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ReclutandoNCT07901816Registro de ClinicalTrials.gov

Optimal Defaults Grocery Shopping Intervention to Promote Healthy Diets for Pediatric Cancer Survivors and Their Families

Pediatric

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
2 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
160 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This clinical trial tests the feasibility, acceptability and effect of an optimal defaults grocery shopping intervention to promote healthy diets for pediatric cancer survivors and their families. Pediatric cancer survivors are a growing population who are at an increased risk of developing chronic conditions and treatment-related complications. Poor nutritional intake can significantly worsen chronic health conditions experienced by survivors. Children who have poorer nutrition post-treatment are at greater risk for cancer recurrence. Interventions that effectively support families in obtaining and consuming healthier food and improve dietary intake are poised to improve developmental outcomes among pediatric cancer survivors. One promising way to impact the family diet is by targeting food purchasing. Optimal defaults, or making the healthy choice the automatic choice, is a specific nudge strategy that may be a feasible, acceptable and effective way to promote healthier food purchasing and dietary intake among pediatric cancer survivors and their families.

Leer la descripción completa

PRIMARY OBJECTIVES:

I. To test the feasibility and acceptability of an optimal defaults grocery shopping intervention among families with a survivor of pediatric cancer.

II. To test effects of the defaults intervention on the nutritional quality, energy content, and cost of household grocery purchases and children's usual dietary intake, including nutritional quality and energy intake, as well as intake of fat, carbohydrates, protein, and added sugar.

IIa. Examine effects of the intervention on dietary intake of the enrolled parent/guardian

OUTLINE:

Families (cancer survivor and their parent/legal guardian) shop for groceries as normal for 2 weeks, using Instacart for at least 75% of shopping, and provide receipts for this shopping. At the end of Week 2, families meet with study staff to address any grocery shopping questions. Families are then randomized to 1 of 2 groups.

GROUP 1: Families receive 4 recipes per week for 2 weeks while continuing to record their grocery shopping. Recipe packets include 3 main meal recipes as well as an idea of an additional breakfast/lunch/snack that can be made with leftovers from the main meal recipes, nutritional characteristics of the recipes and some simple nutrition education tips. Recipes options can be assigned depending on families' dietary restrictions and food preferences. At the end of Week 4, families meet with study staff to address any grocery shopping questions.

GROUP 2: Families receive 4 recipes per week for 2 weeks, continue to record their grocery shopping, and have their online Instacart grocery carts prefilled with the ingredients needed to make the recipes. Families may make changes to their carts as they like. Recipe packets include 3 main meal recipes as well as an idea of an additional breakfast/lunch/snack that can be made with leftovers from the main meal recipes, nutritional characteristics of the recipes and some simple nutrition education tips. Recipes options can be assigned depending on families' dietary restrictions and food preferences. At the end of Week 4, families meet with study staff to address any grocery shopping questions.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

  • Parent (or legal guardian) of child that is a survivor of pediatric cancer (any diagnosis)
  • Pediatric patient age: 2 ≤ age \< 17 years old at time of study entry
  • Child receiving follow-up care at the Roswell Park Comprehensive Cancer Center. The child should no longer be receiving active cancer directed therapy at time of enrollment. There is no limit to the time post treatment
  • Parent is the primary caregiver of the child. This is defined as being the parent/guardian who is the most aware of the child's daily activities (or one of multiple guardians who are equally aware)
  • Parent does at least 50% of the grocery shopping for the family
  • Can be current online grocery shopper or willing to online grocery shop during the study, meeting these requirements: ≥ 75% of their grocery shopping from 1 of 4 specific grocery stores via Instacart (Wegmans, Aldi, Tops, and/or Walmart)
  • Child eats ≥ 3 main meals at home with the participating parent per week
  • Family does not have any dietary restrictions that would preclude them from being able to use at least some recipes in the study's recipe bank. Most dietary restrictions and preferences (e.g., vegetarian, vegan, halal, gluten-free, allergies to or preferences to avoid particular specific foods) can be accommodated by our large and diverse recipe bank. Only more severe and extensive restrictions would render a family ineligible, such as not being able to eat foods across multiple major food groups
  • No history of eating disorders. This includes no history of eating disorders in the participating child's medical record. Parent will also be asked during the screening process to self-report whether or not they have ever been diagnosed with an eating disorder themself
  • Participant is not currently receiving supplemental nutritional support such as nasogastric tube (NG), gastrostomy tube (GT) or parenteral support
  • Participant is not actively utilizing a medically-tailored meal program, such as RxDiet
  • Parent age: \> 18 years-old - NA (No Limit)
  • Parent fluent in English
  • Participant (or legal representative) must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Parent is unwilling or unable to follow protocol requirements
  • Not meeting above inclusion criteria
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Enmascaramiento simple
Group 1 - Main Meal Recipes

Families (cancer survivor and their parent/legal guardian) shop for groceries as normal for 2 weeks, using Instacart for at least 75% of shopping, and provide receipts for this shopping. At the end of Week 2, families meet with study staff to address any grocery shopping questions. Families receive 4 recipes per week for 2 weeks while continuing to record their grocery shopping. Recipe packets include 3 main meal recipes as well as an idea of an additional breakfast/lunch/snack that can be made with leftovers from the main meal recipes, nutritional characteristics of the recipes and some simple nutrition education tips. Recipe options can be assigned depending on families' dietary restrictions and food preferences. At the end of Week 4, families meet with study staff to address any grocery shopping questions.

Other: Dietary Intervention - meal recipes · Other: Informational Intervention · Other: Educational Intervention

Group 2 - Main meal recipes, prefilled grocery cart

Families (cancer survivor and their parent/legal guardian) shop for groceries as normal for 2 weeks, using Instacart for at least 75% of shopping, and provide receipts for this shopping. At the end of Week 2, families meet with study staff to address any grocery shopping questions. Families receive 4 recipes per week for 2 weeks, continue to record their grocery shopping, and have their online Instacart grocery carts prefilled with the ingredients needed to make the recipes. Families may make changes to their carts as they like. Recipe packets include 3 main meal recipes as well as an idea of an additional breakfast/lunch/snack that can be made with leftovers from the main meal recipes, nutritional characteristics of the recipes and some simple nutrition education tips. Recipe options can be assigned depending on families' dietary restrictions and food preferences. At the end of Week 4, families meet with study staff to address any grocery shopping concerns

Other: Dietary Intervention - meal recipes · Other: Educational Intervention · Other: Dietary Intervention - prefilled grocery cart

Dietary Intervention - meal recipes OTHER

Receive main meal recipes

Informational Intervention OTHER

Meet with study staff to address any grocery shopping questions

Educational Intervention OTHER

Receive nutrition education tips

Dietary Intervention - prefilled grocery cart OTHER

Receive prefilled online grocery cart

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Retention Rate

Plazo: At 4 weeks

Percentage of study cohort who complete the study

Percentage of Interested families Eligible for study

Plazo: At 4 weeks

Feasibility defined as ≥ 50% of interested families being eligible for the study

Percentage of eligible families enrolling in study

Plazo: At week 4

Feasibility defined as ≥ 50% of eligible families enrolling

Percent of enrolled families completing baseline measures and proceeding to randomization

Plazo: At 4 weeks

Feasibility defined as ≥ 90% of enrolled families successfully completing baseline measures and proceeding to randomization

Percentage of randomized families completing the study

Plazo: At 4 weeks

Feasibility defined as ≥ 85% of randomized families completing the study.

Participant reported interest in continuing to engage in program over a longer period of time.

Plazo: At 4 weeks

As reported by participants by Phone call

Medidas secundarias

Change in household grocery purchases: nutritional quality

Plazo: From baseline to end of study - up to 4 weeks

Nutritional quality will be calculated based on quintiles for each of 13 indicators that correspond to the Healthy Eating Index: total fruit, whole fruit, total vegetables, dark green and legume vegetables, whole grains, dairy, total protein foods, seafood and plant proteins, the ratio of mono and polyunsaturated fatty acids to saturated fatty acids, refined grains, sodium, added sugars, and saturated fats. Quintile scores will be summed to generate nutritional quality of grocery purchases each week

Changes in household grocery purchases: energy content

Plazo: UP to 4 weeks

Total energy content of groceries purchased for the household each week

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Roswell Park Comprehensive Cancer CenterBuffalo, New York, United StatesReclutando

Equipo y fechas

Patrocinador principal
Roswell Park Cancer Institute
Inicio del estudio
2 nov 2026 Estimado
Finalización primaria
2 nov 2028 Estimado
Finalización del estudio
2 nov 2029 Estimado
Primera publicación
28 oct 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Título oficial del estudio

Using an Optimal Defaults Grocery Shopping Intervention to Promote Healthy Diets in the Context of Pediatric Cancer Survivorship

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026