Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT01901367
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2013-07-12', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in number of pediatric ALL patients with BMI ≥ 75th percentile who agree to be randomized to participate in a lifestyle intervention program.', 'timeFrame': 'Baseline and at 6 months', 'description': 'Patients undergo a nutrition and counseling intervention designed to decrease their calorie intake, meet micronutrient recommendations, and participate in an exercise plan. Feasibility is defined as \\>50% of patients who complete the intervention'}], 'secondaryOutcomes': [{'measure': 'Percentage of increase or decrease in BMI of pediatric ALL patients with a BMI > 75th percentile who undergo a nutrition and counseling intervention compared to a control group of pediatric ALL patients who do not undergo intervention', 'timeFrame': 'At 3 months and at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adiponectin, Glucose, Insulin, Leptin'], 'conditions': ['Childhood Acute Lymphoblastic Leukemia in Remission']}, 'descriptionModule': {'briefSummary': 'This randomized pilot phase II trial studies how well nutritional intervention and exercise intervention works in preventing metabolic syndrome in younger patients with acute lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of being tired caused by cancer, may help improve strength, and may help build up lost muscle tissue. Nutritional intervention plus exercise intervention may be effective at preventing metabolic syndrome.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate feasibility, adherence, completion rates and participant satisfaction associated with a family based lifestyle intervention for overweight pediatric acute lymphoblastic leukemia (ALL) patients or those at high risk to become so (body mass index \\[BMI\\] \\>= 50th percentile).\n\nII. Assess changes in BMI z-score, waist circumference, body composition, blood pressure exercise tolerance and physical activity at baseline, immediately post intervention and three months later.\n\nIII. Assess changes in serum glucose, insulin, leptin and adiponectin in patients over the intervention course and at 3 months post intervention.\n\nIV. Assess changes in self-reported quality of life, physical activity, caloric intake, and fatigue associated with the nutrition and exercise program in the participant and their primary caregiver.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive standard of care individualized diet and exercise plan and monthly booster follow-up sessions from the nutritionist and exercise physiologist and weekly phone counseling with a trained health coach to address barriers to improve plan adherence.\n\nARM II: Patients receive standard of care individualized diet and exercise plan.\n\nAfter completion of study treatment, patients are followed up at 3 and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of pre-B cell or T cell ALL and in continuous first remission; at least 3 months into maintenance therapy with at least 7 months remaining before therapy completion\n* English speaking patient and primary caregiver\n* BMI \\>= 75th percentile at time of study enrollment; (patients \\>= 75th percentile were selected as they were the group in our preliminary data that had a high risk of becoming overweight during maintenance therapy)\n* Provision of informed consent by primary caregiver\n\nExclusion Criteria:\n\n* Any physical or mental limitation that would prevent participation in study activities (Including but not limited to grade 4 neuropathy or inability to ambulate)\n* As this is intended to be a family-based intervention, all family members will be invited to participate, including those living in more than one household, however endpoints will only be assessed formally in the patient and identified primary caregiver; siblings are not required for participation.'}, 'identificationModule': {'nctId': 'NCT01901367', 'briefTitle': 'ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients', 'orgStudyIdInfo': {'id': 'VICC PED 1309'}, 'secondaryIdInfos': [{'id': 'P30 CA 68485 OD', 'type': 'OTHER_GRANT', 'domain': 'National Cancer Institute'}, {'id': '2K12CA090625-11- A)', 'type': 'OTHER', 'domain': 'RAC'}, {'id': '2K12CA090625-11', 'link': 'https://reporter.nih.gov/quickSearch/2K12CA090625-11', 'type': 'NIH'}, {'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (intervention)', 'description': 'Patients receive standard of care individualized diet and exercise plan and monthly booster follow-up sessions from the nutritionist and exercise physiologist and weekly phone counseling with a trained health coach to address barriers to improve plan adherence.', 'interventionNames': ['Dietary Supplement: nutritional intervention', 'Behavioral: exercise intervention', 'Other: follow-up care', 'Behavioral: counseling intervention', 'Other: quality-of-life assessment', 'Other: laboratory biomarker analysis', 'Other: questionnaire administration']}, {'type': 'NO_INTERVENTION', 'label': 'Arm II (control)', 'description': 'Patients receive standard of care individualized diet and exercise plan'}], 'interventions': [{'name': 'nutritional intervention', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Receive nutritional intervention', 'armGroupLabels': ['Arm I (intervention)']}, {'name': 'exercise intervention', 'type': 'BEHAVIORAL', 'description': 'Receive exercise intervention', 'armGroupLabels': ['Arm I (intervention)']}, {'name': 'follow-up care', 'type': 'OTHER', 'description': 'Receive booster follow-up sessions from the nutritionist and exercise physiologist', 'armGroupLabels': ['Arm I (intervention)']}, {'name': 'counseling intervention', 'type': 'BEHAVIORAL', 'otherNames': ['counseling and communications studies'], 'description': 'Receive phone counseling with a trained health coach', 'armGroupLabels': ['Arm I (intervention)']}, {'name': 'quality-of-life assessment', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (intervention)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (intervention)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Adam Esbenshade, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Pediatric Hematology', 'investigatorFullName': 'Adam Esbenshade', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}