Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT01357551
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maintenance After Initiation of Nutrition TrAINing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'corrine.voils@va.gov', 'phone': '9192860411', 'title': 'Dr. Corrine Voils', 'phoneExt': '5196', 'organization': 'Durham VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'May not generalize to other populations; relatively short length of follow-up; use of self-reported secondary outcome measures'}}, 'adverseEventsModule': {'timeFrame': '56-week study period', 'eventGroups': [{'id': 'EG000', 'title': 'Maintenance Intervention', 'description': 'Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.\n\nMaintenance intervention: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.', 'otherNumAtRisk': 110, 'otherNumAffected': 0, 'seriousNumAtRisk': 110, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Participants receive usual care for 56 weeks', 'otherNumAtRisk': 112, 'otherNumAffected': 0, 'seriousNumAtRisk': 112, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Emergency room visit due to high blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'emergency room visit due to knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency room visit due to anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Intervention', 'description': 'Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.\n\nInterventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants are randomized to receive usual care for 56 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '99.2', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '105.7', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '.07', 'ciUpperLimit': '3.13', 'pValueComment': 'A priori threshold was p\\<.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.78', 'groupDescription': 'The sample size estimate was based on the primary hypothesis that patients randomized to receive the maintenance intervention would have less mean weight regain at week 56 than those randomized to usual care. The week 0 standard deviation was estimated as 24.6kg, the correlation between week 0 and week 56 as 0.95, and the week 56 dropout rate as 10%. To detect a difference of 3.5 kg with 90% power and a type I error rate of 5%, 230 total (115 in each group) randomized patients were needed.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Parameters included common intercept, initial weight loss stratum, dummy-coded time, and indicators for the maintenance X each follow-up time point', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '56 weeks post-randomization', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Daily Caloric Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Intervention', 'description': 'Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.\n\nInterventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants receive usual care for 56 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1207.5', 'spread': '548.3', 'groupId': 'OG000'}, {'value': '1339.1', 'spread': '750.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-125.49', 'ciLowerLimit': '-280.71', 'ciUpperLimit': '29.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '78.64', 'groupDescription': 'The hypothesis was that patients randomized to receive the maintenance intervention would have less caloric intake at week 56 than those randomized to usual care.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Common intercept, initial weight loss stratum, indicators for week 26 \\& 56, group X time interaction', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '56 weeks', 'description': 'Based on self-report using Block Brief Food Frequency Questionnaire', 'unitOfMeasure': 'kcal per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Metabolic Minutes of Walking Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Intervention', 'description': 'Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.\n\nInterventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants receive usual care for 56 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '680.72', 'spread': '721.23', 'groupId': 'OG000'}, {'value': '665.43', 'spread': '822.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.26', 'groupDescription': 'The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of walking per week at week 56 than those randomized to usual care.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Common intercept, initial weight loss stratum, indicators for week 26 \\& 56, group X time interaction; negative binomial distribution with log link', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '56 weeks', 'description': 'self-reported based on short form of International Physical Activity Questionnaire', 'unitOfMeasure': 'metabolic minutes per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Metabolic Minutes of Moderate Physical Activity Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Intervention', 'description': 'Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.\n\nInterventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants receive usual care for 56 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '783.40', 'spread': '1175.57', 'groupId': 'OG000'}, {'value': '810.25', 'spread': '1215.