Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-11 @ 1:16 PM
Study NCT ID:
NCT01155050
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2010-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Weight Loss in Chronic Disease Patient Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ronald.Horswell@pbrc.edu', 'phone': '225-763-2931', 'title': 'Ronald Horswell', 'organization': 'PenningtonBRC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Five months from baseline (randomization) through five-month follow-up', 'description': 'The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.', 'eventGroups': [{'id': 'EG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 1, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 3, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.", 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 6, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 3, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'mild or moderate unanticipated health events', 'notes': 'Includes (1) unanticipated outpatient clinic visits and (2) significant changes in reported health status not resulting in emergency department visits or hospitalization and deemed unrelated or unlikely to be related to the study interventions.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization and/or emergency department visit', 'notes': 'Hospitalization for any reason or an emergency department visit for any reason', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 31, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'unexpected outpatient clinic visit', 'notes': 'Unexpected/unplanned outpatient clinic visits for emergent conditions.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'OG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'OG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'OG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-.2', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '1.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.296', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis is that there are no differences in the outcome across groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'five-month follow-up compared to baseline', 'description': 'Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on those completing the five-month program and not lost to follow-up after five months.'}, {'type': 'PRIMARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'OG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'OG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'OG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.1', 'spread': '.7', 'groupId': 'OG000'}, {'value': '-.5', 'spread': '.8', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '.9', 'groupId': 'OG002'}, {'value': '-.6', 'spread': '1.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.787', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis is that there are no differences in the outcome across groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'five-month follow-up compared to baseline', 'description': 'Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done using those who completed the five-month programs and were not lost to follow-up at five months.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'OG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'OG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'OG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '-9.6', 'spread': '3.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.340', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis is that there are no differences in the outcome across groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.', 'description': 'Change is systolic blood pressure (mmHg) from baseline to five-month follow-up.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome results are for those who completed the study through five-months and were not lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'OG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'OG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'OG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '2.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.502', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis is that there are no differences in the outcome across groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.', 'description': 'Change in diastolic blood pressure (mmHg) from baseline to follow-up.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on those who completed the study through five months and were not lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'OG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'OG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'OG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.01', 'spread': '.21', 'groupId': 'OG000'}, {'value': '.19', 'spread': '.13', 'groupId': 'OG001'}, {'value': '.11', 'spread': '.19', 'groupId': 'OG002'}, {'value': '-.01', 'spread': '.08', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.860', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis is that the outcome does not differ across the four groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'five months', 'description': 'Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months.', 'unitOfMeasure': 'change in HbA1c percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on those who completed the study through five months and who had both baseline and follow-up lab results available from the electronic medical record.'}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'OG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'OG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'OG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '12', 'spread': '9.2', 'groupId': 'OG002'}, {'value': '2', 'spread': '10.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.634', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis is that the outcome does not differ across the four groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'five months', 'description': 'Change from baseline to five month follow-up in triglyceride level.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis was based on those subjects completing the study through five months and for whom triglyceride levels were available in the study sites' electronic medical records."}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'OG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'OG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'OG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.1', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '-.8', 'spread': '11.0', 'groupId': 'OG002'}, {'value': '-6.9', 'spread': '4.