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NCT Number: NCT07806721

Family Grocery Study R01

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.

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Key information

Conditions

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

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Recipes

Behavioral

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

Pre-filled carts

Behavioral

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.

Primary outcomes

  1. Nutritional quality of household grocery purchases

    Time frame: 6 months

    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.

  2. Energy content of household grocery purchases

    Time frame: 6 months

    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.

  3. Fruits purchased

    Time frame: 6 months

    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.

  4. Vegetables purchased

    Time frame: 6 months

    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.

  5. High energy dense foods purchased

    Time frame: 6 months

    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).

Secondary outcomes

  1. Nutritional quality of child intake

    Time frame: 6 months

    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.

  2. Nutritional quality of parent intake

    Time frame: 6 months

    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.

  3. Energy content of child intake

    Time frame: 6 months

    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.

  4. Energy content of parent intake

    Time frame: 6 months

    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.

  5. Child fruit intake

    Time frame: 6 months

    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.

  6. Parent fruit intake

    Time frame: 6 months

    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.

  7. Child vegetable intake

    Time frame: 6 months

    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.

  8. Parent vegetable intake

    Time frame: 6 months

    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.

  9. Child energy density of intake

    Time frame: 6 months

    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.

  10. Parent energy density of intake

    Time frame: 6 months

    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.

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Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Independent Health Foundation
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Pennington Biomedical Research Center
  • Rutgers University

Registry information

Official study title

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

Acronym: FGS2

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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