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.83', 'groupIds': ['OG000', 'OG001'], 'paramType': 'incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.57', 'ciUpperLimit': '2.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.35', 'groupDescription': 'The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of moderate physical activity per week at week 56 than those randomized to usual care.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Common intercept, initial weight loss stratum, indicators for week 26 \\& 56, group X time interaction; negative binomial distribution with log link', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '56 weeks', 'description': 'self-reported based on short form of International Physical Activity Questionnaire', 'unitOfMeasure': 'metabolic minutes per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maintenance Intervention', 'description': 'Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.\n\nInterventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Participants receive usual care for 56 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': '573 people were consented. Of those, 69 did not return to provide a weight at study entry. Of the 504 who provided a weight at study entry, 200 dropped out, 82 lost \\< 4 kg, and 222 lost at least 4 kg and thus were eligible for randomization in the maintenance phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Maintenance Intervention', 'description': 'Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.\n\nInterventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Participants are randomized to receive usual care for 56 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '61.8', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '38', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight loss during initiation phase', 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '3.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '102.1', 'spread': '19.8', 'groupId': 'BG000'}, {'value': '105.0', 'spread': '21.0', 'groupId': 'BG001'}, {'value': '103.6', 'spread': '20.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '34.6', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '34.0', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per meter squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Education', 'classes': [{'title': 'high school graduate', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}, {'title': 'not high school graduate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current tobacco user', 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Employment status', 'classes': [{'title': 'working full time or part-time', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'retired', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'other/disabled', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2011-05-13', 'resultsFirstSubmitDate': '2016-09-13', 'studyFirstSubmitQcDate': '2011-05-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-13', 'studyFirstPostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': '56 weeks post-randomization'}], 'secondaryOutcomes': [{'measure': 'Estimated Daily Caloric Intake', 'timeFrame': '56 weeks', 'description': 'Based on self-report using Block Brief Food Frequency Questionnaire'}, {'measure': 'Estimated Metabolic Minutes of Walking Per Week', 'timeFrame': '56 weeks', 'description': 'self-reported based on short form of International Physical Activity Questionnaire'}, {'measure': 'Estimated Metabolic Minutes of Moderate Physical Activity Per Week', 'timeFrame': '56 weeks', 'description': 'self-reported based on short form of International Physical Activity Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'intervention studies', 'patient adherence'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24347145', 'type': 'RESULT', 'citation': 'Voils CI, Gierisch JM, Yancy WS Jr, Sandelowski M, Smith R, Bolton J, Strauss JL. Differentiating Behavior Initiation and Maintenance: Theoretical Framework and Proof of Concept. Health Educ Behav. 2014 Jun;41(3):325-36. doi: 10.1177/1090198113515242. Epub 2013 Dec 16.'}, {'pmid': '25117805', 'type': 'RESULT', 'citation': 'Voils CI, Gierisch JM, Olsen MK, Maciejewski ML, Grubber J, McVay MA, Strauss JL, Bolton J, Gaillard L, Strawbridge E, Yancy WS Jr. Study design and protocol for a theory-based behavioral intervention focusing on maintenance of weight loss: the Maintenance After Initiation of Nutrition TrAINing (MAINTAIN) study. Contemp Clin Trials. 2014 Sep;39(1):95-105. doi: 10.1016/j.cct.2014.08.002. Epub 2014 Aug 10.'}, {'pmid': '37546286', 'type': 'DERIVED', 'citation': 'Gavin KL, Almeida EJ, Voils CI, Crane MM, Shaw R, Yancy WS Jr, Pendergast J, Olsen MK. Comparison of weight captured via electronic health record and cellular scales to the gold-standard clinical method. Obes Sci Pract. 2023 Jan 12;9(4):337-345. doi: 10.1002/osp4.656. eCollection 2023 Aug.'}, {'pmid': '28853051', 'type': 'DERIVED', 'citation': 'Funk LM, Grubber JM, McVay MA, Olsen MK, Yancy WS, Voils CI. Patient predictors of weight loss following a behavioral weight management intervention among US Veterans with severe obesity. Eat Weight Disord. 2018 Oct;23(5):587-595. doi: 10.1007/s40519-017-0425-6. Epub 2017 Aug 29.'