NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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).
interventionNames
Behavioral: NOURISH-T+
type
ACTIVE_COMPARATOR
label
EUC - Brief NOURISH-T+
description
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.
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
5 Years
Maximum age
14 Years
Show eligibility criteria text
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.
References
Publications (50)
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interventionNames
Behavioral: Brief NOURISH-T+
Primary outcomes (2)
measure
Change in Child BMI z-score
timeFrame
baseline to 6 months
description
Height and weight will be measured to obtain BMI z-score for gender and age.
measure
Change in Child BMI z-score
timeFrame
baseline to 12 months
description
Height and weight will be measured to obtain BMI z-score for gender and age.
Secondary outcomes (6)
measure
Change in Child Physical Activity Behaviors
timeFrame
baseline to 6 months
description
Waist-worn accelerometers, wrist-worn accelerometers, or fitness trackers will be worn for at least 4 days to calculate average daily step count.
measure
Change in Child Physical Activity Behaviors
timeFrame
baseline to 12 months
description
Waist-worn accelerometers, wrist-worn accelerometers, or fitness trackers will be worn for at least 4 days to calculate average daily step count.
measure
Change in Child Eating Behaviors
timeFrame
baseline to 6 months
description
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.
measure
Change in Child Eating Behaviors
timeFrame
baseline to 12 months
description
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.
measure
Change in Parent BMI
timeFrame
baseline to 6 months
description
Height and weight will be measured and used to calculate continuous adult BMI score.
measure
Change in Parent BMI
timeFrame
baseline to 12 months
description
Height and weight will be measured and used to calculate continuous adult BMI score.
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DERIVEDBrown NI, Sauls R, Almendares M, Gray HL, Stern M. Factors impacting physical activity among post-treatment pediatric cancer survivors with overweight and obesity. Eur J Pediatr. 2024 Jul;183(7):3129-3136. doi: 10.1007/s00431-024-05584-6. Epub 2024 Apr 26. PMID 38668797
DERIVEDBuro AW, Gray HL, Ruble K, Soca Lozano S, Sauls R, Albizu-Jacob A, Crowder SL, Mazzeo SE, Stern M. Challenges and adaptations for a cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity during the COVID-19 pandemic. Transl Behav Med. 2023 Feb 28;13(2):98-103. doi: 10.1093/tbm/ibac084. PMID 36327379
DERIVEDStern M, Gray HL, Ruble K, Soca Lozano S, Albizu-Jacob A, Williams JM, Godder K, Fuemmeler B, Mazzeo S. A cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity: Rationale and study protocol of NOURISH-T. Contemp Clin Trials. 2021 Mar;102:106296. doi: 10.1016/j.cct.2021.106296. Epub 2021 Jan 27. PMID 33515782