ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Adam Esbenshade, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01901367
First received: July 2, 2013
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Childhood Acute Lymphoblastic Leukemia in Remission
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Percentage change in number of pediatric ALL patients with BMI ≥ 75th percentile who agree to be randomized to participate in a lifestyle intervention program. [ Time Frame: Baseline and at 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 [ Time Frame: At 3 months and at 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (intervention)
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.
Dietary Supplement: nutritional intervention
Receive nutritional intervention
Behavioral: exercise intervention
Receive exercise intervention
Other: follow-up care
Receive booster follow-up sessions from the nutritionist and exercise physiologist
Behavioral: counseling intervention
Receive phone counseling with a trained health coach
Other Name: counseling and communications studies
Other: quality-of-life assessment
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
No Intervention: Arm II (control)
Patients receive standard of care individualized diet and exercise plan

Detailed Description:

PRIMARY OBJECTIVES:

I. 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] >= 75th percentile).

II. 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.

III. Assess changes in serum glucose, insulin, leptin and adiponectin in patients over the intervention course and at 3 months post intervention.

IV. 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.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 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.

ARM II: Patients receive standard of care individualized diet and exercise plan.

After completion of study treatment, patients are followed up at 3 and 6 months.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • English speaking patient and primary caregiver
  • 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)
  • Provision of informed consent by primary caregiver

Exclusion Criteria:

  • Any physical or mental limitation that would prevent participation in study activities (Including but not limited to grade 4 neuropathy or inability to ambulate)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901367

Contacts
Contact: Clinical Trials Information Program 800-811-8480

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Trials Information Program    800-811-8480      
Contact: Renee Ashworth    (615) 322-3206      
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Adam Esbenshade, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Adam Esbenshade, Assistant Professor, Pediatric Hematology, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01901367     History of Changes
Other Study ID Numbers: VICC PED 1309, P30 CA 68485 OD, 2K12CA090625-11- A)
Study First Received: July 2, 2013
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt-Ingram Cancer Center:
Adiponectin, Glucose, Insulin, Leptin

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014