Food InsecurityNCT04986046
Fruit and Vegetable Rx (FVRx) + Home Plate
A study testing Home Plate Lite, Home Plate and Fruit and Vegetable prescription in people with Food Insecurity, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This is a research study to test if fruit and vegetable prescription vouchers (FVRx) and a cooking skills program (Home Plate) can improve dietary quality, food security (access to a sufficient quantity of affordable, nutritious food), feelings about the home and community food environments, and caregiver mental… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Home Plate Lite, Home Plate and Fruit and Vegetable prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 3 Apr 2024
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one child in the household is age 2 to 5 years.
- Household is food insecure and/or low-income with an age-eligible, overweight or obese child.
- If a child meets the above criteria, any sibling age 2-5 is also eligible.
Who cannot join
- 1. Caregiver or eligible children have a medical condition that significantly affects diet or eating habits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Fruit and Vegetable Rx + Home Plate, a Multilevel Intervention to Improve Dietary Disparities Among Low-income Children and Families
This is a research study to test if fruit and vegetable prescription vouchers (FVRx) and a cooking skills program (Home Plate) can improve dietary quality, food security (access to a sufficient quantity of affordable, nutritious food), feelings about the home and community food environments, and caregiver mental health.
Read the detailed description
The purpose of this research study is to determine the effect of produce prescriptions (vouchers that can be redeemed for produce at participating locations, "FVRx") and a cooking skills program (Home Plate) on dietary quality, food security, perceptions of the food environment, and mental health. Investigators also aim to determine the feasibility and acceptability of the programs.
- Conditions
- Food Insecurity
- Being tested
- Home Plate Lite, Home Plate, Fruit and Vegetable prescription
- Keywords
- Diet quality, Cooking, Food security, Food access, Community food environment, Mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Plate LiteOther
Home Plate Lite comprises electronic educational content (e.g. recipes, instructional videos) disbursed at least weekly over six weeks.
Home PlateOther
Home Plate comprises six 1.5-hour weekly sessions where parents work together with a study staff member to discuss the learning objectives and prepare the components of a meal, including entrees, side dishes, and desserts.
Fruit and Vegetable prescriptionOther
All families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia
| Study group | Role | What they receive |
|---|---|---|
| Fruit and vegetable prescription | Active comparator | Fruit and vegetable incentive program Receives: Other: Fruit and Vegetable prescription |
| Fruit and vegetable prescription + Home Plate Lite | Experimental | Fruit and vegetable incentive program + asynchronous, electronic resources delivered over six weeks (Home Plate Lite) Receives: Other: Home Plate Lite; Other: Fruit and Vegetable prescription |
| Fruit and vegetable prescription + Home Plate | Experimental | Fruit and vegetable incentive program + 1.5-hour, virtual, small-group classes weekly for six weeks (Home Plate) Receives: Other: Home Plate; Other: Fruit and Vegetable prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diet quality
Diet quality of the child will be measured by use of an automated self-administered 24-hour dietary recall system (ASA24), completed by the child's caregiver. The ASA24 is a web-based tool that enables automatically coded, self-administered 24-hour diet recalls, providing high-quality dietary data. The ASA24 system is adapted from the United States Department of Agriculture (USDA) Automated Multiple-Pass Method, which has been validated. Validation and evaluation studies of ASA24 have found close agreement with standardized interview-administered 24 hour recall.
Measured: baseline and 8 weeks
Secondary outcomes (11)
Change in Food security - Food Security Survey
Food security status will be assessed using the USDA Food Security Survey. The 18-item USDA Food Security Survey the time period (e.g. last 30 days) and specify lack of resources as the reason for the behavior or experience (e.g. "couldn't afford more food," or "there was not enough money for food") to determine the level food security (very low, low, marginal, and full). Participants are asked to check boxes next to statements that best describe their behavior. These surveys will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the intervention.
Measured: baseline and 8 weeks
Change in Food security - Hunger Coping Scale
Food security status will be assessed using the Hunger Coping Scale. The five items from the Hunger Coping Scale question the time period (e.g. last 30 days) and specify lack of resources as the reason for the behavior or experience (e.g. "couldn't afford more food," or "there was not enough money for food") to determine the level food security (very low, low, marginal, and full). Participants are asked to check boxes next to statements that best describe their behavior. These surveys will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the intervention.
