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

This study is currently recruiting participants.
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

July 2, 2013
July 12, 2013
May 2013
March 2016   (final data collection date for primary outcome 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. [ 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
Same as current
Complete list of historical versions of study NCT01901367 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients
ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Childhood Acute Lymphoblastic Leukemia in Remission
  • 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
  • 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.
    Interventions:
    • 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
  • No Intervention: Arm II (control)
    Patients receive standard of care individualized diet and exercise plan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2016
March 2016   (final data collection date for primary outcome measure)

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.
Both
2 Years to 18 Years
No
Contact: Clinical Trials Information Program 800-811-8480
United States
 
NCT01901367
VICC PED 1309, P30 CA 68485 OD, 2K12CA090625-11- A)
Yes
Adam Esbenshade, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Adam Esbenshade, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP