NOURISH-T+ Weight Management for Childhood Cancer Survivors

(NOURISH-T+ Trial)

Recruiting at 8 trial locations

Overseen By Flandra Ismajli, BSW

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must not be taking: Steroids

Disqualifiers: Non-ambulatory, Pregnant, Wards of state

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

520 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help parents of childhood cancer survivors learn skills to prevent and reduce obesity in their children. The study includes two groups: one receives detailed training and support on healthy eating and exercise through the NOURISH-T+ program, while the other attends a brief session with general information. It suits families with children who have survived cancer, are no longer in active treatment, and face weight concerns (at or above the 85th BMI percentile). Parents play a crucial role by learning to model healthy habits positively. As an unphased trial, this study offers families a unique opportunity to gain valuable skills and support for promoting healthier lifestyles.

Will I have to stop taking my current medications?

Participants must not be taking medications that affect body weight, like steroids, within 6 months of joining the study.

What prior data suggests that the NOURISH-T+ program is safe for childhood cancer survivors?

Research shows that NOURISH-T+ is a program designed to help parents improve their child's health and has proven safe in past studies. This program teaches parents how to encourage healthy eating and physical activity in children who have survived cancer. Similar programs, like NOURISH-T, have demonstrated that parents noticed positive changes, such as lower body weight and healthier family eating habits. These benefits suggest that the program is generally well-received, with no major safety issues reported. Although not a medication or physical treatment, earlier versions of the program have been safe for families to join. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NOURISH-T+ because it targets parents as agents of change to improve the health of childhood cancer survivors. Unlike traditional treatments that focus solely on the child, this approach involves intensive parent skills training to encourage healthy eating and physical activity. Delivered through video conferencing, it includes personalized nutritional strategies from a pediatric oncology dietitian, making it both accessible and tailored. This unique family-centered approach could lead to sustainable lifestyle changes, which is why it's generating interest in the medical community.

What evidence suggests that this trial's treatments could be effective for weight management in childhood cancer survivors?

Research has shown that about 40-50% of children who survive cancer become overweight or obese, increasing their risk for health problems like metabolic syndrome. In this trial, the NOURISH-T+ program emphasizes the role of parents as key models for promoting healthy habits in their children. Studies have found that involving parents in health education effectively improves children's eating and exercise habits. The NOURISH-T+ program teaches parents to demonstrate positive health behaviors, helping children develop better habits. This program builds on earlier successful initiatives, suggesting it could effectively manage weight among childhood cancer survivors. Another arm of this trial, the Brief NOURISH-T+ program, involves parents in a single information session and provides additional resources, serving as an active comparator. ^{1 3 5 6 7}

Who Is on the Research Team?

Marilyn Stern, PhD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking pediatric cancer survivors aged 5-14, who are overweight (above the 85th BMI percentile), off treatment for at least 6 months, and in remission. Their parents must be adults, main meal preparers, and able to exercise according to their medical status. Pregnant women and non-ambulatory individuals cannot participate.

Inclusion Criteria

I haven't received any cancer treatment for the last 6 months.

I can complete assessments with help from clinic staff and the research team.

My cancer is currently in remission.

Exclusion Criteria

In addition, children who are wards of the state will be excluded from the study

I am not currently pregnant.

My child can walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

NOURISH-T+ group receives 6 weekly, 1-1.5 hour sessions via video-conferencing, with additional sessions for child engagement and a session with a pediatric oncology dietician.

6 weeks

6 weekly sessions (virtual), 2 additional sessions (virtual), 1 session with dietician (virtual)

Follow-up

Brief booster sessions at 2-, 4-, 8-, and 10-months post-intervention to maximize retention and follow-up participation.

10 months

4 booster sessions (virtual)

Outcome Measures

Outcome measures completed at baseline, 3-, 6-, and 12-months post-intervention to assess changes in child eating behaviors, parent BMI, and child physical activity behaviors.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Brief NOURISH-T+
• NOURISH-T+

Trial Overview The NOURISH-T+ study aims to teach parents of childhood cancer survivors how to prevent obesity through two web-based educational groups. It focuses on healthy eating and exercise behaviors with the goal of improving long-term health outcomes like reducing heart disease risk.

How Is the Trial Designed?

Group I: NOURISH-T+ Experimental Treatment 1 Intervention

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).

Group II: EUC - Brief NOURISH-T+ Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The NOURISH-T+ intervention aims to address the high rates of overweight and obesity among pediatric cancer survivors by providing a comprehensive 6-session program for parents, which includes dietary guidance and physical activity support, targeting children aged 5-12 who are at least 6 months off treatment.

This larger randomized control trial will involve 260 parent-child pairs from four pediatric oncology clinics, assessing the intervention's effectiveness on children's BMI, physical activity, and dietary behaviors over 12 months, compared to a standard care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity: Rationale and study protocol of NOURISH-T. Stern, M., Gray, HL., Ruble, K., et al.[2022]

Children undergoing cancer treatment have significantly higher fat mass and lower body cell mass compared to healthy controls, indicating a risk of overnutrition during treatment.

Both children currently in treatment and childhood cancer survivors show high rates of undernutrition, with 48% and 53% respectively, highlighting the need for nutritional support in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body composition of children with cancer during treatment and in survivorship. Murphy, AJ., White, M., Elliott, SA., et al.[2023]

This scoping review analyzed 9 studies on malnutrition in pediatric cancer treatment, revealing that various nutritional interventions, such as appetite stimulants and supplements, can lead to improved weight outcomes, although the specific methods used showed no significant differences in effectiveness.

