N/A N=106 Randomized Treatment

Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors

Obesity · Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02815982 ↗

Enrolled (actual)

106

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcome: Primary: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE — 46.2; 37.5 units on a scale — p=<.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NOURISH-T (Behavioral); Enhanced Usual Care (Behavioral)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: University of South Florida
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE	46.2; 37.5	<.05 sig
SECONDARY Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE	1928.9; 1802.0; 1830.8; 1866.4; 1732.6; 2012.2	<.001 sig
SECONDARY Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)	95.3; 95.9; 95.2; 95.7; 94.8; 93.4	<.001 sig
SECONDARY Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure	9.4; 9.5; 7.8; 7.7; 5.1; 7.3	<.03 sig
SECONDARY Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE	97.3; 96.7; 95; 98.5; 95.2; 92.3	<.09
SECONDARY Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed	5695.5; 6568.4; 6279.4; 5950.8; 7162.6; 8674.7	<.08
SECONDARY Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED	.94; .97; .93; .98; .92; .99	<.0001 sig
SECONDARY Parent BMI Score -- CAREGIVER MEASURE	32.9; 32.1; 33.2; 30.3; 32.4; 32.5	<.001 sig
SECONDARY Parent Waist to Hip Ratio -- CAREGIVER MEASURE	.94; .91; .90; .91; .90; .94	<.001 sig
SECONDARY Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE	7016.7; 6288.3; 5439.0; 5090.1; 7087.4; 5891.2	<.12

Summary

This purpose of this pilot study is to investigate the feasibility of and optimal time post cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T), as well as assess its preliminary efficacy on specific child health behaviors. The study will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC (standard care).

Eligibility Criteria

Inclusion Criteria

Caregivers

Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric cancer survivors
18 years or older
Fluent in English

Pediatric Cancer Survivors

Diagnosis of cancer
between 5-13 years of age at study entry
off active cancer treatment for 6 months to 4 years,
reside with a participating caregiver
able to engage in PA tailored to current medical status
NOT taking medications that affect body weight, e.g., steroids within 6 months of enrollment
at or above the 85th BMI %ile.

Exclusion Criteria

Caregivers

are non-ambulatory
do not reside with the PCS at least 50% of the time.

Pediatric cancer survivor

relapse during the intervention
taken a medication known to affect body weight such as oral steroids or antipsychotic medications within 6 months of enrollment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02815982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.