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.879', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis is that there is no difference in the outcome across the four treatment groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'five months', 'description': 'Change in total cholesterol level from baseline to five-month follow-up.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis is based on subjects completing the study through five months and who had total cholesterol lab values available in the study sites' electronic medical records."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'OG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'OG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'OG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '20.1', 'groupId': 'OG002'}, {'value': '10.9', 'spread': '9.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'five months', 'description': 'Change from baseline to five-month follow-up in fasting plasma glucose level.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis is based on those subjects who completed the study through five months and who had fast plasma glucose lab values available in the study sites' electronic medical record."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'FG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'FG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'FG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '22'}]}]}], 'recruitmentDetails': 'Subjects were recruited between January 1, 2010 and June 30, 2010. Recruitment was done at primary care clinics at three LSU Health Care Services Division locations in three Louisiana cities.', 'preAssignmentDetails': 'Potential subjects were screened for eligibility and then randomized within site to the four treatment arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.\n\nTele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.'}, {'id': 'BG001', 'title': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'id': 'BG002', 'title': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.\n\nTrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss."}, {'id': 'BG003', 'title': 'Home Monitoring + Telephone Coach', 'description': 'System to track stage of change in weight loss.\n\nTele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.04', 'spread': '9.74', 'groupId': 'BG000'}, {'value': '51.94', 'spread': '11.73', 'groupId': 'BG001'}, {'value': '50.62', 'spread': '9.87', 'groupId': 'BG002'}, {'value': '49.55', 'spread': '10.37', 'groupId': 'BG003'}, {'value': '50.80', 'spread': '10.41', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '186', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '111', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis of hypertension', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '193', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use diabetes medication', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use cholesterol medication', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use blood pressure medication', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '179', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use anti-depression medication', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low-density lipoprotein', 'classes': [{'categories': [{'measurements': [{'value': '118', 'spread': '32', 'groupId': 'BG000'}, {'value': '120', 'spread': '33', 'groupId': 'BG001'}, {'value': '117', 'spread': '41', 'groupId': 'BG002'}, {'value': '117', 'spread': '36', 'groupId': 'BG003'}, {'value': '118', 'spread': '35', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-density lipoprotein', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '12', 'groupId': 'BG000'}, {'value': '43', 'spread': '10', 'groupId': 'BG001'}, {'value': '48', 'spread': '18', 'groupId': 'BG002'}, {'value': '44', 'spread': '22', 'groupId': 'BG003'}, {'value': '44', 'spread': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '121', 'spread': '74', 'groupId': 'BG000'}, {'value': '111', 'spread': '57', 'groupId': 'BG001'}, {'value': '112', 'spread': '51', 'groupId': 'BG002'}, {'value': '153', 'spread': '145', 'groupId': 'BG003'}, {'value': '123', 'spread': '88', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '136', 'spread': '22', 'groupId': 'BG000'}, {'value': '140', 'spread': '16', 'groupId': 'BG001'}, {'value': '135', 'spread': '20', 'groupId': 'BG002'}, {'value': '142', 'spread': '21', 'groupId': 'BG003'}, {'value': '138', 'spread': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '80', 'spread': '16', 'groupId': 'BG000'}, {'value': '81', 'spread': '12', 'groupId': 'BG001'}, {'value': '78', 'spread': '11', 'groupId': 'BG002'}, {'value': '83', 'spread': '13', 'groupId': 'BG003'}, {'value': '80', 'spread': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '111', 'spread': '25', 'groupId': 'BG000'}, {'value': '106', 'spread': '26', 'groupId': 'BG001'}, {'value': '112', 'spread': '21', 'groupId': 'BG002'}, {'value': '113', 'spread': '25', 'groupId': 'BG003'}, {'value': '110', 'spread': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '9', 'groupId': 'BG000'}, {'value': '41', 'spread': '9', 'groupId': 'BG001'}, {'value': '42', 'spread': '7', 'groupId': 'BG002'}, {'value': '42', 'spread': '10', 'groupId': 'BG003'}, {'value': '41', 'spread': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '119', 'spread': '16', 'groupId': 'BG000'}, {'value': '118', 'spread': '16', 'groupId': 'BG001'}, {'value': '120', 'spread': '14', 'groupId': 'BG002'}, {'value': '115', 'spread': '21', 'groupId': 'BG003'}, {'value': '118', 'spread': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study randomized consenting subjects to four arms for evaluation of different weight loss strategies.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2010-06-29', 'resultsFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2010-06-30', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-03', 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': 'five-month follow-up compared to baseline', 'description': 'Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'five-month follow-up compared to baseline', 'description': 'Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters.'}], 'secondaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.', 'description': 'Change is systolic blood pressure (mmHg) from baseline to five-month follow-up.'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.', 'description': 'Change in diastolic blood pressure (mmHg) from baseline to follow-up.'