Clinical trial · Interventional
Let's Play! Healthy Kids After Cancer
Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention
NCT02361047CI-TRIAL-00039009completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 pilot study will evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.
Conditions
Conditions (2)
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 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phone Coaching Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phone Coaching Program
- description
- Participants will receive a nutrition and physical activity phone coaching program, in addition to standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
- interventionNames
- Behavioral: Phone Coaching Program
- type
- NO_INTERVENTION
- label
- Standard Care Control
- description
- Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
Primary outcomes (3)
- measure
- Feasibility: Number of participants who complete 8 of 10 intervention sessions
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 10 Years
Show eligibility criteria text
Inclusion Criteria: * Between 4.0 years and \< 11.0 years of age at the time of recruitment * Previously diagnosed of ALL and currently in remission * Between 1-5 years post completion of chemotherapy * BMI ≥ 85 percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2) Exclusion Criteria: * History of cranial radiation therapy * History of bone marrow transplant * History of relapse of ALL * Diagnosis of Down's Syndrome * Comorbidities of obesity that require immediate subspecialist referral * Significant pulmonary, cardiovascular, orthopedic, or musculoskeletal problems that would, in their oncologist's judgment, limit their ability to participate in physical activity * Significant psychiatric or neurologic disorders that would impair compliance with study protocol * Current participation in a weight-loss program
References
Publications (6)
- BACKGROUNDRogers PC, Meacham LR, Oeffinger KC, Henry DW, Lange BJ. Obesity in pediatric oncology. Pediatr Blood Cancer. 2005 Dec;45(7):881-91. doi: 10.1002/pbc.20451. PMID 16035086
- BACKGROUNDNess KK, Armenian SH, Kadan-Lottick N, Gurney JG. Adverse effects of treatment in childhood acute lymphoblastic leukemia: general overview and implications for long-term cardiac health. Expert Rev Hematol. 2011 Apr;4(2):185-97. doi: 10.1586/ehm.11.8. PMID 21495928
- BACKGROUNDNess KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209. PMID 19224548
- BACKGROUNDCohen J, Wakefield CE, Fleming CA, Gawthorne R, Tapsell LC, Cohn RJ. Dietary intake after treatment in child cancer survivors. Pediatr Blood Cancer. 2012 May;58(5):752-7. doi: 10.1002/pbc.23280. Epub 2011 Aug 17. PMID 21850679
- BACKGROUNDMayer EI, Reuter M, Dopfer RE, Ranke MB. Energy expenditure, energy intake and prevalence of obesity after therapy for acute lymphoblastic leukemia during childhood. Horm Res. 2000;53(4):193-9. doi: 10.1159/000023566. PMID 11044803
- BACKGROUNDSherwood NE, Levy RL, Langer SL, Senso MM, Crain AL, Hayes MG, Anderson JD, Seburg EM, Jeffery RW. Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds. Contemp Clin Trials. 2013 Sep;36(1):228-43. doi: 10.1016/j.cct.2013.06.017. Epub 2013 Jun 28. PMID 23816490