Measured: baseline and 8 weeks
Change in Food security - 2-item Nutrition Security Screener (NSS)
Food security status will be assessed using the NSS. These surveys will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the intervention.
Measured: baseline and 8 weeks
Change in Caregiver diet quality
Caregiver diet quality will be measured by the caregivers completion of the automated self-administered 24-hour dietary recall system (ASA24) for themselves at baseline and 8 weeks following the initiation of the nutrition education intervention. The ASA24, is a web-based tool that enables automatically coded, self-administered 24-hour diet recalls, providing high-quality dietary data. The ASA24 system is adapted from the USDA Automated Multiple-Pass Method, which has been validated.
Measured: baseline and 8 weeks
Change in Caregiver perceived food environment
Perceptions of food environment will be assessed using the Perceived Nutrition Environment Measures survey (NEMS-P). The survey is completed by the person who does the majority of the food shopping in a household to learn about his/her perceptions of the nutrition environments (where food is consumed or purchased, and in the home). Participants are asked to check boxes next to statements that best describe their behavior (e.g. "strongly disagree" to "strongly agree" or "never or rarely" to "almost always". Components within the survey ar examined individually. The survey can discriminate perceptions of nutrition environments between residents of higher- and lower-socioeconomic status (SES) neighborhoods. The NEMS-P will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the nutrition education intervention.
Measured: baseline and 8 weeks
Change in Caregiver mental health - Loneliness
Caregiver mental health will be measured using the Revised UCLA (R-UCLA) Loneliness Scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item on a scale from "hardly ever" to "often". Minimum score is 3 maximum score is 9; higher scores indicate worse outcome.
Measured: baseline and 8 weeks
Program feasibility - Voucher Redemption
Program feasibility will be assessed through voucher redemption
Measured: 8 weeks
Program feasibility - Home Plate Class Attendance
Program feasibility will be assessed through virtual Home Plate class attendance
Measured: 8 weeks
Program feasibility - Participant Satisfaction
Program feasibility will be assessed through participant feedback measured by completion of the participant satisfaction surveys and phone interviews post intervention.
Measured: 8 weeks
Change in Urine Metabolites
Urine samples will be collected from subjects at baseline and 8 weeks and measured by metabolomic analysis to quantify association with dietary biomarkers.
Measured: Baseline and 8 weeks
Change in Caregiver mental health - Depression
The Center for Epidemiologic Studies Depressive Scale (CES-D) is a 20-item questionnaire that includes a brief self-report for which the scale is designed to measure self-reported symptoms associated with depression experienced in the past week. Participants rate each item on a scale from 0= "Rarely or none of the time (less than 1-day)", 1= "Some or a little of the time (1-2 days)," 2= "Occasionally or a moderate amount of the time (3-4 days," or 3="Most or all of the time (5-7 days)."The scale will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the interventions. High scores indicating greater depressive symptoms.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Jan 2022
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- McClay Foundation, University of Pennsylvania, The Leo and Peggy Pierce Family Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986046
- Sponsor's protocol ID
- 20-018132
- Status last verified
- Feb 2025
- First submitted
- 9 Jun 2021
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith LP, Ng SW, Popkin BM. Trends in US home food preparation and consumption: analysis of national nutrition surveys and time use studies from 1965-1966 to 2007-2008. Nutr J. 2013 Apr 11;12:45. doi: 10.1186/1475-2891-12-45.
PubMed 23577692Zick CD, Stevens RB. Trends in Americans' food-related time use: 1975-2006. Public Health Nutr. 2010 Jul;13(7):1064-72. doi: 10.1017/S1368980009992138. Epub 2009 Nov 30.
PubMed 19943999Brownell KD. Fast food and obesity in children. Pediatrics. 2004 Jan;113(1 Pt 1):132. doi: 10.1542/peds.113.1.132. No abstract available.
PubMed 14702462Nelson SA, Corbin MA, Nickols-Richardson SM. A call for culinary skills education in childhood obesity-prevention interventions: current status and peer influences. J Acad Nutr Diet. 2013 Aug;113(8):1031-6. doi: 10.1016/j.jand.2013.05.002. No abstract available.
PubMed 23885701Kim SA, Moore LV, Galuska D, Wright AP, Harris D, Grummer-Strawn LM, