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Universität von SüdfloridaNOURISH-T+: Promoting Healthy Eating and Exercise Behaviors
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT04656496 (NOURISH-T+) ist eine interventionsstudie zur Untersuchung von Adipositas im Kindesalter, KREBS, Überlebenszeit und hat den Status offene rekrutierung. Die Studie startete am 8. Dezember 2020 und soll 520 Teilnehmer aufnehmen. Durchgeführt von Universität von Südflorida ist der Abschluss für 30. November 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 11. Dezember 2024 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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 at least 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.
Offizieller Titel
NOURISH-T+: A Randomized Control Trial Targeting Parents in Promoting Healthy Eating and Exercise Behaviors in Pediatric Cancer Survivors With Overweight/Obesity
Erkrankungen
Adipositas im KindesalterKREBSÜberlebenszeitPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:- Ruble K, Davis CL, Han HR. Endothelial health in childhood acute lymphoid leukemia survivors: pilot evaluation with peripheral artery tonometry. J Pediatr Hematol Oncol. 2015 Mar;37(2):117-20. doi: 10.1097/MPH.0000000000000122.
- Ruble K, Scarvalone S, Gallicchio L, Davis C, Wells D. Group Physical Activity Intervention for Childhood Cancer Survivors: A Pilot Study. J Phys Act Health. 2016 Mar;13(3):352-9. doi: 10.1123/jpah.2015-0050. Epub 2015 Aug 13.
- Nathan PC, Ford JS, Henderson TO, Hudson MM, Emmons KM, Casillas JN, Lown EA, Ness KK, Oeffinger KC. Health behaviors, medical care, and interventions to promote healthy living in the Childhood Cancer Survivor Study cohort. J Clin Oncol. 2009 May 10;27(14):2363-73. doi: 10.1200/JCO.2008.21.1441. Epub 2009 Mar 2.
- Stull VB, Snyder DC, Demark-Wahnefried W. Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. J Nutr. 2007 Jan;137(1 Suppl):243S-248S. doi: 10.1093/jn/137.1.243S.
- Reilly JJ, Blacklock CJ, Dale E, Donaldson M, Gibson BE. Resting metabolic rate and obesity in childhood acute lymphoblastic leukaemia. Int J Obes Relat Metab Disord. 1996 Dec;20(12):1130-2.
- Greving DM, Santacroce SJ. Cardiovascular late effects. J Pediatr Oncol Nurs. 2005 Jan-Feb;22(1):38-47. doi: 10.1177/1043454204272531.
- Oeffinger KC, Mertens AC, Sklar CA, Yasui Y, Fears T, Stovall M, Vik TA, Inskip PD, Robison LL; Childhood Cancer Survivor Study. Obesity in adult survivors of childhood acute lymphoblastic leukemia: a report from the Childhood Cancer Survivor Study. J Clin Oncol. 2003 Apr 1;21(7):1359-65. doi: 10.1200/JCO.2003.06.131.
- Chow EJ, Pihoker C, Hunt K, Wilkinson K, Friedman DL. Obesity and hypertension among children after treatment for acute lymphoblastic leukemia. Cancer. 2007 Nov 15;110(10):2313-20. doi: 10.1002/cncr.23050.
- Mayer EI, Reuter M, Dopfer RE, Ranke MB. Energy expenditure, energy intake and prevalence of obesity after therapy for acute lymphoblastic leukemia during childhood. Horm Res. 2000;53(4):193-9. doi: 10.1159/000023566.
- Warner JT. Body composition, exercise and energy expenditure in survivors of acute lymphoblastic leukaemia. Pediatr Blood Cancer. 2008 Feb;50(2 Suppl):456-61; discussion 468. doi: 10.1002/pbc.21411.
- Ness KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209.
- Zhang FF, Rodday AM, Kelly MJ, Must A, MacPherson C, Roberts SB, Saltzman E, Parsons SK. Predictors of being overweight or obese in survivors of pediatric acute lymphoblastic leukemia (ALL). Pediatr Blood Cancer. 2014 Jul;61(7):1263-9. doi: 10.1002/pbc.24960. Epub 2014 Jan 30.
- Cox CL, Montgomery M, Oeffinger KC, Leisenring W, Zeltzer L, Whitton JA, Mertens AC, Hudson MM, Robison LL. Promoting physical activity in childhood cancer survivors: results from the Childhood Cancer Survivor Study. Cancer. 2009 Feb 1;115(3):642-54. doi: 10.1002/cncr.24043.
- Clarke SA, Eiser C. Health behaviours in childhood cancer survivors: a systematic review. Eur J Cancer. 2007 Jun;43(9):1373-84. doi: 10.1016/j.ejca.2007.03.002. Epub 2007 Apr 24.
- Armstrong GT, Oeffinger KC, Chen Y, Kawashima T, Yasui Y, Leisenring W, Stovall M, Chow EJ, Sklar CA, Mulrooney DA, Mertens AC, Border W, Durand JB, Robison LL, Meacham LR. Modifiable risk factors and major cardiac events among adult survivors of childhood cancer. J Clin Oncol. 2013 Oct 10;31(29):3673-80. doi: 10.1200/JCO.2013.49.3205. Epub 2013 Sep 3.
- Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82. doi: 10.1056/NEJMsa060185.
