NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

NCT04656496 | Active Not Recruiting

• 2 other identifiers: STUDY000244R01CA240319
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 10

Brief Summary

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

Obesity, Childhood; Cancer; Survivorship

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Change in Child Physical Activity Behaviors

  baseline to 6 months

• Change in Child Physical Activity Behaviors

  baseline to 12 months

• Change in Child Eating Behaviors

  baseline to 6 months

• Change in Child Eating Behaviors

  baseline to 12 months

• Change in Parent BMI

  baseline to 6 months

Study Arms (2)

NOURISH-T+

EXPERIMENTAL

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).

Behavioral: NOURISH-T+

EUC - Brief NOURISH-T+

ACTIVE COMPARATOR

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.

Behavioral: Brief NOURISH-T+

Interventions

NOURISH-T+ BEHAVIORAL

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.

NOURISH-T+

Brief NOURISH-T+ BEHAVIORAL

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.

EUC - Brief NOURISH-T+

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Eligible Pediatric Cancer Survivors must be:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida Health System

Gainesville, Florida, 32611, United States

Location

University of Miami Health System

Miami, Florida, 33136, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

USF Pediatrics

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (50)

• 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.

  PMID: 24577544 BACKGROUND

• 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.

  PMID: 26284383 BACKGROUND

• 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.

  PMID: 19255308 BACKGROUND

• 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.

  PMID: 17182834 BACKGROUND

• 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.

  PMID: 8968860 BACKGROUND

• Greving DM, Santacroce SJ. Cardiovascular late effects. J Pediatr Oncol Nurs. 2005 Jan-Feb;22(1):38-47. doi: 10.1177/1043454204272531.

  PMID: 15574725 BACKGROUND

• 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.

  PMID: 12663727 BACKGROUND

• 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.

  PMID: 17896787 BACKGROUND

• 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.

  PMID: 11044803 BACKGROUND

• 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.

  PMID: 18064643 BACKGROUND

• 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.

  PMID: 19224548 BACKGROUND

• 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.

  PMID: 24482072 BACKGROUND

• 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.

  PMID: 19117349 BACKGROUND

• 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.

  PMID: 17459696 BACKGROUND

• 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.

  PMID: 24002505 BACKGROUND

• 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.

  PMID: 17035650 BACKGROUND

• 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.

  PMID: 14506117 BACKGROUND

• 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.

  PMID: 17644535 BACKGROUND

• Green D, Wallace H. Late effects of Childhood Cancer. CRC Press; 2003.

  BACKGROUND

• 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.

  PMID: 15654361 BACKGROUND

• 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. Erratum In: Circulation. 2013 Nov 5;128(19):e394.

  PMID: 24081971 BACKGROUND

• 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.

  PMID: 25564774 BACKGROUND

• 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.

  PMID: 10918229 BACKGROUND

• 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.

  PMID: 28130395 BACKGROUND

• 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.

  PMID: 22253364 BACKGROUND

• 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.

  PMID: 26374183 BACKGROUND

• 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.

  PMID: 19826351 BACKGROUND

• 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.

  PMID: 15526028 BACKGROUND

• 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.

  PMID: 9585006 BACKGROUND

• 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.

  PMID: 22273843 BACKGROUND

• 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.

  PMID: 22675239 BACKGROUND

• 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.

  PMID: 28959085 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25559916 BACKGROUND

• 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.

  PMID: 22735041 BACKGROUND

• 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.

  PMID: 27064243 BACKGROUND

• 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.

  PMID: 7805631 BACKGROUND

• 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.

  PMID: 2232019 BACKGROUND

• 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.

  PMID: 7287977 BACKGROUND

• 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.

  PMID: 3106445 BACKGROUND

• 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.

  PMID: 14995056 BACKGROUND

• 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.

  PMID: 17907317 BACKGROUND

• 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.

  PMID: 20063940 BACKGROUND

• 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.

  PMID: 29334983 BACKGROUND

• 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.

  PMID: 29350459 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 38668797 DERIVED

• 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.

  PMID: 36327379 DERIVED

• 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.

  PMID: 33515782 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Neoplasms

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marilyn Stern, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 7, 2020
• Study Start: December 8, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)