}, {'pmid': '28241185', 'type': 'DERIVED', 'citation': 'Voils CI, Olsen MK, Gierisch JM, McVay MA, Grubber JM, Gaillard L, Bolton J, Maciejewski ML, Strawbridge E, Yancy WS Jr. Maintenance of Weight Loss After Initiation of Nutrition Training: A Randomized Trial. Ann Intern Med. 2017 Apr 4;166(7):463-471. doi: 10.7326/M16-2160. Epub 2017 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'Obesity is the second leading cause of preventable deaths in the United States and is associated with a wide range of diseases. In people who are obese, weight loss improves blood pressure, dyslipidemia, glycemia, and arthritis symptoms; reduces medication use for several disease processes; increases physical functioning; and enhances health-related quality of life. The current study evaluated a theoretically informed maintenance intervention. If effective, this intervention could reduce the need for future clinic visits to treat obesity and its many associated illnesses.', 'detailedDescription': 'Obesity is the second leading cause of preventable deaths in the United States and is associated with a wide range of diseases. In people who are obese, weight loss improves blood pressure, dyslipidemia, glycemia, and arthritis symptoms; reduces medication use for several disease processes; increases physical functioning; and enhances health-related quality of life. Despite these benefits, most patients who achieve weight loss regain much of this weight within a year, and few effective behavioral weight maintenance interventions have been identified. Thus, there is a dire need for effective interventions that can promote weight loss maintenance. Theoretical and empirical studies indicate that behavior maintenance is a distinct state that involves different psychological processes and behavioral skills than initial behavior change. The few trials that have tested weight loss maintenance interventions have not taken this distinction into account, which may partially explain their modest findings. The current study evaluated the efficacy of a theoretically informed maintenance intervention compared to usual care. If efficacious, this intervention could reduce the need for future clinic visits to treat obesity and its many associated illnesses and could serve as a model for redesigning the MOVE! program. This 3.5-year study involved a two-arm, randomized, controlled trial. During the run-in phase, Veterans with BMI 30 kg/m2 participated in a 4-month, intensive, group-based weight loss program. Participants who lost at least 4 kg by the end of 4 months (n=222) were randomized to receive (a) usual care (n=112) for 56 weeks or (b) a theoretically-informed maintenance intervention (n=110) for 42 weeks months, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention involved in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually tapered over time. Outcomes were assessed at randomization and at weeks 14, 26, 42, and 56 post-randomization. The hypotheses are that the maintenance intervention will result in at least 3.5 kg greater weight loss and greater improvements in caloric intake and physical activity over the study period, and that it will be cost-effective, compared to usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>= 30 kg/m2\n* Desire to lose weight\n* Agrees to attend regular visits per study protocol\n* Has a provider at the Durham Veterans Affairs Medical Center\n\nExclusion Criteria:\n\n* Age \\>= 75 years old,\n* Most recent serum creatinine \\>2.0 mg/dL in men, \\>1.7 mg/dL in women),\n* Liver disease (cirrhosis, jaundice, or other stigmata of advanced liver disease),\n* Type 1 diabetes,\n* Hemoglobin A1c \\>= 12% in past 6 months\n* unstable angina or coronary ischemia workup in past 3 months\n* Female: pregnancy, breastfeeding, or lack of birth control if premenopausal\n* Transplant recipient\n* Pacemaker or defibrillator (bioelectric impedance assessment might interfere with these)\n* Average systolic blood pressure in the past year \\>= 160 mmHg AND most recent BP \\>=160 mmHg\n* Dementia, severe psychiatric illness (e.g., major depression), alcohol problem, or illicit substance abuse\n* Weight loss of at least 10 lb in previous 3 months\n* Enrollment in a weight loss program\n* Unable to stand for study measurements\n* history of weight loss surgery\n* cancer not in remission\n* current use of appetite suppressants or weight loss medication\n* lack of reliable transportation or telephone'}, 'identificationModule': {'nctId': 'NCT01357551', 'acronym': 'MAINTAIN', 'briefTitle': 'Maintenance After Initiation of Nutrition TrAINing', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Maintenance After Initiation of Nutrition TrAINing (MAINTAIN)', 'orgStudyIdInfo': {'id': 'IIR 11-040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maintenance intervention', 'description': 'Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.', 'interventionNames': ['Behavioral: Maintenance intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Participants receive usual care for 56 weeks'}], 'interventions': [{'name': 'Maintenance intervention', 'type': 'BEHAVIORAL', 'description': 'Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.', 'armGroupLabels': ['Maintenance intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Corrine I Voils, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA Medical Center, Durham, NC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}