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ObesityFGS2NCT07806721

Family Grocery Study R01

A study testing Recipes and Pre-filled carts in people with Obesity and Diet, Healthy, run by State University of New York at Buffalo.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Obesity continues to be a major public health concern, and children who are overweight by age 5 are at increased risk for future obesity, highlighting the importance of early efforts to promote healthy eating and growth. Read more about this study

Who is it for?
Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Diet, Healthy
What is being tested?
Recipes and Pre-filled carts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
384 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 31 Dec 2030
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

  • The participating adult must be >18 years old
  • Participating adult is English speaking
  • Participating adult has a self-reported body mass index >30
  • Participating adult has a 2-to-5-year-old child
  • The participant also must report online grocery shopping from study stores (Aldi, Tops, Wegman's, and/or Walmart) at least 2 times per month
  • Willing to purchase fresh foods online (e.g., fruits, vegetables, meat if meat is consumed), vs. using online shopping solely for shelf-stable pantry staples.
  • Participants also must be a primary caregiver of the enrolled child
  • Do greater than or equal to 75% of their grocery shopping from study stores and at least 50% of the grocery shopping for the family.

Who cannot join

  • Families in which the child is underweight (BMI-for-age percentile <5) will be excluded
  • There must not be family dietary restrictions that preclude being able to use at least some recipes in the study's recipe bank.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jack McGowan, MS contact

7168296691

jem53@buffalo.edu

Stephanie Anzman-Frasca, MS contact

7168296692

safrasca@buffalo.edu

About this study

Official title: Promoting Healthy Dietary Intake Among Families With Obesity Via a Grocery Shopping Intervention

Obesity continues to be a major public health concern, and children who are overweight by age 5 are at increased risk for future obesity, highlighting the importance of early efforts to promote healthy eating and growth. The goal of this project is to test a new family-based approach to early childhood obesity prevention, specifically using pre-filled, online grocery shopping carts to make it easier for parents to select healthy foods like fruits and vegetables. This study will be the first to test whether such default shopping carts can help promote the purchasing and consumption of healthier foods, as well as healthier diets and weight outcomes, among parents with obesity and their 2-to-5-year-old children, offering the potential for a meaningful impact on the health of young children and their families.

Read the detailed description

Obesity is a diet-related disease that continues to be a major public health concern. Children who are overweight by age 5 are at increased risk for future obesity, highlighting the importance of early efforts to promote healthy diets. Modifying home food availability can impact the diets of children and their families, and online grocery shopping offers untapped potential as a way to modify the family food environment. The objective of this grant is to test a new family-based approach to early obesity prevention, specifically using optimal defaults to promote healthier online grocery shopping. Making "optimal" choices easier by making them the default option has strong scientific support, but this strategy has not been implemented in the context of online grocery shopping on a large scale. The study team's preliminary research demonstrated the potential of pre-filling online grocery shopping carts with nutritious foods: this default grocery cart strategy had significant, positive effects on the nutritional quality of grocery purchases in two pilot studies. The proposed study will expand upon this preliminary research, recruiting 192 parents with obesity who use online grocery shopping and have a 2-to-5-year-old child. Families will be randomly assigned to a default grocery cart intervention or control group. Both groups will be provided with 4 main meal recipes and 4 lunch and/or snack recipes each week of a 6-month intervention period, with recipes corresponding to the Traffic Light Diet, an evidence-based diet for family-based obesity prevention and treatment. Corresponding nutritional guidance will be provided, with a goal to increase low energy-dense, high nutrient-dense foods and decrease the energy density of the diet. In addition, the defaults group's online grocery carts will be pre-filled with items that correspond to the provided recipes each week. Participants can alter these carts as they like. Assessments will occur via grocery receipt forms, phone interviews, remote food photography, height/weight measurements, and online surveys. Hypotheses corresponding to primary and secondary aims are: It is hypothesized that the defaults group will have household grocery purchases that are better-aligned with dietary goals (e.g., more fruits and vegetables, higher nutritional quality, fewer calories) (Aim 1), and that participating parents and 2-to-5-year-old children will have healthier dietary intake (e.g., more fruits and vegetables, higher nutritional quality, fewer calories) than controls (Aim 2) following the 6-month intervention. These aims are designed to leverage a simple but powerful behavioral principle, optimal defaults, to make purchasing of healthier foods easier among families with young children during a period of the life span in which dietary preferences and future weight trajectories are being established. In the long-term, this research offers the potential for a scalable, sustainable approach to facilitate healthier dietary intake among a broad population of individuals and families at risk for diet-related diseases.

Being tested
Recipes, Pre-filled carts
Keywords
children, diet, grocery shopping
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RecipesBehavioural

    Packet of healthy recipes provided each week of a 6-month intervention, with nutrition education and healthy eating tips included.

  • Pre-filled cartsBehavioural

    Participants' online grocery carts are pre-filled with the ingredients from the main meal recipes featured in provided recipe packets that week. Participants can change these carts as they like.

Study groups in NCT07806721
Study groupRoleWhat they receive
Recipes onlyActive comparatorFamilies in this group will receive a packet of healthy recipes during each week of a 6-month intervention. Recipe packets will also include nutrition education.
Receives: Behavioral: Recipes
Pre-filled cartsExperimentalFamilies in this group will receive a packet of healthy recipes during each week of a 6-month intervention. Recipe packets will also include nutrition education. In addition, each week of the intervention, their online grocery carts will be pre-filled with the ingredients to make the main meal recipes featured in the recipe packets that week. Participants can alter their carts as they like and determine which groceries they will purchase.
Receives: Behavioral: Recipes; Behavioral: Pre-filled carts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nutritional quality of household grocery purchases

    Nutritional quality of household grocery purchases will be coded in accordance with the Healthy Eating Index and will include all groceries purchased that time point (online or in-person, etc.). Grocery purchases are scored in 13 categories from the Healthy Eating Index, with quintiles used to operationalize lower versus higher purchasing of these categories (ex. fruits, vegetables, whole grains), with a resulting possible nutritional quality range of 13-65. Two weeks of data collection occur per time point, and values are averaged to represent the average weekly nutritional quality of grocery purchases at that time point. Analyses will compare the nutritional quality of grocery purchases between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, in the context of marginal models adjusting for baseline nutritional quality, stratification factors, and household size.

