NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors (NOURISH-T+)

September 26, 2023 updated by: University of South Florida

NOURISH-T+: A Randomized Control Trial Targeting Parents in Promoting Healthy Eating and Exercise Behaviors in Pediatric Cancer Survivors With Overweight/Obesity

Pediatric cancer survivors are at an increased risk of excessive weight gain and reduced exercise behaviors with the potential for this risk to worsen over time. With over 80% of pediatric cancer patients living to adulthood, many pediatric cancer survivors experience long-term health consequences such as heart disease - the leading cause of death in this population.

The purpose of this clinical research study is to teach parents/caregivers skills that will help prevent and reduce the problems of obesity in childhood cancer survivors. In this study, parents have the opportunity to participate in one of two web-based groups in which parents in either group will learn valuable information to improve the health of their child and of themselves.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This project employs a cluster randomized, controlled, repeated measures trial study design, with parent-child dyads assigned to an evidence-informed manualized, social-cognitive parent intervention (NOURISH-T+) or to a comparison group (Enhanced Usual Care group - Brief NOURISH-T+). NOURISH-T+ stands for Nourishing Our Understanding of Role modeling to Improve Support and Health for Healthy Transitions.

Parents of pediatric cancer survivors (ages 5-14 years) with overweight and obesity, and off treatment for at least 6 months will be recruited across multiple pediatric oncology clinic sites. The University of South Florida (USF) serves as the coordinating data management and centralized research and intervention team and will also recruit eligible participants from its pediatric oncology clinic.

NOURISH-T+ targets parents as agents of change by providing intensive parent skills training emphasizing role modeling of positive health behaviors to foster the development of healthy eating and physical activity in pediatric cancer survivors. The NOURISH-T+ group will have 6 weekly, 1-1.5 hour, manualized sessions delivered using video-conferencing. There will be 2 additional brief sessions where the child will participate along with their parent to promote child engagement. Additionally, there will be one session with a pediatric oncology dietician based out of Nicklaus Children's Hospital who will discuss personalized nutritional strategies. Brief booster sessions at 2-, 4-, 8-, and 10- months will maximize retention and follow-up participation. NOURISH-T+ content is theory-based, manualized, and builds upon strengths of our prior work with NOURISH-T (our pilot) and NOURISH (our work with otherwise healthy overweight and obese children).

Parents randomized to Brief NOURISH-T+ will participate in one information session moderated by a USF-based interventionist using videoconferencing. Session content is taken from the publicly available We Can! Manual. Parents in this group will receive nationally available web-based brochures on pediatric overweight/obesity on two occasions during the 6 weeks that NOURISH-T+ families participate in the study. Check-ins will take place at 2-, 4-, 8-, and 10- months post-intervention.

Outcome measures will be completed at baseline, 3-, 6-, and 12-months post-intervention.

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marilyn Stern, PhD
  • Phone Number: 813-974-0966
  • Email: mstern1@usf.edu

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Suspended
        • Children's National Hospital
    • Florida
      • Gainesville, Florida, United States, 32611
      • Miami, Florida, United States, 33155
        • Suspended
        • Nicklaus Children's Hospital
      • Miami, Florida, United States, 33136
      • Tampa, Florida, United States, 33612
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kathy Ruble, PhD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Suspended
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Eligible Pediatric Cancer Survivors must be:

  1. 5-14 years of age at enrollment;
  2. Off active treatment for at least 6 months;
  3. At or above the 85th BMI %ile;
  4. Able to complete assessments with the help of clinic staff and the USF research team;
  5. Residing with the participating parent;
  6. Able to engage in PA tailored to current medical status;
  7. NOT taking medications that affect body weight (e.g., steroids) within 6 months of enrollment, and
  8. In remission -- PCS who experience a relapse of cancer during the intervention will be excused from further involvement.
  9. Must be English- or Spanish-speaking

Participating Parents must:

  • Be either biological or adoptive and/or step mothers or fathers and must be permanent legal guardians of the PCS
  • Be at least 18 years old
  • Identifies as the main meal preparer at home
  • Must be English- or Spanish-speaking

