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Completed

NCT Number: NCT02815982

Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors

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).

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Key information

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins All Children's Hospital, St. Petersburg, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOURISH-T

Behavioral

Overweight/obesity family intervention

Enhanced Usual Care

Behavioral

Publicly available overweight/obesity materials

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)

    Time frame: 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.

  3. Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure

    Time frame: 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.

  4. Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE

    Time frame: 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.

  5. Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed

    Time frame: 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.

  6. Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED

    Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

    Measured at the clinic via standardized equipment.

  7. Parent BMI Score -- CAREGIVER MEASURE

    Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

    Measured at the clinic via standardized equipment.

  8. Parent Waist to Hip Ratio -- CAREGIVER MEASURE

    Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

    Measured at the clinic via standardized equipment

  9. Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Johns Hopkins All Children's Hospital
  • University of Pittsburgh

Registry information

Official study title

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

Acronym: NOURISH-T

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 28, 2016
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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