The review highlighted a lack of standardized definitions and screening tools for malnutrition, indicating that while some screening methods may reduce malnutrition risk and improve weight gain, there is a critical need for consistent assessment and treatment strategies in pediatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malnutrition screening and treatment in pediatric oncology: a scoping review. Franke, J., Bishop, C., Runco, DV.[2022]

In a study of 221 pediatric patients with solid tumors treated with cisplatin, obesity at diagnosis was linked to a more than threefold increased risk of severe treatment-related toxicities (TRT), particularly kidney injuries.

Obesity and being an adolescent or young adult at diagnosis were associated with significantly worse event-free and overall survival rates, indicating that these groups may require closer monitoring and tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of body mass index with toxicity and survival in pediatric patients treated with cisplatin-containing regimens. Bhandari, R., Scott, E., Yeh, MY., et al.[2022]

Nutritional status at the time of cancer diagnosis significantly affects survival outcomes in children, with both under-nourished and over-nourished children experiencing worse overall survival and event-free survival rates.

Specifically, children with leukemia who had a higher body mass index at diagnosis faced a 30-50% increased risk of death and relapse, while malnourished children with osteosarcoma and Ewing sarcoma had higher treatment-related toxicity, highlighting the importance of nutritional management in pediatric cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Status at Diagnosis as Predictor of Survival from Childhood Cancer: A Review of the Literature. Karalexi, MA., Markozannes, G., Tagkas, CF., et al.[2022]

A pilot randomized controlled trial (RCT) called NOURISH-T aims to reduce overweight and obesity rates among pediatric cancer survivors (PCS) by targeting their caregivers to promote healthier eating and physical activity, focusing on children aged 5-12 who are 6 months to 4 years off active treatment.

The intervention adapts an existing program, NOURISH, which has previously been effective in reducing BMI in overweight children, and will assess its preliminary efficacy compared to Enhanced Usual Care over a 6-week period, with follow-up assessments at 4 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment. Stern, M., Ewing, L., Davila, E., et al.[2021]

Childhood cancer survivors (CCS) treated with cranial/craniospinal radiotherapy (CRT) showed a higher prevalence of overweight at final height (14%) compared to age-matched controls (4%), indicating a significant impact of CRT on long-term weight outcomes.

In contrast, CCS who received high doses of anthracyclines (> 300 mg/m²) were more likely to be underweight at final height, and they experienced a lower annual increase in BMI, suggesting that different cancer treatments have distinct effects on body weight and growth patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body mass index and annual increase of body mass index in long-term childhood cancer survivors; relationship to treatment. Brouwer, CA., Gietema, JA., Vonk, JM., et al.[2021]

Among 50 childhood cancer survivors assessed, 20% were overweight or obese, and 54% consumed more calories than recommended, indicating a need for dietary interventions.

Parents of these survivors tended to use restrictive feeding practices, which may contribute to poor dietary habits, suggesting that addressing both dietary intake and parenting styles could help mitigate long-term health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intake after treatment in child cancer survivors. Cohen, J., Wakefield, CE., Fleming, CA., et al.[2015]

Among 62 survivors of childhood acute lymphoblastic leukemia (ALL), obesity and overweight rates varied significantly by age group, with 73% of preschool children, 68% of school-age children, and 47% of adolescents being classified as obese or overweight at some point after diagnosis.

Preschool children showed the fastest increase in obesity rates immediately following therapy, highlighting the need for targeted obesity prevention efforts in this age group before treatment completion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of Obesity and Overweight Rates Among Survivors of Childhood Acute Lymphoblastic Leukemia. Winkler, MR., Hockenberry, MJ., McCarthy, KS., et al.[2017]

Nutritional status during cancer treatment significantly affects treatment-related toxicities and outcomes in children and adolescents, with lasting impacts into survivorship.

Many childhood cancer survivors do not meet recommended dietary guidelines, which may lead to negative nutrition-related health outcomes, highlighting the need for further research to inform clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Counseling in Survivors of Childhood Cancer: An Essential Component of Survivorship Care. Ladas, EJ.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8009853/

Rationale and Study Protocol of NOURISH-T+ - PMC Approximately 40–50% of pediatric cancer survivors (PCS) are overweight or obese; increasing their risk for metabolic syndrome and other negative long-term ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33515782/

A cluster-randomized control trial targeting parents ... A cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity: Rationale and study protocol of NOURISH-T. Contemp Clin Trials ...

3. nourisht-study.com nourisht-study.com/

Home | NOURISH-T+ NOURISH-T+ is a research intervention program to teach parents about healthy habits for pediatric cancer survivors to reduce obesity and prevent future diseases ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-01661

Promoting Healthy Eating and Exercise Behaviors - NCI 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 ...

5. researchgate.net researchgate.net/publication/348824958_A_cluster-randomized_control_trial_targeting_parents_of_pediatric_cancer_survivors_with_obesity_Rationale_and_study_protocol_of_NOURISH-T

Rationale and study protocol of NOURISH-T+ | Request PDF A cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity: Rationale and study protocol of NOURISH-T+ | ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442100032X

Rationale and study protocol of NOURISH-T+ NOURISH-T parents also showed significant decreases in BMI, WHR, and daily caloric intake, and significant changes in family eating practices [27]. Based on ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8077729/

Design and Rationale for NOURISH-T Five years post-treatment, 21% of all survivors are classified as obese (BMI ≥95thpercentile ([%ile]) for age and gender) and 20% as overweight (BMI>85th%ile ...