trial of physical activity promotion in Latinas. Int J Behav Nutr Phys Act. 2022 Jul 30;19(1):97. doi: 10.1186/s12966-022-01329-6.'}]}, 'descriptionModule': {'briefSummary': 'The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas likely contributes to the high rates of cancer and other chronic diseases in this population. The goals of the current study, based largely upon the core principles of the Social Ecological Model, are to design, implement, and evaluate an innovative multi-level intervention promoting physical activity among churchgoing Latinas.\n\nThe evidenced-based intervention targets three "tiers" of environmental influences (i.e., church, immediate neighborhood surrounding the church, and community) on activity, as well as MVPA-related personal factors (i.e.., interpersonal, cultural, and perceived environmental variables). The physical activity intervention will be compared with an attention-control condition providing health education on cancer screening and prevention.\n\nSixteen churches will be randomly assigned to either the physical activity intervention or the attention-control condition. The primary aim of the study is to determine whether a multi-level intervention will increase MVPA among Latina churchgoers in the intervention condition relative to the attention-control condition.', 'detailedDescription': "This two-group randomized controlled trial combines innovative and traditional methods for promoting moderate-to-vigorous physical activity (MVPA) and cancer screening (breast, cervical, colorectal, and skin) among Latinas, and is tested simultaneously in a two-group design. Both interventions lasted two years. The study's primary outcome was min/week of accelerometer-assessed MVPA at baseline (M1) and 12 months (M2) and 24 months (M3) following the start of the intervention.We selected cancer screening as a comparison condition given the relevance of this topic to our target community (i.e., low cervical and colorectal cancer screening rates and follow-up). It was hypothesized that over time, participants in the physical activity condition would engage in significantly higher levels of MVPA, compared to participants in the cancer screening condition. We also expected greater changes in individual-, interpersonal-, and environmental-level correlates of physical activity among participants in the physical activity condition compared to those in the cancer screening condition. Conversely, we expected that participants in the cancer screening condition would engage in higher screening rates compared to those in the physical activity intervention.We anticipated greater changes in individual, interpersonal, and environmental correlates of cancer screening in this condition compared to the physical activity condition."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-65 years of age\n* Latino\n* Must be a member of a participating church for at least six months\n* Live within 10-15 minutes driving distance from the church\n* Able to travel to the church during the week\n* Able to attend activities at the church during the week\n* Attend church activities (worship or otherwise) at least 4 times a month\n* Plan on living in same residence for the next 24 months\n* Engage in less than 150 minutes of moderate-to-vigorous physical activity per week\n\nExclusion Criteria:\n\n* Attendance at other churches participating in the study\n* Must not have any conditions limiting ability to be physically active\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01776632', 'briefTitle': 'Promoting Physical Activity in Churchgoing Latinas', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)', 'orgStudyIdInfo': {'id': 'R01CA138894', 'link': 'https://reporter.nih.gov/quickSearch/R01CA138894', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01CA138894-05S1', 'link': 'https://reporter.nih.gov/quickSearch/R01CA138894-05S1', 'type': 'NIH'}, {'id': 'R01CA138894-05S2', 'link': 'https://reporter.nih.gov/quickSearch/R01CA138894-05S2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity', 'description': 'Latinas exposed to multi-level Faith in Action intervention promoting physical activity.', 'interventionNames': ['Behavioral: Physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cancer screening', 'description': 'Latinas exposed to Faith in Action intervention on cancer screening and prevention.', 'interventionNames': ['Behavioral: Cancer screening']}], 'interventions': [{'name': 'Physical activity', 'type': 'BEHAVIORAL', 'otherNames': ['Faith in Action', 'Fe en Acción'], 'description': "Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors.", 'armGroupLabels': ['Physical activity']}, {'name': 'Cancer screening', 'type': 'BEHAVIORAL', 'description': 'Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals.', 'armGroupLabels': ['Cancer screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego State University Research Foundation', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Elva M Arredondo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elva Arredondo', 'investigatorAffiliation': 'San Diego State University'}}}}