Exclusion Criteria:

  • Parents are ineligible if they are non-ambulatory and/or do not reside at least 50% of the time with their participating child.
  • Female parents who are currently pregnant will be excluded from the study.
  • Children are ineligible to participate if they are non-ambulatory. In addition, children who are wards of the state will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NOURISH-T+
NOURISH-T+ targets parents as agents of change by providing intensive parent skills training emphasizing role modeling of positive health behaviors to foster the development of healthy eating and physical activity in pediatric cancer survivors. The NOURISH-T+ group will have 6 weekly, 1-1.5 hour, manualized sessions delivered using video-conferencing. There will be 2 additional brief sessions where the child will participate along with their parent to promote child engagement. Additionally, there will be one session with a pediatric oncology dietician based out of Nicklaus Children's Hospital who will discuss personalized nutritional strategies. Brief booster sessions at 2-, 4-, 8-, and 10- months will maximize retention and follow-up participation. NOURISH-T+ content is theory-based, manualized, and builds upon strengths of our prior work with NOURISH-T (our pilot) and NOURISH (our work with otherwise healthy overweight and obese children).
Behavioral: NOURISH-T+
NOURISH-T+ (Nourishing Our Understanding of Role Modeling to Improve Support and Healthy - Transitions) is a 6 session, psychoeducational program designed to teach parents of childhood cancer survivors with overweight/obesity knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.
Active Comparator: EUC - Brief NOURISH-T+
The EUC condition (Brief NOURISH-T+) engages parents in one information session moderated by a USF-based interventionist using videoconferencing. Session content is taken from the publicly available We Can! Manual. Parents in this group will receive nationally available web-based brochures on pediatric overweight/obesity on two occasions during the 6 weeks that NOURISH-T+ families participate in the study. Check-ins will take place at 2-, 4-, 8-, and 10- months post-intervention.
Behavioral: Brief NOURISH-T+
Enhanced Usual Care (or Brief NOURISH-T+) is an abbreviated version of the full NOURISH-T+ intervention in which parents are engaged in a one-time information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Child BMI z-score
Time Frame: baseline to 6 months
Height and weight will be measured to obtain BMI z-score for gender and age.
baseline to 6 months
Change in Child BMI z-score
Time Frame: baseline to 12 months
Height and weight will be measured to obtain BMI z-score for gender and age.
baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Child Physical Activity Behaviors
Time Frame: baseline to 6 months
Waist-worn accelerometers will be worn for one week to calculate average daily step count over one week. Accelerometers objectively measure daily PA, including average steps per day, time spent in moderate-vigorous activity, and sedentary time.
baseline to 6 months
Change in Child Physical Activity Behaviors
Time Frame: baseline to 12 months
Waist-worn accelerometers will be worn for one week to calculate average daily step count over one week. Accelerometers objectively measure daily PA, including average steps per day, time spent in moderate-vigorous activity, and sedentary time.
baseline to 12 months
Change in Child Eating Behaviors
Time Frame: baseline to 6 months
Dietary Recall Automated Self-administered 24-Hour Dietary Recall-2020(ASA24). ASA24 is a highly reliable, computer assisted 24-hour dietary recall interview with animated guides and audio and visual cues to instruct participants and enhance use in low-literacy populations.
baseline to 6 months
Change in Child Eating Behaviors
Time Frame: baseline to 12 months
Dietary Recall Automated Self-administered 24-Hour Dietary Recall-2020(ASA24). ASA24 is a highly reliable, computer assisted 24-hour dietary recall interview with animated guides and audio and visual cues to instruct participants and enhance use in low-literacy populations.
baseline to 12 months
Change in Parent BMI
Time Frame: baseline to 6 months
Height and weight will be measured and used to calculate continuous adult BMI score.
baseline to 6 months
Change in Parent BMI
Time Frame: baseline to 12 months
Height and weight will be measured and used to calculate continuous adult BMI score.
baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Marilyn Stern, PhD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 30, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY000244
  • R01CA240319 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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