}, {'measure': 'Change in HbA1c', 'timeFrame': 'five months', 'description': 'Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months.'}, {'measure': 'Change in Triglycerides', 'timeFrame': 'five months', 'description': 'Change from baseline to five month follow-up in triglyceride level.'}, {'measure': 'Change in Total Cholesterol', 'timeFrame': 'five months', 'description': 'Change in total cholesterol level from baseline to five-month follow-up.'}, {'measure': 'Change in Fasting Plasma Glucose', 'timeFrame': 'five months', 'description': 'Change from baseline to five-month follow-up in fasting plasma glucose level.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['overweight', 'obese', 'type II diabetes', 'hypertension'], 'conditions': ['Overweight', 'Obesity', 'Diabetes', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will assess the effect of in-home tele-health monitoring on health outcomes for LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or hypertension.', 'detailedDescription': 'This study will assess the effect of in-home tele-health monitoring on health outcomes for LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or hypertension. Primary emphasis will be on assessing the effect of tele-health home monitoring combined with motivational telephone coaching on weight loss and waist circumference as compared to self-directed, home monitoring alone, and telephone coaching alone. Secondary outcomes such as blood pressure, Hemoglobin A1c (HbA1c), fasting blood sugar, and cholesterol will be examined as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 yrs old\n* BMI ≥ 25 kg/m2 and waist circumference \\> 40 inches (men)/ 35 inches (women)\n* Weight ≤ 500lbs\n* At least one of the following:\n* Fasting blood sugar \\> 100 mg/dL at any point and/or taking medications for diabetes And/Or\n* Resting blood pressure \\> 130/90 mm Hg at any point and/or taking medications for hypertension\n* Not involved in regular physical activity or weight loss management programs\n* Capable of being physically active\n* Physically able to use in-home equipment (or presence of a household member who can assist the subject in equipment use)\n* Currently-working conventional telephone line at primary residence\n* Grounded electrical power supply at primary residence\n* Have been in LSU HCSD system for 6 months and anticipate remaining in the LSU HCSD patient population for the next 6 months\n\nExclusion Criteria:\n\n* A history of drug abuse in the last year, or excess alcohol consumption (40g/day)6\n* Currently dieting or engaging in any activity with the goal of losing weight\n* Significant weight loss or weight gain in the past year (\\> 50 lbs) or current use of weight loss medications\n* History of gastrointestinal bypass or other bariatric surgery in the last 3 years\n* Diagnosis of congestive heart failure\n* Under treatment for end-stage renal disease or end-stage liver disease\n* History of major organ transplant\n* History of cancers requiring treatment in the past 5 years with anything but excellent prognosis\n* Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders\n* Pregnant or plan on becoming pregnant in the next 12 months.\n* Lack support from health care provider or family members.\n* Current member of household participating in study\n* Factors that may limit adherence to intervention or affect conduct of the trial.\n* Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.\n* Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.'}, 'identificationModule': {'nctId': 'NCT01155050', 'briefTitle': 'Weight Loss in Chronic Disease Patient Population', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Louisiana State University Health Care Services Division (LSUHCSD) Tele-Health Projects: Weight Loss in Chronic Disease Patient Population', 'orgStudyIdInfo': {'id': 'PBRC 29032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tele-health Home Monitoring', 'description': 'Participants will use the tele-health monitoring equipment to measure daily weight.', 'interventionNames': ['Device: Tele-health Home Monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Self-Directed Group', 'description': 'Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TrestleTree Telephone Coaching', 'description': "Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss.", 'interventionNames': ['Behavioral: TrestleTree Telephone Coaching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home monitoring + telephone coach', 'description': 'System to track stage of change in weight loss.', 'interventionNames': ['Device: Tele-health Home Monitoring Plus Trestle Telephone Coaching']}], 'interventions': [{'name': 'Tele-health Home Monitoring', 'type': 'DEVICE', 'otherNames': ['Home Monitoring'], 'description': 'Daily tele-health monitoring data will be collected from randomized participants.', 'armGroupLabels': ['Tele-health Home Monitoring']}, {'name': 'TrestleTree Telephone Coaching', 'type': 'BEHAVIORAL', 'otherNames': ['Telephone Coaching'], 'description': 'Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.', 'armGroupLabels': ['TrestleTree Telephone Coaching']}, {'name': 'Tele-health Home Monitoring Plus Trestle Telephone Coaching', 'type': 'DEVICE', 'otherNames': ['Home Monitoring and telephone coaching'], 'description': 'Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.', 'armGroupLabels': ['Home monitoring + telephone coach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70806', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Earl K. Long Medical Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70363', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Leonard J. Chabert Medical Center', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '70607', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'WO Moss Regional Medical Center', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}], 'overallOfficials': [{'name': 'Timothy S. Church, MD, MPH, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pennington Biomedical Research Center'}, {'name': 'Donna H. Ryan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pennington Biomedical Research Center'}, {'name': 'Valerie H. Myers, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pennington Biomedical Research Center'}, {'name': 'Ronald W. Horswell, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pennington Biomedical Research Center'}, {'name': 'Monisha Chadha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louisiana State University Health Care Services Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}