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NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

Sponsor
University of South Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04656496
Collaborator
National Cancer Institute (NCI) (NIH)
520
Enrollment
6
Locations
2
Arms
55.6
Anticipated Duration (Months)
86.7
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NOURISH-T+
  • Behavioral: Brief NOURISH-T+
 N/A

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 5-12.9 years) with overweight and obesity, and off treatment for more than 6 months to up to less than 5 years will be recruited across multiple pediatric oncology clinic sites: Johns Hopkins Medical Center, Nicklaus Children's Hospital, Virginia Commonwealth University and, Children's National Hospital. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
520 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
NOURISH-T+: A Randomized Control Trial Targeting Parents in Promoting Healthy Eating and Exercise Behaviors in Pediatric Cancer Survivors With Overweight/Obesity
Actual Study Start Date :
Dec 8, 2020
Anticipated Primary Completion Date :
Jul 26, 2025
Anticipated Study Completion Date :
Jul 26, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Child BMI z-score [baseline to 6 months]

    Height and weight will be measured to obtain BMI z-score for gender and age.

  2. Change in Child BMI z-score [baseline to 12 months]

    Height and weight will be measured to obtain BMI z-score for gender and age.

Secondary Outcome Measures

  1. Change in Child Physical Activity Behaviors [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.

  2. Change in Child Physical Activity Behaviors [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.

  3. Change in Child Eating Behaviors [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.

  4. Change in Child Eating Behaviors [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.

  5. Change in Parent BMI [baseline to 6 months]

    Height and weight will be measured and used to calculate continuous adult BMI score.

  6. Change in Parent BMI [baseline to 12 months]

    Height and weight will be measured and used to calculate continuous adult BMI score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Eligible Pediatric Cancer Survivors must be:

  1. 5-12.9 years of age at enrollment;

  2. Off active treatment for at least 6 months and < 5 years;

  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 may 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's National Hospital Washington District of Columbia United States 20010
2 Nicklaus Children's Hospital Miami Florida United States 33155
3 USF Pediatrics Tampa Florida United States 33612
4 Emory University Atlanta Georgia United States 30322
5 Johns Hopkins Medicine Baltimore Maryland United States 21287
6 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • University of South Florida
  • National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of South Florida
ClinicalTrials.gov Identifier:
NCT04656496
Other Study ID Numbers:
  • STUDY000244
  • R01CA240319
First Posted:
Dec 7, 2020
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obesity
Pediatric Obesity

Study Results

No Results Posted as of Jan 25, 2022