PediatricNCT07901816
Optimal Defaults Grocery Shopping Intervention to Promote Healthy Diets for Pediatric Cancer Survivors and Their Families
A study testing Dietary Intervention - meal recipes, Informational Intervention and Educational Intervention in people with Pediatric, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric
- What is being tested?
- Dietary Intervention - meal recipes, Informational Intervention and Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to 2 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- Parent is unwilling or unable to follow protocol requirements
- Not meeting above inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
About this study
Official title: Using an Optimal Defaults Grocery Shopping Intervention to Promote Healthy Diets in the Context of Pediatric Cancer Survivorship
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Pediatric
- Being tested
- Dietary Intervention - meal recipes, Informational Intervention, Educational Intervention, Dietary Intervention - prefilled grocery cart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Intervention - meal recipesOther
Receive main meal recipes
Informational InterventionOther
Meet with study staff to address any grocery shopping questions
Educational InterventionOther
Receive nutrition education tips
Dietary Intervention - prefilled grocery cartOther
Receive prefilled online grocery cart
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Main Meal Recipes | Active comparator | 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. Receives: Other: Dietary Intervention - meal recipes; Other: Informational Intervention; Other: Educational Intervention |
| Group 2 - Main meal recipes, prefilled grocery cart | Experimental | 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 Receives: Other: Dietary Intervention - meal recipes; Other: Educational Intervention; Other: Dietary Intervention - prefilled grocery cart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Percentage of study cohort who complete the study
Measured: At 4 weeks
Percentage of Interested families Eligible for study
Feasibility defined as ≥ 50% of interested families being eligible for the study
Measured: At 4 weeks
Percentage of eligible families enrolling in study
Feasibility defined as ≥ 50% of eligible families enrolling
Measured: At week 4
Percent of enrolled families completing baseline measures and proceeding to randomization
Feasibility defined as ≥ 90% of enrolled families successfully completing baseline measures and proceeding to randomization
Measured: At 4 weeks
Percentage of randomized families completing the study
Feasibility defined as ≥ 85% of randomized families completing the study.
Measured: At 4 weeks
Participant reported interest in continuing to engage in program over a longer period of time.
As reported by participants by Phone call
Measured: At 4 weeks
Secondary outcomes (2)
Change in household grocery purchases: nutritional quality
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
Measured: From baseline to end of study - up to 4 weeks
Changes in household grocery purchases: energy content
Total energy content of groceries purchased for the household each week
Measured: UP to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Nov 2028 (estimated)
- Study completion2 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kara Kelly, MD, Principal investigator, Roswell Park Comprehensive Cancer CenterStephanie Anzman-Frasca, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901816
- Sponsor's protocol ID
- I-5069026
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an Optimal Defaults Grocery Shopping Intervention to Promote Healthy Diets in the Context of Pediatric Cancer Survivorship
- ClinicalTrials.gov ID
- NCT07901816
- Acronym / sponsor ID
- I-5069026
- Conditions
- Pediatric
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Nov 2028 (estimated)
- Study completion
- 2 Nov 2029 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Main Meal Recipes | Active comparator | Other: Dietary Intervention - meal recipes, Other: Informational Intervention, Other: Educational InterventionFamilies (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. |
| Group 2 - Main meal recipes, prefilled grocery cart | Experimental | Other: Dietary Intervention - meal recipes, Other: Educational Intervention, Other: Dietary Intervention - prefilled grocery cartFamilies (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 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (2 listed)
- Parent is unwilling or unable to follow protocol requirements
- Not meeting above inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Intervention - meal recipesReceive main meal recipes | Other | Group 1 - Main Meal Recipes, Group 2 - Main meal recipes, prefilled grocery cart |
| Informational InterventionMeet with study staff to address any grocery shopping questions | Other | Group 1 - Main Meal Recipes |
| Educational InterventionReceive nutrition education tips | Other | Group 1 - Main Meal Recipes, Group 2 - Main meal recipes, prefilled grocery cart |
| Dietary Intervention - prefilled grocery cartReceive prefilled online grocery cart | Other | Group 2 - Main meal recipes, prefilled grocery cart |
Primary outcome
Retention Rate
Time frame: At 4 weeks
Percentage of study cohort who complete the study
Percentage of Interested families Eligible for study
Time frame: At 4 weeks
Feasibility defined as ≥ 50% of interested families being eligible for the study
Percentage of eligible families enrolling in study
Time frame: At week 4
Feasibility defined as ≥ 50% of eligible families enrolling
Percent of enrolled families completing baseline measures and proceeding to randomization
Time frame: 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
Time frame: 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.
Time frame: At 4 weeks
As reported by participants by Phone call
2 secondary outcomes
Change in household grocery purchases: nutritional quality
Time frame: From baseline to end of study - up to 4 weeks
Changes in household grocery purchases: energy content
Time frame: UP to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kara Kelly, MD principal investigator
Roswell Park Comprehensive Cancer Center
Stephanie Anzman-Frasca, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention - meal recipes, Informational Intervention and Educational Intervention in people with Pediatric, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASK ROSWELLPARK (800-767-9355, ASKROSWELL@Roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (time frame: At 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.