Diet QualityNCT04632212
Understanding Food Choices
A study testing Explicit Tax, Food Labels (with the summary of healthiness of shopping baskets & targets) and Ordering in people with Diet Quality, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
This study aims to use the Multiphase Optimization Strategy (MOST) to build and optimize a multi-component intervention that improves diet quality. The investigators will evaluate the effects of evidence-based public health interventions on consumers' diet quality via a web-based grocery store "NUSMart" and then… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Quality
- What is being tested?
- Explicit Tax, Food Labels (with the summary of healthiness of shopping baskets & targets) and Ordering
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Dec 2020to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singapore Resident
- Age 21 and above
- Must be the primary weekly grocery shopper in their household
Who cannot join
- Non-Singapore resident
- Less than 21 years old
- Non-primary grocery shopper in their household
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiphase Optimal Strategy To Improve Diet Quality-MOSTDQ (Aim 1)
This study aims to use the Multiphase Optimization Strategy (MOST) to build and optimize a multi-component intervention that improves diet quality. The investigators will evaluate the effects of evidence-based public health interventions on consumers' diet quality via a web-based grocery store "NUSMart" and then identify a multi-component intervention that includes only those interventions meaningfully affecting diet quality.
Read the detailed 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 labeling, and behavioral nudges.
No study has previously assessed the potentially interactive effects of a multi-component 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.
To this end, the investigators chose a full-factorial design because this experimental design allows us to estimate not only the independent (main) effects of the interventions but also their interaction effects. The full-factorial design includes all possible combinations of the interventions' status. Because the investigators have four interventions, each of which has two levels (intervention On or Off), there are 16 (i.e. 2^4) experimental conditions/arms in total. The four interventions for this study are outlined below:
- Explicit Tax: To impose an explicit tax on food and beverage items that are eligible for red stop-sign (explained in b.) as less healthy foods.
Foods and Beverages: The investigators will impose a 20% tax on sales price of the food items.
- Food Labels (with the summary of healthiness of shopping baskets \& targets): To provide the green circle 'healthy choice' food label to items with Nutri-Score "A" and "B", the amber circle 'in between healthy and unhealthy choice' food label to items with Nutri-Score "C", and the red stop-sign 'Unhealthy choice' food label to items with Nutri-Score "D" and "E". In the presence of food labels, before shopping, subjects will watch a video briefly explaining the food labels on the store and be provided a live visual indicator of the healthiness of shoppers' current basket (called "My Cart Summary") with the recommended healthy baskets goals (i.e., Green logo products ≥ 60% and Red logo products ≤ 15% of the weighted number of servings of products.). My Cart Summary will be displayed as a pie chart with the proportion of servings in their current shopping baskets, according to the three food labels. This way, as shoppers add to their basket while browsing the store, they will have visual feedback on how their latest addition contributes to their total basket healthiness.
- Ordering: To order food items by Nutri-Score such that healthier items are shown upfront on NUSMart.
- Within Group Substitution: At the checkout, to provide consumers with an opportunity to replace their original items with an item chosen from two or four recommended substitutes that are healthier within their corresponding food categories based on the similarities of price, ingredients, flavor, and other characteristics.
Participants will be randomly assigned to one of the 16 arms and instructed to perform a one-time hypothetical grocery shopping on NUSMart.
The investigators will collect participants' demographic and health characteristics as well as hunger at the time of the survey and their self-control in the baseline survey. The collected data will be used to precisely estimate the causal effect of the interventions and address their underlying mechanism to change consumers' food choices.
Our hypotheses about the effects of the interventions on diet quality, measured by the weighted average Nutri-Score (primary) of finalized shopping baskets, are as follows:
- There will be significant and positive main effects of each of the interventions.
- There will be significant and positive interaction effects on diet quality of: Explicit tax \& food labels, Food labels \& ordering.
We will also 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 self-control, hunger, and health-status. To test the moderating effects of hunger, self-control, health-status, and education level, we will include interaction terms between the intervention arms and these variables.
- Conditions
- Diet Quality
- Being tested
- Explicit Tax, Food Labels (with the summary of healthiness of shopping baskets & targets), Ordering, Within-Group Substitution
- Keywords
- Multi-component Intervention, Multi-phase Optimization Strategy, Tax, Food Labels, Quality based ordering, Within group substitutes, Full-factorial design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explicit TaxBehavioural
To impose an explicit tax on food and beverage items that are eligible for red stop-sign food logos (explained in Intervention 2) as less healthy foods. Explicit tax shows pre-tax prices and a label indicating that the price includes a corresponding tax on the less healthy products.
