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

NCT01901367 | Completed DMC

• 5 other identifiers: VICC PED 1309P30 CA 68485 OD2K12CA090625-11- A)2K12CA090625-11P30CA068485
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Acute Lymphoblastic Leukemia in Remission

Keywords

Adiponectin, Glucose, Insulin, Leptin

Outcome Measures

Primary Outcomes (1)

• Percentage change in number of pediatric ALL patients with BMI ≥ 75th percentile who agree to be randomized to participate in a lifestyle intervention program.

  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

  Baseline and at 6 months

Secondary Outcomes (1)

• 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

  At 3 months and at 6 months

Study Arms (2)

Arm I (intervention)

EXPERIMENTAL

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; Behavioral: exercise intervention; Other: follow-up care; Behavioral: counseling intervention; Other: quality-of-life assessment; Other: laboratory biomarker analysis; Other: questionnaire administration

Arm II (control)

NO INTERVENTION

Patients receive standard of care individualized diet and exercise plan

Interventions

nutritional intervention DIETARY_SUPPLEMENT

Receive nutritional intervention

Arm I (intervention)

exercise intervention BEHAVIORAL

Receive exercise intervention

Arm I (intervention)

follow-up care OTHER

Receive booster follow-up sessions from the nutritionist and exercise physiologist

Arm I (intervention)

counseling intervention BEHAVIORAL

Receive phone counseling with a trained health coach

Also known as: counseling and communications studies

Arm I (intervention)

quality-of-life assessment OTHER

Ancillary studies

Arm I (intervention)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (intervention)

questionnaire administration OTHER

Ancillary studies

Arm I (intervention)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Aftercare; Counseling

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services

Study Officials

• Adam Esbenshade, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatric Hematology

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 17, 2013
• Study Start: May 1, 2013
• Primary Completion: September 30, 2014
• Study Completion: September 1, 2015
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

US (1)