- Hudson MM, Mertens AC, Yasui Y, Hobbie W, Chen H, Gurney JG, Yeazel M, Recklitis CJ, Marina N, Robison LR, Oeffinger KC; Childhood Cancer Survivor Study Investigators. Health status of adult long-term survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. JAMA. 2003 Sep 24;290(12):1583-92. doi: 10.1001/jama.290.12.1583.
- Eiser C. Beyond survival: quality of life and follow-up after childhood cancer. J Pediatr Psychol. 2007 Oct;32(9):1140-50. doi: 10.1093/jpepsy/jsm052. Epub 2007 Jul 20.
- Green D, Wallace H. Late effects of Childhood Cancer. CRC Press; 2003.
- Smith AW, Baum A, Wing RR. Stress and weight gain in parents of cancer patients. Int J Obes (Lond). 2005 Feb;29(2):244-50. doi: 10.1038/sj.ijo.0802835.
- 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 D...
Weitere Studien-IDs
- NOURISH-T+
- STUDY000244
- R01CA240319 (Zuwendung/Vertrag der US-NIH)
NCT-Nummer
Studienbeginn (tatsächlich)
2020-12-08
Zuletzt aktualisiert
2024-12-11
Studienende (vorauss.)
2025-11-30
Geplante Rekrutierung
520
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellNOURISH-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). | 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. |
Aktives VergleichspräparatEUC - 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. | 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. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in Child BMI z-score | Height and weight will be measured to obtain BMI z-score for gender and age. | baseline to 6 months |
Change in Child BMI z-score | Height and weight will be measured to obtain BMI z-score for gender and age. | baseline to 12 months |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in Child Physical Activity Behaviors | 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. | baseline to 6 months |
Change in Child Physical Activity Behaviors | 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. | baseline to 12 months |
Change in Child Eating Behaviors | 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. | baseline to 6 months |
Change in Child Eating Behaviors | 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. | baseline to 12 months |
Change in Parent BMI | Height and weight will be measured and used to calculate continuous adult BMI score. | baseline to 6 months |
Change in Parent BMI | Height and weight will be measured and used to calculate continuous adult BMI score. | baseline to 12 months |
Eignungskriterien
Zugelassene Altersgruppen
Kind
Mindestalter
5 Years
Zugelassene Geschlechter
Alle
Eligible Pediatric Cancer Survivors must be:
- 5-14 years of age at enrollment;
- Off active treatment for at least 6 months;
- At or above the 85th BMI %ile;
- Able to complete assessments with the help of clinic staff and the USF research team;
- Residing with the participating parent;
- Able to engage in PA tailored to current medical status;
- NOT taking medications that affect body weight (e.g., steroids) within 6 months of enrollment, and
- In remission -- PCS who experience a relapse of cancer during the intervention will be excused from further involvement.
- 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
- 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.
Universität von Südflorida103 aktive klinische Studien zum ErkundenNationales Krebsinstitut, USA3028 aktive klinische Studien zum ErkundenZentrale Studienkontakte
Kontakt: Marilyn Stern, PhD, 813-974-0966, [email protected]
Kontakt: Flandra Ismajli, BSW, 813-974-6135, [email protected]
10 Studienstandorte in 1 Ländern
District of Columbia
Children's National Hospital, Washington D.C., District of Columbia, 20010, United States
Catriona Mowbray, PhD, Kontakt, [email protected]
Joanna Nicole Courtis, Kontakt, [email protected]
Catriona Mowbray, PhD, Hauptprüfer
Offene Rekrutierung
Florida
University of Florida Health System, Gainesville, Florida, 32611, United States
Tung T Wynn, MD, Kontakt, 352-273-9120, [email protected]
Giselle J Moore-Higgs, Kontakt, [email protected]
Offene Rekrutierung
University of Miami Health System, Miami, Florida, 33136, United States
Jennifer Coto, PhD, Kontakt, [email protected]
Valerie Yunis, Kontakt, [email protected]
Offene Rekrutierung
Nicklaus Children's Hospital, Miami, Florida, 33155, United States
Ausgesetzt
USF Pediatrics, Tampa, Florida, 33612, United States
Ausgesetzt
Georgia
Emory University, Atlanta, Georgia, 30322, United States
Jordan Marchak, PhD, Kontakt, 404-727-2293, [email protected]
Ebonee Harris, Kontakt, [email protected]
Offene Rekrutierung
Maryland
Johns Hopkins Medicine, Baltimore, Maryland, 21287, United States
Kathy Ruble, PhD, Kontakt, 410-502-2092, [email protected]
Destiny Walker, Kontakt, [email protected]
Kathy Ruble, PhD, Hauptprüfer
Offene Rekrutierung
Missouri
Washington University School of Medicine, St Louis, Missouri, 63110, United States
Shalini Shenoy, MD, Kontakt, [email protected]
Kara Felts, Kontakt, 314-286-1177, [email protected]
Offene Rekrutierung
New Jersey
Hackensack Meridian Health, Hackensack, New Jersey, 07601, United States
Katharine R Lange, MD, Kontakt, 201-487-8987, [email protected]
Alexis Dompor, Kontakt, 551-996-4781, [email protected]
Offene Rekrutierung
Virginia
Virginia Commonwealth University, Richmond, Virginia, 23298, United States
Ausgesetzt