Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT02835495
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2016-07-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mvitolinn@wakehealth.edu', 'phone': '(336) 716-2886', 'title': 'Mara Z. Vitolins, DrPH, MPH, RDN', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'As this was a pilot feasibility study, only a small number of participants were included and analyzed.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Adverse events were reported at the 6-month follow-up visit using a standardized questionnaire.', 'eventGroups': [{'id': 'EG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recruitment of Study Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Proportion of Eligible Participants of Total Screened', 'description': 'This reports the total number of participants who were screened and determined to be eligible for the study.'}, {'id': 'OG001', 'title': 'Proportion of Eligible Participants Who Were Randomized', 'description': 'This reports the total number of participants who were randomized of those eligible for participation.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'To characterize the ability to recruit Veterans to participate in this pilot study, the proportion of Veterans screened who are eligible to participate and the proportion of eligible participants who agree to participate will be calculated. The rate of referrals to the program by providers in the local community-based outpatient clinic will also be monitored.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Retention of Study Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'To characterize the ability to retain Veterans in this pilot study, the percentage of participants who complete the study (attendance at the 6-month assessment visit) as a measure of overall study retention will be calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adherence to the Lifestyle Weight Loss Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The proportion of intervention sessions attended will be calculated.', 'unitOfMeasure': 'sessions attended', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Enhanced Usual Care Group were not asked to attend intervention sessions.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '210.4', 'spread': '32.4', 'groupId': 'OG000'}, {'value': '229.5', 'spread': '34.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '133.4', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '133.8', 'spread': '13.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.9', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '82.3', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'In order to assess the feasibility of collecting this data from the medical record, the proportion of participants for whom this data is available at 6-months post-randomization (+/- 90 days) will be reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'In order to assess the feasibility of collecting this data from the medical record, the proportion of participants for whom this data is available at 6-months post-randomization (+/- 90 days) will be reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cholesterol (Lipid Panel)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'FG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '26 randomized, however, one had to withdraw pre-intervention initiation due to cancer diagnosis.', 'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Intervention Start', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Cancer diagnosis prior intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Declined in-person follow-up visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Of 118 enrolled participants, 58 met inclusion criteria.\n\n51 participants were randomized. 1 had to withdraw pre-intervention initiation due to cancer diagnosis.\n\n50 participants were randomized and received the intervention treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator\n\nHELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.'}, {'id': 'BG001', 'title': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter\n\nIndividual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '64.2', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '222.8', 'spread': '32.6', 'groupId': 'BG000'}, {'value': '231.9', 'spread': '30.5', 'groupId': 'BG001'}, {'value': '227.3', 'spread': '31.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '133.5', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '132.8', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '133.2', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '80.8', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '80.9', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Glucose', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'In order to assess the feasibility of collecting this data from the electronic medical record, the proportion of participants for whom this data is available at randomization (+/- 90 days) will be reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Cholesterol (Lipid Panel)', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'In order to assess the feasibility of collecting this data from the medical record, the proportion of participants for whom this data is available at randomization (+/- 90 days) will be reported.', 'unitOfMeasure': 'Participants'}], 'populationDescription': '26 participants were randomized to the lifestyle weight loss intervention; however, one had to withdraw soon after randomization and before intervention initiation due to a cancer diagnosis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-08', 'size': 174805, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-05-08T10:41', 'hasProtocol': False}, {'date': '2018-08-08', 'size': 656275, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-26T10:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2016-07-13', 'resultsFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2016-07-15', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-02', 'studyFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Weight', 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.'}, {'measure': 'Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization', 'timeFrame': '6 months', 'description': 'In order to assess the feasibility of collecting this data from the medical record, the proportion of participants for whom this data is available at 6-months post-randomization (+/- 90 days) will be reported.'