- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05899634
The Family Grocery Pilot: Optimal Defaults in Online Grocery Shopping Among Families (FGS)
The Family Grocery Pilot: Examining the Use of Optimal Defaults in Online Grocery Shopping Among Families With 2-to-5-year-old Children.
Study Overview
Detailed Description
The goal of the proposed pilot study is to examine the feasibility and efficacy of a new family-based approach to early childhood obesity prevention, using optimal defaults in the form of pre-filled, default online grocery shopping carts to promote healthier grocery shopping among families with young children at risk for obesity. The specific aims are to: (1) test the feasibility and efficacy of a Defaults grocery shopping intervention designed to promote healthier grocery purchases among families with obesity, and (2) test effects of this intervention on the home food environment and dietary intake. To do this a randomized controlled intervention study has been designed, in which all study participants will receive 3 healthy recipes each week of a two-week intervention period, and intervention group will have their online grocery shopping carts pre-filled with corresponding ingredients.
Families who already grocery shop online and who have a 2-to-5-year-old child at home who is at increased obesity risk based on parental weight status will be randomly assigned to the intervention (Defaults) or control (Recipes) group. At baseline, all participants will complete a survey online and then will grocery shop as usual for two weeks. The baseline period will also serve as a run-in period, and participants who do not comply with study guidelines for baseline procedures will not be randomized for further participation. Participants will then be randomized and enter a two-week intervention period. During this period, all participants will be given recipe cards (3 main meal recipes + 1 snack/breakfast recipe each week), featuring healthful, budget friendly meals developed by dietitians. The Recipes group will continue to grocery shop as normal. The Defaults group will have their online shopping carts pre-filled with the study recipe ingredients. They will be told their cart has been filled with those items that could be used to make the healthful recipes on the recipe cards given to them. They may modify their carts as they choose. It is hypothesized that the Defaults group will have weekly grocery purchases with greater nutritional quality and lower energy content, compared to the Recipes group. It is hypothesized that the Defaults group will also have a home food environment with a greater nutritional quality score than the Recipes (via the Healthy Eating Index). Dietary intake of parents and children in the Defaults group will also have a higher nutritional quality, compared to the Recipes group, as indicated by food photography during 3 dinner meals during the intervention period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14214
- State University of New York at Buffalo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participating parent/guardian must be at least 18 years old
- Must have a 2-to-5-year-old child in the household
- Must grocery shop online (via Instacart) from Tops, Wegmans, and/or Aldi stores at least 75% of the time
- Child must have at least one parent/guardian meeting criteria for overweight/obesity (BMI >25)
- Must speak English
Exclusion Criteria:
- Parent/guardian is under 18 years of age
- Does not have at least one 2-to-5-year-old child living in the household
- Does not shop online at Tops, Wegmans, and/or Aldi stores at least 75% of the time
- Child does not have at least one parent/guardian meeting criteria for overweight/obesity
- Does not speak English
- Has dietary restrictions or preferences that would not allow them to reasonably partake in the study (i.e., they would not be willing or able to buy/eat many of the staple foods included in default carts/recipe cards)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group 1 - Recipes
Participants will receive healthy recipes (3 main meal + 1 snack/breakfast/lunch recipe per week of the two-week intervention).
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|
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Experimental: Group 2 - Default
Participants will receive healthy recipes (3 main meal + 1 snack/breakfast/lunch recipe per week of the two-week intervention).
In addition, in this group, participants' online grocery shopping carts will be pre-filled with ingredients corresponding to the provided recipes.
They will be told that their cart has been filled with items that can be used to make recipes from the provided recipe cards, and that they can modify it as they like.
|
Participants will receive healthy recipes (3 main meal + 1 snack/breakfast/lunch recipe per week of the two-week intervention).
In addition, in this group, participants' online grocery shopping carts will be pre-filled with ingredients corresponding to the provided recipes.
They will be told that their cart has been filled with items that can be used to make recipes from the provided recipe cards, and that they can modify it as they like.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutritional Quality of Purchases in First Intervention Week
Time Frame: Intervention (Week 3)
|
Receipt data from target grocery stores will be entered into nutrition software and used to quantify the number of foods purchased weekly for the household that correspond to Healthy Eating Index (HEI) food groups (e.g., fruits, dark green vegetables).
