Recruiting

Optimal Defaults

Sponsor:

Roswell Park Cancer Institute

Code:

NCT07901816

Conditions

Pediatric

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Dietary Intervention - meal recipes

Informational Intervention

Educational Intervention

Dietary Intervention - prefilled grocery cart

Study Details

Brief summary:

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.

Conditions

Pediatric

Study ID

NCT07901816

Start date

Nov 2, 2026

Status verified date

Nov, 2026

Completion date

Nov 2, 2029

Anticipated

Primary completion date

Nov 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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

Interventions

Dietary Intervention - meal recipes

Receive main meal recipes

Informational Intervention

Meet with study staff to address any grocery shopping questions

Educational Intervention

Receive nutrition education tips

Dietary Intervention - prefilled grocery cart

Receive prefilled online grocery cart

Primary outcome measure

  • Retention Rate [ Time Frame: At 4 weeks ]
  • Percentage of Interested families Eligible for study [ Time Frame: At 4 weeks ]
  • Percentage of eligible families enrolling in study [ Time Frame: At week 4 ]
  • Percent of enrolled families completing baseline measures and proceeding to randomization [ Time Frame: At 4 weeks ]
  • Percentage of randomized families completing the study [ Time Frame: At 4 weeks ]
  • Participant reported interest in continuing to engage in program over a longer period of time. [ Time Frame: At 4 weeks ]

Central Contacts and Locations

Central contacts

ASK ROSWELLPARK

800-767-9355ASKROSWELL@Roswellpark.org

Locations

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14203

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.