Food and Beverages: we will impose a 20% tax on sales price of the food items
Food Labels (with the summary of healthiness of shopping baskets & targets)Behavioural
To provide the green circle 'healthy choice' food label to items with Nutri-Score "A" and "B", the amber circle 'in between healthy and unhealthy choice' food label to items with Nutri-Score "C", and the red stop-sign 'less healthy choice' food label to items with Nutri-Score "D" and "E".
In the presence of food labels,
- Video: subjects will watch a video briefly explaining the food labels on the store.
- My Cart Summary: subjects will be provided a live visual indicator of the healthiness of shoppers' current basket with the recommended healthy baskets goals.
OrderingBehavioural
To order food items by Nutri-Score (high to low).
Within-Group SubstitutionBehavioural
To provide substitutes within corresponding food categories that are better than the items that subjects chose in terms of Nutri-Score based on the similarities of price, primary ingredients, flavor, and other characteristics.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tax (ON) Food Labels (ON) Ordering (ON) Substitution (ON) Receives: Behavioral: Explicit Tax; Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets); Behavioral: Ordering; Behavioral: Within-Group Substitution |
| 2 | Experimental | Tax (ON) Food Labels (ON) Ordering (ON) Substitution (OFF) Receives: Behavioral: Explicit Tax; Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets); Behavioral: Ordering |
| 3 | Experimental | Tax (ON) Food Labels (ON) Ordering (OFF) Substitution (ON) Receives: Behavioral: Explicit Tax; Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets); Behavioral: Within-Group Substitution |
| 4 | Experimental | Tax (ON) Food Labels (ON) Ordering (OFF) Substitution (OFF) Receives: Behavioral: Explicit Tax; Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets) |
| 5 | Experimental | Tax (ON) Food Labels (OFF) Ordering (ON) Substitution (ON) Receives: Behavioral: Explicit Tax; Behavioral: Ordering; Behavioral: Within-Group Substitution |
| 6 | Experimental | Tax (ON) Food Labels (OFF) Ordering (ON) Substitution (OFF) Receives: Behavioral: Explicit Tax; Behavioral: Ordering |
| 7 | Experimental | Tax (ON) Food Labels (OFF) Ordering (OFF) Substitution (ON) Receives: Behavioral: Explicit Tax; Behavioral: Within-Group Substitution |
| 8 | Experimental | Tax (ON) Food Labels (OFF) Ordering (OFF) Substitution (OFF) Receives: Behavioral: Explicit Tax |
| 9 | Experimental | Tax (OFF) Food Labels (ON) Ordering (ON) Substitution (ON) Receives: Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets); Behavioral: Ordering; Behavioral: Within-Group Substitution |
| 10 | Experimental | Tax (OFF) Food Labels (ON) Ordering (ON) Substitution (OFF) Receives: Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets); Behavioral: Ordering |
| 11 | Experimental | Tax (OFF) Food Labels (ON) Ordering (OFF) Substitution (ON) Receives: Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets); Behavioral: Within-Group Substitution |
| 12 | Experimental | Tax (OFF) Food Labels (ON) Ordering (OFF) Substitution (OFF) Receives: Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets) |
| 13 | Experimental | Tax (OFF) Food Labels (OFF) Ordering (ON) Substitution (ON) Receives: Behavioral: Ordering; Behavioral: Within-Group Substitution |
| 14 | Experimental | Tax (OFF) Food Labels (OFF) Ordering (ON) Substitution (OFF) Receives: Behavioral: Ordering |
| 15 | Experimental | Tax (OFF) Food Labels (OFF) Ordering (OFF) Substitution (ON) Receives: Behavioral: Within-Group Substitution |
| 16 | No intervention | Tax (OFF) Food Labels (OFF) Ordering (OFF) Substitution (OFF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Quality
Diet quality measured by the weighted average of all purchased products' Nutri-Score for the shopping trip. Nutri-Score is an individual dietary index based on the British Food Standard Agency Nutrient Profiling System.
Measured: At the end of data collection, up to 8 weeks
Secondary outcomes (2)
Proportion of products
The proportion of products eligible for the green circle label and the red stop-sign label respectively, of the purchased products.
Measured: At the end of data collection, up to 8 weeks
Average nutrients per serving
Average calories, sodium, sugar, fat, and saturated fat per serving, which will be calculated based on all purchased products' total nutritional value.
Measured: At the end of data collection, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start2 Dec 2020
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Eric A. Finkelstein, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632212
- Sponsor's protocol ID
- MOH-000263
- Status last verified
- Feb 2021
- First submitted
- 2 Nov 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin S, Chakraborty B, Yan X, van Dam RM, Finkelstein EA. Evaluation of Combinations of Nudging, Pricing, and Labeling Strategies to Improve Diet Quality: A Virtual Grocery Store Experiment Employing a Multiphase Optimization Strategy. Ann Behav Med. 2022 Aug 30;56(9):933-945. doi: 10.1093/abm/kaab115.
PubMed 35195704
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiphase Optimal Strategy To Improve Diet Quality-MOSTDQ (Aim 1)
- ClinicalTrials.gov ID
- NCT04632212
- Acronym / sponsor ID
- MOH-000263
- Conditions
- Diet Quality
- Keywords
- Multi-component Intervention, Multi-phase Optimization Strategy, Tax, Food Labels, Quality based ordering, Within group substitutes, Full-factorial design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to use the Multiphase Optimization Strategy (MOST) to build and optimize a multi-component intervention that improves diet quality. The investigators will evaluate the effects of evidence-based public health interventions on consumers' diet quality via a web-based grocery store "NUSMart" and then identify a multi-component intervention that includes only those interventions meaningfully affecting diet quality.
Detailed 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 labeling, and behavioral nudges.
No study has previously assessed the potentially interactive effects of a multi-component 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.
To this end, the investigators chose a full-factorial design because this experimental design allows us to estimate not only the independent (main) effects of the interventions but also their interaction effects. The full-factorial design includes all possible combinations of the interventions' status. Because the investigators have four interventions, each of which has two levels (intervention On or Off), there are 16 (i.e. 2^4) experimental conditions/arms in total. The four interventions for this study are outlined below:
- Explicit Tax: To impose an explicit tax on food and beverage items that are eligible for red stop-sign (explained in b.) as less healthy foods.
Foods and Beverages: The investigators will impose a 20% tax on sales price of the food items.
- Food Labels (with the summary of healthiness of shopping baskets \& targets): To provide the green circle 'healthy choice' food label to items with Nutri-Score "A" and "B", the amber circle 'in between healthy and unhealthy choice' food label to items with Nutri-Score "C", and the red stop-sign 'Unhealthy choice' food label to items with Nutri-Score "D" and "E". In the presence of food labels, before shopping, subjects will watch a video briefly explaining the food labels on the store and be provided a live visual indicator of the healthiness of shoppers' current basket (called "My Cart Summary") with the recommended healthy baskets goals (i.e., Green logo products ≥ 60% and Red logo products ≤ 15% of the weighted number of servings of products.). My Cart Summary will be displayed as a pie chart with the proportion of servings in their current shopping baskets, according to the three food labels. This way, as shoppers add to their basket while browsing the store, they will have visual feedback on how their latest addition contributes to their total basket healthiness.
- Ordering: To order food items by Nutri-Score such that healthier items are shown upfront on NUSMart.
- Within Group Substitution: At the checkout, to provide consumers with an opportunity to replace their original items with an item chosen from two or four recommended substitutes that are healthier within their corresponding food categories based on the similarities of price, ingredients, flavor, and other characteristics.
Participants will be randomly assigned to one of the 16 arms and instructed to perform a one-time hypothetical grocery shopping on NUSMart.
The investigators will collect participants' demographic and health characteristics as well as hunger at the time of the survey and their self-control in the baseline survey. The collected data will be used to precisely estimate the causal effect of the interventions and address their underlying mechanism to change consumers' food choices.
Our hypotheses about the effects of the interventions on diet quality, measured by the weighted average Nutri-Score (primary) of finalized shopping baskets, are as follows:
- There will be significant and positive main effects of each of the interventions.
- There will be significant and positive interaction effects on diet quality of: Explicit tax \& food labels, Food labels \& ordering.
We will also 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 self-control, hunger, and health-status. To test the moderating effects of hunger, self-control, health-status, and education level, we will include interaction terms between the intervention arms and these variables.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Explicit Tax, Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets), Behavioral: Ordering, Behavioral: Within-Group SubstitutionTax (ON) Food Labels (ON) Ordering (ON) Substitution (ON) |
| 2 | Experimental | Behavioral: Explicit Tax, Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets), Behavioral: OrderingTax (ON) Food Labels (ON) Ordering (ON) Substitution (OFF) |
| 3 | Experimental | Behavioral: Explicit Tax, Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets), Behavioral: Within-Group SubstitutionTax (ON) Food Labels (ON) Ordering (OFF) Substitution (ON) |
| 4 | Experimental | Behavioral: Explicit Tax, Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets)Tax (ON) Food Labels (ON) Ordering (OFF) Substitution (OFF) |
| 5 | Experimental | Behavioral: Explicit Tax, Behavioral: Ordering, Behavioral: Within-Group SubstitutionTax (ON) Food Labels (OFF) Ordering (ON) Substitution (ON) |
| 6 | Experimental | Behavioral: Explicit Tax, Behavioral: OrderingTax (ON) Food Labels (OFF) Ordering (ON) Substitution (OFF) |
| 7 | Experimental | Behavioral: Explicit Tax, Behavioral: Within-Group SubstitutionTax (ON) Food Labels (OFF) Ordering (OFF) Substitution (ON) |
| 8 | Experimental | Behavioral: Explicit TaxTax (ON) Food Labels (OFF) Ordering (OFF) Substitution (OFF) |
| 9 | Experimental | Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets), Behavioral: Ordering, Behavioral: Within-Group SubstitutionTax (OFF) Food Labels (ON) Ordering (ON) Substitution (ON) |
| 10 | Experimental | Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets), Behavioral: OrderingTax (OFF) Food Labels (ON) Ordering (ON) Substitution (OFF) |
| 11 | Experimental | Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets), Behavioral: Within-Group SubstitutionTax (OFF) Food Labels (ON) Ordering (OFF) Substitution (ON) |
| 12 | Experimental | Behavioral: Food Labels (with the summary of healthiness of shopping baskets & targets)Tax (OFF) Food Labels (ON) Ordering (OFF) Substitution (OFF) |
| 13 | Experimental | Behavioral: Ordering, Behavioral: Within-Group SubstitutionTax (OFF) Food Labels (OFF) Ordering (ON) Substitution (ON) |
| 14 | Experimental | Behavioral: OrderingTax (OFF) Food Labels (OFF) Ordering (ON) Substitution (OFF) |
| 15 | Experimental | Behavioral: Within-Group SubstitutionTax (OFF) Food Labels (OFF) Ordering (OFF) Substitution (ON) |
| 16 | No intervention | –Tax (OFF) Food Labels (OFF) Ordering (OFF) Substitution (OFF) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singapore Resident
- Age 21 and above
- Must be the primary weekly grocery shopper in their household
Key exclusion criteria (3 listed)
- Non-Singapore resident
- Less than 21 years old
- Non-primary grocery shopper in their household
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explicit TaxTo impose an explicit tax on food and beverage items that are eligible for red stop-sign food logos (explained in Intervention 2) as less healthy foods. Explicit tax shows pre-tax prices and a label indicating that the price includes a corresponding tax on the less healthy products. Food and Beverages: we will impose a 20% tax on sales price of the food items | Behavioural | 1, 2, 3, 4, 5, 6, 7, 8 |
| Food Labels (with the summary of healthiness of shopping baskets & targets)To provide the green circle 'healthy choice' food label to items with Nutri-Score "A" and "B", the amber circle 'in between healthy and unhealthy choice' food label to items with Nutri-Score "C", and the red stop-sign 'less healthy choice' food label to items with Nutri-Score "D" and "E". In the presence of food labels, * Video: subjects will watch a video briefly explaining the food labels on the store. * My Cart Summary: subjects will be provided a live visual indicator of the healthiness of shoppers' current basket with the recommended healthy baskets goals. | Behavioural | 1, 10, 11, 12, 2, 3, 4, 9 |
| OrderingTo order food items by Nutri-Score (high to low). | Behavioural | 1, 10, 13, 14, 2, 5, 6, 9 |
| Within-Group SubstitutionTo provide substitutes within corresponding food categories that are better than the items that subjects chose in terms of Nutri-Score based on the similarities of price, primary ingredients, flavor, and other characteristics. | Behavioural | 1, 11, 13, 15, 3, 5, 7, 9 |
Primary outcome
Diet Quality
Time frame: At the end of data collection, up to 8 weeks
Diet quality measured by the weighted average of all purchased products' Nutri-Score for the shopping trip. Nutri-Score is an individual dietary index based on the British Food Standard Agency Nutrient Profiling System.
2 secondary outcomes
Proportion of products
Time frame: At the end of data collection, up to 8 weeks
Average nutrients per serving
Time frame: At the end of data collection, up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 35195704Shin S, Chakraborty B, Yan X, van Dam RM, Finkelstein EA. Evaluation of Combinations of Nudging, Pricing, and Labeling Strategies to Improve Diet Quality: A Virtual Grocery Store Experiment Employing a Multiphase Optimization Strategy. Ann Behav Med. 2022 Aug 30;56(9):933-945. doi: 10.1093/abm/kaab115.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explicit Tax, Food Labels (with the summary of healthiness of shopping baskets & targets) and Ordering in people with Diet Quality, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Quality (time frame: At the end of data collection, up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632212, which also lists 1 linked publication.
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 4 Feb 2021.