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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04656496
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : October 12, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

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
Obesity, Childhood Cancer Survivorship Behavioral: NOURISH-T+ Behavioral: Brief NOURISH-T+ Not Applicable

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 more than 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 8, 2020
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in Parent BMI [ Time Frame: baseline to 6 months ]
    Height and weight will be measured and used to calculate continuous adult BMI score.

  6. Change in Parent BMI [ Time Frame: baseline to 12 months ]
    Height and weight will be measured and used to calculate continuous adult BMI score.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656496


Contacts
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Contact: Marilyn Stern, PhD 813-974-0966 mstern1@usf.edu
Contact: Flandra Ismajli, BSW 813-974-6135 flandraismaj@usf.edu

Locations
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United States, District of Columbia
Children's National Hospital Recruiting
Washington, District of Columbia, United States, 20010
Contact: Catriona Mowbray, PhD       CMowbray@childrensnational.org   
Contact: Cindy Gonzalez       cgonzalez@childrensnational.org   
Principal Investigator: Catriona Mowbray, PhD         
United States, Florida
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Haneen Abdella, MD    305-662-8360    Haneen.Abdella@Nicklaushealth.org   
Contact: Kristen Mendez, APRN       Kristen.Mendez@Nicklaushealth.org   
Principal Investigator: Haneen Abdella, MD         
USF Pediatrics Recruiting
Tampa, Florida, United States, 33612
Contact: Andrew Galligan, MD       agalligan@usf.edu   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jordan Marchak, PhD    404-727-2293    jgillel@emory.edu   
Contact: Ebonee Harris       ebonee.harris@choa.org   
United States, Maryland
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kathy Ruble, PhD    410-502-2092    rubleka@jhmi.edu   
Contact: Destiny Walker       dwalke64@jhmi.edu   
Principal Investigator: Kathy Ruble, PhD         
United States, Virginia
Virginia Commonwealth University Suspended
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
University of South Florida
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Marilyn Stern, PhD University of South Florida
Publications:
Green D, Wallace H. Late effects of Childhood Cancer. CRC Press; 2003.
Lipshultz SE, Adams MJ, Colan SD, Constine LS, Herman EH, Hsu DT, Hudson MM, Kremer LC, Landy DC, Miller TL, Oeffinger KC, Rosenthal DN, Sable CA, Sallan SE, Singh GK, Steinberger J, Cochran TR, Wilkinson JD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Basic Cardiovascular Sciences, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Radiolo. Long-term cardiovascular toxicity in children, adolescents, and young adults who receive cancer therapy: pathophysiology, course, monitoring, management, prevention, and research directions: a scientific statement from the American Heart Association. Circulation. 2013 Oct 22;128(17):1927-95. doi: 10.1161/CIR.0b013e3182a88099. Epub 2013 Sep 30. Erratum in: Circulation. 2013 Nov 5;128(19):e394.
Stern, M., Mazzeo, S.E., Porter, J. et al. Self-Esteem, Teasing and Quality of Life: African American Adolescent Girls Participating in a Family-Based Pediatric Overweight Intervention. J Clin Psychol Med Settings 13, 217 (2006). https://doi.org/10.1007/s10880-006-9029-4
Stern, M., Lamanna, J., Russell, C., Ewing, L., Thompson, A., Trapp, S., Bitsko, M., & Mazzeo, S. (2013). Adaptation of an obesity intervention program for pediatric cancer survivors (NOURISH-T). Clinical Practice in Pediatric Psychology, 1(3), 264-275. https://doi.org/10.1037/cpp0000023
Mazzeo S, Gow R, Stern M, Gerke C. Developing an intervention for parents of overweight children. International Journal of Child and Adolescent Health. 2008;1(4):355-363.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT04656496    
Other Study ID Numbers: STUDY000244
R01CA240319 ( U.S. NIH Grant/Contract )
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight