Clinical trial · Interventional
PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
NCT01253720CI-TRIAL-00020670completedN/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)
UC San Diego researchers conducted a study to develop and evaluate an internet and text message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors. We hypothesized that those study participants randomized to the intervention will demonstrate greater reduction in BMI-z score as compared to the control group.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PACE CALL/Fit4Life | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PACE CALL/Fit4Life
- description
- Fit4Life intervention activities: Website: Provides weekly nutrition, physical activity, and weight loss information. Counseling Calls: Participants and their parents will get phone calls from their Health Coach to assess progress \& problems. Health Coach Question \& Answer: Participants will be assigned a Health Coach that they can contact at any time to ask questions or express any concerns. Text \& Picture Messages: Participants will receive daily text messages to help remind them of being healthy. Messages will relate to the weekly topics and general checking in questions. Parent Materials: Parents will receive a packet of printed materials that relate to parenting skills regarding being a healthy role model for their child and healthy eating and exercise tips.
- interventionNames
- Behavioral: PACE CALL/Fit4Life
- type
- NO_INTERVENTION
- label
- Control
- description
- The Control group will receive monthly mailings on basic nutrition and physical activity information.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 7 - 18 years old * survived childhood acute lymphoblastic leukemia (defined as being off treatment for at least 2 years) * greater than or equal to 85th percentile BMI-for-age and gender) * read and speak English * have a parent that reads and speaks English or Spanish * willingness to attend assessments * access to the Internet Exclusion Criteria: * any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome * any subject with a known disease of the liver, pancreas or small intestine that would adversely effect digestion or absorption of nutrients * any pulmonary, cardiovascular, orthopedic, or musculoskeletal problem that would limit ability to adhere to moderate-level physical activity recommendations * have a history of substance abuse or other psychiatric disorder that would impair compliance with the study protocol * are using any medications which alter body weight * are currently enrolled in another weight loss program * in foster care
References
Publications (1)
- RESULTHuang JS, Dillon L, Terrones L, Schubert L, Roberts W, Finklestein J, Swartz MC, Norman GJ, Patrick K. Fit4Life: a weight loss intervention for children who have survived childhood leukemia. Pediatr Blood Cancer. 2014 May;61(5):894-900. doi: 10.1002/pbc.24937. Epub 2014 Jan 16. PMID 24436138