Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors

Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02815982

Acronym

NOURISH-T

Enrollment

106

Registered

2016-06-28

Start date

2013-12-31

Completion date

2016-12-31

Last updated

2018-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Obesity

Brief 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).

Detailed description

Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese, which increases their risk for negative long-term physical health complications. Consistent with the Institute of Medicine's (IOM) emphasis on patients transitioning from treatment to cancer survivorship and increasing long-term healthy behaviors in these survivors, we conducted a pilot RCT to address the increasing overweight/obesity rates among PCS by targeting their caregivers as agents for PCS behavior change. We focused on parents' behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in PCS and adapted an evidence-informed, manualized parent intervention - NOURISH - found to be effective for parents of overweight and obese children and adolescents in reducing child and adolescent BMI. We adapted NOURISH for caregivers of 5 - 13 year old PCS (6 months -4 years off active cancer treatment). Our pilot feasibility RCT - NOURISH-T (Nourishing Our Understanding of Role modeling to Improve Support for Healthy Transitions) evaluates: 1) the preliminary feasibility efficacy of NOURISH-T for PCS, compared with an Enhanced Usual Care (EUC) control condition, and 2) factors to consider to improve future adaptations of the intervention. The project enrolled caregivers of PCS at two pediatric oncology clinics into the 6-week intervention (or EUC) with assessments of both caregivers and PCS occurring pre- and post-6 weeks of intervention, and at a 4-month follow-up. In comparison to EUC, we hypothesized that caregivers and PCS assigned to the NOURISH-T condition would show greater improvements in dietary intake, physical activity, and in anthropometric health indicators over time.

Interventions

BEHAVIORALNOURISH-T

Overweight/obesity family intervention

BEHAVIORALEnhanced Usual Care

Publicly available overweight/obesity materials

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 13 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE	6 weeks	At the end of the final session (6-sessions), caregivers completed a likert-type survey assessing what they liked/disliked about the intervention, as well as what was/was not useful or helpful in reaching health goals. Eleven items were summed to obtain a total continuous composite satisfaction/liking score. Each item was measured on a likert scale ranging from strongly disagree (=1) to strongly agree (=5). The scale sum score ranged from 11 to 55 with higher scores indicating greater satisfaction with the intervention. More specifically, the higher the score, the more useful the caregiver thought the intervention and the more they liked participating in the intervention. Lower scores indicate that the caregiver thought the program was not useful and they did not like participating.

Secondary

Measure	Time frame	Description
Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)	Continuous child BMI percentile as a function of gender and age. This measure was obtained via the PCS medical chart.
Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)	This 8-item questionnaire was completed by the pediatric cancer survivor and assessed child intake of sugar sweetened beverages, breakfast and dinner habits, as well as frequency of fast food intake. The sum score represents the total number of sugary beverages consumed and the number of times consuming fast food in the prior week. Higher scores indicate greater consumption of sugary beverages and fast food in the prior week. The sum score could range from 0 and has no upper limit.
Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)	This 31-item questionnaire assesses parental approaches to and attitudes about feeding their children. Sub-scales include concerns about child weight, monitoring, restriction, and pressure to eat. The sum score of the Likert items ranged from 31 to 155 with higher scores indicating greater perceived concern, monitoring, restriction and pressure to eat.
Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)	PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week.
Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)	A 24-hour recall was completed by caregivers using the Automated Self-administered 24-Hour Dietary Recall-2011 (adult version) at pre-intervention, post-intervention (6-weeks) and at 4 months follow-up. The outcome was measured as the number of calories consumed over 1-day. Caregivers reported detailed information on the foods consumed and quantity including the method used for preparation, portion sizes, and where the food was purchased using visual cues in the previous day through the ASA24 website (https://asa24.nci.nih.gov/). The website reported the total number of calories consumed based on the data input.
Parent BMI Score -- CAREGIVER MEASURE	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)	Measured at the clinic via standardized equipment.
Parent Waist to Hip Ratio -- CAREGIVER MEASURE	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)	Measured at the clinic via standardized equipment
Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)	PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week.
Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)	Measured at the clinic via standardized equipment.

