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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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 \[BMI\] \>= 50th 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.

Conditions

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Childhood Acute Lymphoblastic Leukemia in Remission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

nutritional intervention

Intervention Type DIETARY_SUPPLEMENT

Receive nutritional intervention

exercise intervention

Intervention Type BEHAVIORAL

Receive exercise intervention

follow-up care

Intervention Type OTHER

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

counseling intervention

Intervention Type BEHAVIORAL

Receive phone counseling with a trained health coach

quality-of-life assessment

Intervention Type OTHER

Ancillary studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

Arm II (control)

Patients receive standard of care individualized diet and exercise plan

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nutritional intervention

Receive nutritional intervention

Intervention Type DIETARY_SUPPLEMENT

exercise intervention

Receive exercise intervention

Intervention Type BEHAVIORAL

follow-up care

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

Intervention Type OTHER

counseling intervention

Receive phone counseling with a trained health coach

Intervention Type BEHAVIORAL

quality-of-life assessment

Ancillary studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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counseling and communications studies

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No