These scores will be operationalized such that higher scores indicate more healthful food purchases aligning with HEI scoring.
|
Intervention (Week 3)
|
|
Nutritional Quality of Purchases in Second Intervention Week
Time Frame: Intervention (Week 4)
|
Receipt data from target grocery stores will be entered into nutrition software and used to quantify the number of foods purchased weekly for the household that correspond to HEI food groups (e.g., fruits, dark green vegetables).
These scores will be operationalized such that higher scores indicate more healthful food purchases aligning with HEI scoring.
|
Intervention (Week 4)
|
|
Change in Nutritional Quality of Purchases
Time Frame: Baseline (Weeks 1 and 2) and Intervention (Weeks 3 and 4)
|
Receipt data from target grocery stores will be entered into nutrition software and used to quantify the number of foods purchased weekly for the household that correspond to HEI food groups (e.g., fruits, dark green vegetables).
These scores will be operationalized such that higher scores indicate more healthful food purchases aligning with HEI scoring.
|
Baseline (Weeks 1 and 2) and Intervention (Weeks 3 and 4)
|
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Energy Purchased in First Intervention Week
Time Frame: Intervention (Week 3)
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Receipt data from target grocery stores will be entered into nutrition software and used to calculate the total weekly calories purchased from target grocery stores.
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Intervention (Week 3)
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Energy Purchased in Second Intervention Week
Time Frame: Intervention (Week 4)
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Receipt data from target grocery stores will be entered into nutrition software and used to calculate the total weekly calories purchased from target grocery stores.
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Intervention (Week 4)
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Change in Energy Purchased
Time Frame: Baseline (Weeks 1 and 2) and Intervention (Weeks 3 and 4)
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Receipt data from target grocery stores will be entered into nutrition software and used to calculate the total weekly calories purchased from all grocery stores.
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Baseline (Weeks 1 and 2) and Intervention (Weeks 3 and 4)
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Cost of Groceries in First Intervention Week
Time Frame: Intervention (week 3)
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Total weekly dollars spent on grocery purchases from submitted receipts from target grocery stores
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Intervention (week 3)
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Cost of Groceries in Second Intervention Week
Time Frame: Intervention (week 4)
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Total weekly dollars spent on grocery purchases from submitted receipts from target grocery stores
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Intervention (week 4)
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Change in Cost of Groceries
Time Frame: Baseline (Weeks 1 and 2) and Intervention (Weeks 3 and 4)
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Total weekly dollars spent on grocery purchases from submitted receipts from target grocery stores
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Baseline (Weeks 1 and 2) and Intervention (Weeks 3 and 4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutritional Quality of Home Food Environment
Time Frame: Intervention (Week 4)
|
Data from a home food inventory will be used to create an HEI score based on the presence or absence of foods corresponding to HEI food groups (e.g., fruits, dark green vegetables).
These scores will be operationalized such that higher scores indicate more healthful foods present in the home aligning with HEI scoring.
|
Intervention (Week 4)
|
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Meals and Meal Intake of Parent
Time Frame: Intervention (Week 4)
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Data from the food photographs will be used to create an HEI score based on the parent's consumption of foods (i.e., whether or not a food was consumed in any amount) which correspond to HEI food groups (e.g., fruits, dark green vegetables).
These scores will be operationalized such that higher scores indicate more healthful foods present in the home aligning with HEI scoring.
|
Intervention (Week 4)
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Meals and Meal Intake of Child
Time Frame: Intervention (Week 4)
|
Pre and post-meal photos with descriptions from children will be used to assess what foods are offered and quantify (1) if any of the foods were consumed and (2) the amount consumed (as a percentage) of individual foods offered during each of three dinner meals.
Consumption of foods offered will be entered into nutrition software to calculate an estimate of calories consumed.
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Intervention (Week 4)
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Nutritional Quality of Child's Intake
Time Frame: Intervention (Week 4)
|
Data from the food photographs will be used to create an HEI score based on the child's consumption of foods (i.e., whether or not a food was consumed in any amount) which correspond to HEI food groups (e.g., fruits, dark green vegetables).
These scores will be operationalized such that higher scores indicate more healthful foods present in the home aligning with HEI scoring.
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Intervention (Week 4)
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Collaborators and Investigators
Investigators
- Principal Investigator: Stephanie Anzman-Frasca, PhD, University at Buffalo
- Principal Investigator: Mackenzie J Ferrante, PhD, University at Buffalo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00007317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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