Countries

United States

Participant flow

Recruitment details

Caregivers and PCS were recruited as dyads, however, caregivers participated in the intervention (NOURISH-T vs EUC) and completed measures. PCS did not participate in the intervention and only completed measures. Outcomes are noted by whether caregivers or PCS completed measures.

Participants by arm

Arm	Count
NOURISH-T - Caregivers The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the identified patient or overweight child. NOURISH-T: Overweight/obesity family intervention	27
NOURISH-T - Pediatric Cancer Survivors (PCS) The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the identified patient or overweight child. NOURISH-T: Overweight/obesity family intervention	27
Enhanced Usual Care - Caregivers Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period. Enhanced Usual Care: Publicly available overweight/obesity materials	26
Enhanced Usual Care - Pediatric Cancer Survivors (PCS) Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period. Enhanced Usual Care: Publicly available overweight/obesity materials	26
Total	106

Baseline characteristics

Characteristic	NOURISH-T - Caregivers	NOURISH-T - Pediatric Cancer Survivors (PCS)	Enhanced Usual Care - Caregivers	Enhanced Usual Care - Pediatric Cancer Survivors (PCS)	Total
Age, Categorical <=18 years	0 Participants	27 Participants	0 Participants	26 Participants	53 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	27 Participants	0 Participants	26 Participants	0 Participants	53 Participants
Age, Continuous all Participants	38.0 years STANDARD_DEVIATION 8.4	9.48 years STANDARD_DEVIATION 2.8	41.5 years STANDARD_DEVIATION 9.2	10.48 years STANDARD_DEVIATION 2.79	24.87 years STANDARD_DEVIATION 5.8
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	4 Participants	4 Participants	4 Participants	16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants	20 Participants	17 Participants	17 Participants	74 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants	3 Participants	5 Participants	5 Participants	16 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants	6 Participants	8 Participants	8 Participants	28 Participants
Race (NIH/OMB) White	20 Participants	20 Participants	17 Participants	17 Participants	74 Participants
Region of Enrollment United States	27 participants	27 participants	26 participants	26 participants	106 participants
Sex: Female, Male Female	21 Participants	13 Participants	19 Participants	15 Participants	68 Participants
Sex: Female, Male Male	6 Participants	14 Participants	7 Participants	11 Participants	38 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 27	0 / 26	0 / 27	0 / 26
serious Total, serious adverse events	0 / 27	0 / 26	0 / 27	0 / 26

Outcome results

Primary

Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE

At the end of the final session (6-sessions), caregivers completed a likert-type survey assessing what they liked/disliked about the intervention, as well as what was/was not useful or helpful in reaching health goals. Eleven items were summed to obtain a total continuous composite satisfaction/liking score. Each item was measured on a likert scale ranging from strongly disagree (=1) to strongly agree (=5). The scale sum score ranged from 11 to 55 with higher scores indicating greater satisfaction with the intervention. More specifically, the higher the score, the more useful the caregiver thought the intervention and the more they liked participating in the intervention. Lower scores indicate that the caregiver thought the program was not useful and they did not like participating.

Time frame: 6 weeks

Population: Independent Samples T-Test

Arm	Measure	Value (MEAN)	Dispersion
NOURISH-T	Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE	46.2 units on a scale	Standard Deviation 5.1
Enhanced Usual Care	Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE	37.5 units on a scale	Standard Deviation 8.1

p-value: <0.0595% CI: [-14.6, -2.7]t-test, 2 sided

Secondary

Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE

A 24-hour recall was completed by caregivers using the Automated Self-administered 24-Hour Dietary Recall-2011 (adult version) at pre-intervention, post-intervention (6-weeks) and at 4 months follow-up. The outcome was measured as the number of calories consumed over 1-day. Caregivers reported detailed information on the foods consumed and quantity including the method used for preparation, portion sizes, and where the food was purchased using visual cues in the previous day through the ASA24 website (https://asa24.nci.nih.gov/). The website reported the total number of calories consumed based on the data input.