}, {'measure': 'Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization', 'timeFrame': '6 months', 'description': 'In order to assess the feasibility of collecting this data from the medical record, the proportion of participants for whom this data is available at 6-months post-randomization (+/- 90 days) will be reported.'}, {'measure': 'Fasting Glucose', 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.'}, {'measure': 'Cholesterol (Lipid Panel)', 'timeFrame': '6 months', 'description': 'The means and standard deviations at 6 months will be calculated.'}], 'primaryOutcomes': [{'measure': 'Recruitment of Study Participants', 'timeFrame': '6 months', 'description': 'To characterize the ability to recruit Veterans to participate in this pilot study, the proportion of Veterans screened who are eligible to participate and the proportion of eligible participants who agree to participate will be calculated. The rate of referrals to the program by providers in the local community-based outpatient clinic will also be monitored.'}, {'measure': 'Retention of Study Participants', 'timeFrame': '6 months', 'description': 'To characterize the ability to retain Veterans in this pilot study, the percentage of participants who complete the study (attendance at the 6-month assessment visit) as a measure of overall study retention will be calculated.'}, {'measure': 'Adherence to the Lifestyle Weight Loss Intervention', 'timeFrame': '6 months', 'description': 'The proportion of intervention sessions attended will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-diabetes', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Diabetes and obesity are both major public health concerns and the prevalence of diabetes is even higher in the patient population of the Veterans Administration. This planning project is designed to adapt a successful weight-loss program for delivery through an existing outpatient clinic to reach local Veterans at risk for developing diabetes. The information gathered as a part of this project will be used to plan a larger trial designed to improve the health of Veterans by offering them a diabetes prevention program through their usual source of healthcare.', 'detailedDescription': 'Type II diabetes and its complications disproportionately affect the patient population served by the Department of Veterans Affairs (VA). Recent lifestyle interventions have demonstrated that weight-loss achieved through reductions in calorie intake and increases in physical activity can prevent or delay the onset of diabetes. The Healthy Living Partnerships to Prevent Diabetes (HELP PD), a community-based adaptation of the lifestyle intervention used in the Diabetes Prevention Program, achieved more than a 7% weight loss at 6 months.\n\nIn HELP Vets, researchers will test the feasibility of further translating the HELP PD lifestyle intervention, tailored for use in the Veteran population, in the Kernersville Community-Based Outpatient Clinic operated by the VA. The investigators plan to recruit 50 overweight or obese Veterans at high risk for developing diabetes from the existing patient population to participate in a 6-month weight loss intervention led by community health workers who are also Veterans. As VA outpatient clinics have the requisite infrastructure to identify, screen, and enroll participants and access to Veteran community health workers from within their patient populations, they are ideal potential homes for diabetes prevention programming. Data gathered during this planning grant will be used to develop a large-scale study to test implementing the HELP Vets intervention in a larger segment of the Veteran population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 25-40 kg/m2\n* Evidence of Pre-Diabetes: all participants will be required to qualify based on evidence of prediabetes from fasting plasma glucose, oral glucose tolerance test, or hemoglobin A1c (HbA1c) taken in the three months.\n* The appropriate ranges for each test are\n* Hemoglobin A1c (HbAlc): 5.7 to 6.4%\n* Fasting Plasma Glucose: 95-125 mg/dL\n* Oral Glucose Tolerance Test: 140-200 mg/dL.\n* Blood measures will be collected from the medical record\n* Prospective participants must be willing to accept randomization to either the lifestyle intervention or the enhanced usual care condition.\n\nExclusion Criteria:\n\n* Currently involved in a supervised program for weight loss\n* Clinical history of diabetes\n* Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure\n* Uncontrolled high blood pressure (BP \\> 160/100) Potential participants can be re-screened after controlled\n* Pregnancy, planning pregnancy and breast feeding (self-report) during screening; Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer\n* Chronic use of medicine known to significantly affect glucose metabolism (e.g., corticosteroids, protease inhibitors)\n* Other conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP Vets, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), participation in another research study that would interfere with HELP Vets.'}, 'identificationModule': {'nctId': 'NCT02835495', 'acronym': 'HELP Vets', 'briefTitle': 'Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study', 'orgStudyIdInfo': {'id': 'IRB00033688'}, 'secondaryIdInfos': [{'id': 'R34DK108100', 'link': 'https://reporter.nih.gov/quickSearch/R34DK108100', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle Weight Loss', 'description': 'Behavioral: HELP Vets Intervention\n\nLifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator', 'interventionNames': ['Behavioral: HELP Vets Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': 'Behavioral: Individual Education Program\n\nStandard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter', 'interventionNames': ['Behavioral: Individual Education Program']}], 'interventions': [{'name': 'HELP Vets Intervention', 'type': 'BEHAVIORAL', 'description': 'This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.', 'armGroupLabels': ['Lifestyle Weight Loss']}, {'name': 'Individual Education Program', 'type': 'BEHAVIORAL', 'description': 'Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.', 'armGroupLabels': ['Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'W.G. "Bill" Hefner VA Medical Center', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Mara Z Vitolins, DrPH MPH RDN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}