ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - 18 |
| Updated: | 5/10/2018 |
| Start Date: | May 2013 |
| End Date: | September 2015 |
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.
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] >= 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.
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.
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.
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