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NOURISH-T+ Weight Management for Childhood Cancer Survivors (NOURISH-T+ Trial)

Q: How many locations have been chosen to execute this trial?

<p>Nicklaus Children's Hospital in Miami, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>, Johns Hopkins Medicine in Baltimore, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a> and USF Pediatrics in Tampa, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a> are three of the six clinical trial sites currently running this investigation.</p>

N/A

Recruiting

Led By Marilyn Stern, PhD

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Off active treatment for at least 6 months

Must be English- or Spanish-speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

NOURISH-T+ Trial Summary

This trial is studying whether a weight management intervention delivered through a smartphone app can help prevent weight gain in survivors of childhood cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medications, there are no direct side effects from drugs; however, changes in diet and physical activity might cause temporary discomfort or require adjustment periods.

NOURISH-T+ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I speak English or Spanish.

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I am between 5 and 14 years old.

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I am 18 years old or older.

NOURISH-T+ Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Child BMI z-score

Secondary outcome measures

Change in Child Eating Behaviors

Change in Child Physical Activity Behaviors

Change in Parent BMI

NOURISH-T+ Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NOURISH-T+Experimental Treatment1 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 Control1 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,666 Previous Clinical Trials

40,925,509 Total Patients Enrolled

University of South FloridaLead Sponsor

412 Previous Clinical Trials

186,539 Total Patients Enrolled

Marilyn Stern, PhDPrincipal InvestigatorUniversity of South Florida

2 Previous Clinical Trials

201 Total Patients Enrolled

Media Library

NOURISH-T+ Clinical Trial Eligibility Overview. Trial Name: NCT04656496 — N/A

Childhood Obesity Research Study Groups: NOURISH-T+, EUC - Brief NOURISH-T+

Childhood Obesity Clinical Trial 2023: NOURISH-T+ Highlights & Side Effects. Trial Name: NCT04656496 — N/A

NOURISH-T+ 2023 Treatment Timeline for Medical Study. Trial Name: NCT04656496 — N/A

Childhood Obesity Patient Testimony for trial: Trial Name: NCT04656496 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any openings for participants in this clinical trial?

"According to the data hosted on clinicaltrials.gov, this study is still actively searching for participants after being initially posted on December 8th 2020 and subsequently updated in October 7th 2022."

Answered by AI

How many locations have been chosen to execute this trial?

"Nicklaus Children's Hospital in Miami, Florida, Johns Hopkins Medicine in Baltimore, Maryland and USF Pediatrics in Tampa, Georgia are three of the six clinical trial sites currently running this investigation."

Answered by AI

Is there an age limit for enrollment in this experiment?

"The eligibility requirements for this trial are limited to individuals aged between 5 and 14. There are 315 clinical trials that involve minors and 1060 studies recruiting participants over 65 years old."

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Am I eligible to be a volunteer in this medical research?

"This study seeks participants aged 5-14 with malignancies to join its ranks, currently standing at 520 enrollees."

Answered by AI

What is the upper limit of patient enrolment in this clinical trial?

"To successfully conduct this medical trial, 520 qualified participants must enroll. These individuals can apply for the study at a variety of sites, namely Nicklaus Children's Hospital in Miami and Johns Hopkins Medicine in Baltimore."

Answered by AI