Family Grocery Study R01
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorState University of New York at Buffalo
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Recipes
BehavioralPacket of healthy recipes provided each week of a 6-month intervention, with nutrition education and healthy eating tips included.
Pre-filled carts
BehavioralParticipants' 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.
Treatment groups
384 Participants
are divided into 2 treatment groupsGroup A: Recipes onlyActive comparator 1 intervention
Group B: Pre-filled cartsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
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.
Time frame
6 months2
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.
Time frame
6 months3
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.
Time frame
6 months4
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.
Time frame
6 monthsSecondary outcomes
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.
Time frame
6 months2
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.
Time frame
6 months3
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.
Time frame
6 months4
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.
Time frame
6 monthsLocations
Sponsors and contacts
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State University of New York at Buffalo
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Independent Health Foundation
Collaborator
Rutgers University
Collaborator
Pennington Biomedical Research Center
Collaborator
Source ClinicalTrials.gov
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