Clinical trial · Interventional
ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Lymphoblastic Leukemia in Remission | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Behavioral | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| follow-up care | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| nutritional intervention | Dietary Supplement | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (intervention)
- description
- 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.
- interventionNames
- 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
- type
- NO_INTERVENTION
- label
- Arm II (control)
- description
- Patients receive standard of care individualized diet and exercise plan
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available