    Measured: 6 months

  2. Energy content of household grocery purchases

    Energy content will be operationalized across all household grocery purchases in kcal. Two weeks of data collection occur per time point, and values are averaged to represent the average weekly energy content of grocery purchases at that time point. Analyses will compare the energy content of grocery purchases between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, in the context of marginal models adjusting for baseline energy content, stratification factors, and household size.

    Measured: 6 months

  3. Fruits purchased

    The number of different types of fruits purchased will be operationalized across all household grocery purchases. Two weeks of data collection occur per time point, and values are averaged to represent average number of fruits purchased. Analyses will compare fruits purchased between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline fruit purchasing, stratification factors, and household size.

    Measured: 6 months

  4. Vegetables purchased

    The number of different types of vegetables purchased will be operationalized across all household grocery purchases. Two weeks of data collection occur per time point, and values are averaged to represent average number of vegetables purchased. Analyses will compare vegetables purchased between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline vegetable purchasing, stratification factors, and household size.

    Measured: 6 months

  5. High energy dense foods purchased

    The number of different types of high energy dense foods purchased will be operationalized across all household grocery purchases. Two weeks of data collection occur per time point, and values are averaged to represent average number of high energy dense foods purchased. Analyses will compare high energy dense foods purchased between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline high energy dense food purchasing, stratification factors, and household size. High energy dense foods are coded based on cut-offs from the Traffic Light Diet (e.g., sugar >25% of calories/serving).

    Measured: 6 months

Secondary outcomes (10)
  1. Nutritional quality of child intake

    Nutritional quality of children's intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Nutritional quality of the foods consumed will be calculated in accordance with the Healthy Eating Index and aggregated across the 3 days of evening meal data collection. Analyses will compare nutritional quality of evening meal intake between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline nutritional quality of intake and stratification factors.

    Measured: 6 months

  2. Nutritional quality of parent intake

    Nutritional quality of parent's intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Nutritional quality of the foods consumed will be calculated in accordance with the Healthy Eating Index and aggregated across the 3 days of evening meal data collection. Analyses will compare nutritional quality of evening meal intake between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline nutritional quality of intake and stratification factors.

    Measured: 6 months

  3. Energy content of child intake

    Energy content of children's intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Energy consumed at the meal is aggregated across the 3 days of evening meal data collection. Analyses will compare energy consumed at the evening meal between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline energy content of intake and stratification factors. Energy consumed is in kcal.

    Measured: 6 months

  4. Energy content of parent intake

    Energy content of parent's intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Energy consumed at the meal is aggregated across the 3 days of evening meal data collection. Analyses will compare energy consumed at the evening meal between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline energy content of intake and stratification factors. Energy consumed is in kcal.

    Measured: 6 months

  5. Child fruit intake

    Child fruit intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Number of different fruits consumed at the meal is aggregated across the 3 days of evening meal data collection. Analyses will compare fruit intake between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline fruit intake and stratification factors.

    Measured: 6 months

  6. Parent fruit intake

    Parent fruit intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Number of different fruits consumed at the meal is aggregated across the 3 days of evening meal data collection. Analyses will compare fruit intake between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline fruit intake and stratification factors.

    Measured: 6 months

  7. Child vegetable intake

    Child vegetable intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Number of different vegetables consumed at the meal is aggregated across the 3 days of evening meal data collection. Analyses will compare vegetable intake between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline vegetable intake and stratification factors.

    Measured: 6 months

  8. Parent vegetable intake

    Parent vegetable intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Number of different vegetables consumed at the meal is aggregated across the 3 days of evening meal data collection. Analyses will compare vegetable intake between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline vegetable intake and stratification factors.

    Measured: 6 months

  9. Child energy density of intake

    Child energy density of intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Energy density is calculated as kcal consumed relative to volume consumed (g) and aggregated across the 3 days of evening meal data collection for daily energy density of intake. Analyses will compare energy density of intake between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline energy density of intake and stratification factors.

    Measured: 6 months

  10. Parent energy density of intake

    Parent energy density of intake is measured using remote food photography during 3 evening meals per time point. Trained raters analyze images of foods before and after the meal and quantify food intake. Energy density is calculated as kcal consumed relative to volume consumed (g) and aggregated across the 3 days of evening meal data collection for daily energy density of intake. Analyses will compare energy density of intake between groups at the primary outcome time point of 6 months, immediately after the conclusion of the intervention, adjusting for baseline energy density of intake and stratification factors.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
384 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07806721
Sponsor's protocol ID
STUDY00010584
Other IDs
1R01DK148167
Acronym
FGS2
Status last verified
Sep 2026
First submitted
1 Sep 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to share deidentified data corresponding to quantitative study outcome variables through a public repository as specified in the Data Management and sharing Plan.

Questions about this trial

What is this clinical trial studying?

A study testing Recipes and Pre-filled carts in people with Obesity and Diet, Healthy, run by State University of New York at Buffalo.

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 8 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Jack McGowan, MS (7168296691, jem53@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional quality of household grocery purchases (time frame: 6 months). The study lists 5 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 8 Sep 2026.

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