NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors
NCT ID: NCT04656496
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
520 participants
INTERVENTIONAL
2020-12-08
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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.
5 Years
14 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of South Florida
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marilyn Stern, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's National Hospital
Washington D.C., District of Columbia, United States
University of Florida Health System
Gainesville, Florida, United States
University of Miami Health System
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
USF Pediatrics
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack Meridian Health
Hackensack, New Jersey, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Catriona Mowbray, PhD
Role: primary
Joanna Nicole Courtis
Role: backup
Tung T Wynn, MD
Role: primary
Giselle J Moore-Higgs
Role: backup
Jennifer Coto, PhD
Role: primary
Valerie Yunis
Role: backup
Jordan Marchak, PhD
Role: primary
Ebonee Harris
Role: backup
Kathy Ruble, PhD
Role: primary
Destiny Walker
Role: backup
Shalini Shenoy, MD
Role: primary
Kara Felts
Role: backup
Katharine R Lange, MD
Role: primary
Alexis Dompor
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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 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. No abstract available.
Stolley MR, Sharp LK, Tangney CC, Schiffer LA, Arroyo C, Kim Y, Campbell RT, Schmidt ML, Breen K, Kinahan KE, Dilley KJ, Henderson TO, Korenblit AD, Seligman K. Health behaviors of minority childhood cancer survivors. Cancer. 2015 May 15;121(10):1671-80. doi: 10.1002/cncr.29202. Epub 2015 Jan 6.
Sklar CA, Mertens AC, Walter A, Mitchell D, Nesbit ME, O'Leary M, Hutchinson R, Meadows AT, Robison LL. Changes in body mass index and prevalence of overweight in survivors of childhood acute lymphoblastic leukemia: role of cranial irradiation. Med Pediatr Oncol. 2000 Aug;35(2):91-5. doi: 10.1002/1096-911x(200008)35:23.0.co;2-g.
Stern M, Bachar E, Ronen Ackerman E, Rancourt D, Bonne O, Weintraub M. Weight Trajectories of Israeli Pediatric Cancer Survivors. J Pediatr Psychol. 2017 Jun 1;42(5):588-597. doi: 10.1093/jpepsy/jsw102.
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012 Feb 1;307(5):483-90. doi: 10.1001/jama.2012.40. Epub 2012 Jan 17.
Zhang FF, Parsons SK. Obesity in Childhood Cancer Survivors: Call for Early Weight Management. Adv Nutr. 2015 Sep 15;6(5):611-9. doi: 10.3945/an.115.008946. Print 2015 Sep.
Moyer A, Knapp-Oliver SK, Sohl SJ, Schnieder S, Floyd AH. Lessons to be learned from 25 years of research investigating psychosocial interventions for cancer patients. Cancer J. 2009 Sep-Oct;15(5):345-51. doi: 10.1097/PPO.0b013e3181bf51fb.
van Brussel M, Takken T, Lucia A, van der Net J, Helders PJ. Is physical fitness decreased in survivors of childhood leukemia? A systematic review. Leukemia. 2005 Jan;19(1):13-7. doi: 10.1038/sj.leu.2403547.
Warner JT, Bell W, Webb DK, Gregory JW. Daily energy expenditure and physical activity in survivors of childhood malignancy. Pediatr Res. 1998 May;43(5):607-13. doi: 10.1203/00006450-199805000-00008.
Mazzeo SE, Kelly NR, Stern M, Gow RW, Serdar K, Evans RK, Jones RM, Bulik CM. Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH): design and methods. Contemp Clin Trials. 2012 May;33(3):515-22. doi: 10.1016/j.cct.2012.01.003. Epub 2012 Jan 18.
Mackinnon DP. Integrating Mediators and Moderators in Research Design. Res Soc Work Pract. 2011 Nov;21(6):675-681. doi: 10.1177/1049731511414148. Epub 2011 Jul 13.
Lydecker JA, Simpson C, Kwitowski M, Gow RW, Stern M, Bulik CM, Mazzeo SE. Evaluation of Parent-Reported Feeding Practices in a Racially Diverse, Treatment-Seeking Child Overweight/Obesity Sample. Child Health Care. 2017;46(3):265-281. doi: 10.1080/02739615.2016.1163489. Epub 2016 Mar 17.
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, Ewing L, Davila E, Thompson AL, Hale G, Mazzeo S. Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment. Contemp Clin Trials. 2015 Mar;41:227-37. doi: 10.1016/j.cct.2014.12.018. Epub 2015 Jan 2.
Bean MK, Wilson DB, Thornton LM, Kelly N, Mazzeo SE. Dietary intake in a randomized-controlled pilot of NOURISH: a parent intervention for overweight children. Prev Med. 2012 Sep;55(3):224-7. doi: 10.1016/j.ypmed.2012.06.016. Epub 2012 Jun 24.
Raber M, Swartz MC, Santa Maria D, O'Connor T, Baranowski T, Li R, Chandra J. Parental involvement in exercise and diet interventions for childhood cancer survivors: a systematic review. Pediatr Res. 2016 Sep;80(3):338-46. doi: 10.1038/pr.2016.84. Epub 2016 Apr 11.
Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year outcomes of behavioral family-based treatment for childhood obesity. Health Psychol. 1994 Sep;13(5):373-83. doi: 10.1037//0278-6133.13.5.373.
Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year follow-up of behavioral, family-based treatment for obese children. JAMA. 1990 Nov 21;264(19):2519-23.
Epstein LH, Wing RR, Koeske R, Andrasik F, Ossip DJ. Child and parent weight loss in family-based behavior modification programs. J Consult Clin Psychol. 1981 Oct;49(5):674-85. doi: 10.1037//0022-006x.49.5.674. No abstract available.
Epstein LH, Wing RR, Koeske R, Valoski A. Long-term effects of family-based treatment of childhood obesity. J Consult Clin Psychol. 1987 Feb;55(1):91-5. doi: 10.1037//0022-006x.55.1.91. No abstract available.
Golan M, Crow S. Parents are key players in the prevention and treatment of weight-related problems. Nutr Rev. 2004 Jan;62(1):39-50. doi: 10.1111/j.1753-4887.2004.tb00005.x.
Golan M. Parents as agents of change in childhood obesity--from research to practice. Int J Pediatr Obes. 2006;1(2):66-76. doi: 10.1080/17477160600644272.
Kitzmann KM, Dalton WT 3rd, Stanley CM, Beech BM, Reeves TP, Buscemi J, Egli CJ, Gamble HL, Midgett EL. Lifestyle interventions for youth who are overweight: a meta-analytic review. Health Psychol. 2010 Jan;29(1):91-101. doi: 10.1037/a0017437.
Smith JD, Berkel C, Jordan N, Atkins DC, Narayanan SS, Gallo C, Grimm KJ, Dishion TJ, Mauricio AM, Rudo-Stern J, Meachum MK, Winslow E, Bruening MM. An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study). Implement Sci. 2018 Jan 15;13(1):11. doi: 10.1186/s13012-017-0697-2.
Stern M, Bleck J, Ewing LJ, Davila E, Lynn C, Hale G, Mazzeo S. NOURISH-T: Targeting caregivers to improve health behaviors in pediatric cancer survivors with obesity. Pediatr Blood Cancer. 2018 May;65(5):e26941. doi: 10.1002/pbc.26941. Epub 2018 Jan 19.
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.
Brown 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.
Buro 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.
Stern 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY000244
Identifier Type: -
Identifier Source: org_study_id