Understanding Food Choices (Aim 2)

Diet Quality Clinical Trial

Official title:

Multiphase Optimal Strategy To Improve Diet Quality-MOSTDQ (Aim 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05537337
• Other study ID #: MOH-000263 (Aim 2)
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: October 16, 2023

Study information

• Verified date: February 2024
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to use the Multiphase Optimization Strategy (MOST) to build and optimize a multicomponent intervention that improves diet quality. The investigators have evaluated the effects of evidence-based public health interventions on consumers' diet quality via a web-based grocery store "NUSMart" as part of Aim 1 of this study. Considering that the goal is to identify promising interventions that may optimize online grocery platforms, the investigators used Aim 1's results to assemble a multicomponent intervention that would significantly affect diet quality: a combination of three behavioral nudges that include food labels & real-time feedback, ordering, and healthier substitute offers (a subset of the interventions examined in Aim 1). Aim 2 study aims to rigorously evaluate this multicomponent intervention.

Description:

The important role that diet plays in health and disease is well established. Excessive intake of energy, saturated fat and sodium increase the risk of heart disease, diabetes and certain cancers. As a result, interventions aimed at encouraging healthier food consumption have been pursued by many countries. These can be broadly grouped into the following categories: price manipulations, food labelling, and behavioral nudges.

No study has previously assessed the potentially interactive effects of a multicomponent intervention that incorporates the strongest features of each intervention component while discarding those that do not meaningfully contribute to healthier consumption. That is the goal of this effort.

At part of the first stage of the MOST framework (Aim 1), the investigators evaluated the effects of evidence-based public health interventions on consumers' diet quality on a web-based grocery store "NUSMart". The investigators focused on the following four interventions: 1. Explicit Tax, 2. Food labels (with the summary of healthiness of shopping baskets & targets), 3. Ordering and 4. Within Group Healthier Substitution. Based on the study results, the investigators assembled a multicomponent intervention that consists of a subset of the above four interventions that may optimize online grocery platforms in terms of diet improvement.

The multicomponent intervention consists of the following components:

1. Food labels (with the summary of healthiness of shopping baskets & targets)- Food labels, called Nutri-Traffic-Lights (NTL), indicating whether food and beverage products were healthy, unhealthy or somewhere in between were designed for all products on NUSMart based on the Nutri-Score Nutrition Scoring System. These were supplemented with a video explaining the labels and a dynamic pie chart indicating the overall nutritional quality of the shopper's basket (updated in real time) known as MyCart summary.

2. Ordering- Healthier products, in terms of Nutri-Score Points, were displayed first within each category and subcategory.

3. Within Group Healthier Substitution- At checkout, up to 4 healthier substitutes were suggested for products in the shopper's cart based on the Nutri-Score Points of these products. Substitutes were from the same category as the product that was added to cart and were close to the original product in terms of price as well.

In this study (Aim 2), using a 2-arm randomized controlled trial, the investigators will test whether the assembled multicomponent intervention has a sustained positive effect on diet quality over 3 purchases over a 3-5-week period, wherein the purchased foods are delivered to the participants' homes.

Over the course of the study, participants will log into the NUSMart website once a week and will be asked to purchase their weekly groceries with a minimum spend of $59. Each participant will therefore shop a total of 3 times using the same version of NUSMart randomly assigned to them, during the study.

The investigators' hypotheses about the effects of the multicomponent intervention on diet quality, measured by the weighted (by the number of servings) average Nutri-Score Points (primary) of finalized shopping baskets, are as follows:

1. The multicomponent intervention will significantly improve diet quality as measured by the weighted Nutri-Score Points (primary), calories, sodium, sugar, and saturated fat per serving, which will be calculated based on all purchased products' total nutritional value.

2. The improvements in diet quality will be sustained through repeated shops where food is actually delivered, thus making it more likely that results are externally valid.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Singapore resident

• Age 21 and above

• Must be the primary weekly grocery shopper in their household

Exclusion Criteria:

• Non-Singapore resident

• Less than 21 years old

• Non-primary grocery shopper in their household

Related Conditions & MeSH terms

• Diet Quality

Intervention

Behavioral:
• Multicomponent Intervention
The multicomponent intervention consists of the following components (already described in the detailed description section): Food labels (with the summary of healthiness of shopping baskets & targets) Ordering Within Group Healthier Substitution

Locations

Country	Name	City	State
Singapore	Duke-NUS Graduate Medical School	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mediators, Moderators and Covariates	We will run models both with and without including covariates that include demographic variables (e.g., age, minority status, income, BMI, sex, and household size) and measurements of health-status. To test the moderating effects of health-status, and education level, we will include interaction terms between the intervention arm and these variables.	After completion of data collection, an average of about 14 months
Primary	Diet Quality	Diet quality measured by the weighted (by the number of servings) average of all purchased products' Nutri-Score Points for the shopping trip. Nutri-Score Points is an individual dietary index based on the British Food Standard Agency Nutrient Profiling System. Nutri-Score points are calculated by scoring food and beverage products on a scale from -15 (healthiest) to 40 (least healthy) by subtracting the sum of Nutri-Score sub-points for healthier components (e.g., fiber, protein, percentage of fruits & vegetables) from the sum of Nutri-Score sub-points for less healthy components (e.g., energy, sugar, sodium, saturated fat). The final non-numeric grade, A to E, is determined based on carefully designed thresholds for these resulting Nutri-Score Points.	After completion of data collection, an average of about 14 months
Secondary	Nutrients per serving	Average calories, sodium, sugar, and saturated fat per serving, which will be calculated based on all purchased products' total nutritional value.	After completion of data collection, an average of about 14 months
Secondary	Proportion of products for each Nutri-Traffic-Light (NTL) classification	The proportion of products eligible for each of the 3 classifications of the NTL (i.e., the green circle, the amber circle and the red stop-sign) respectively, of the purchased products.	After completion of data collection, an average of about 14 months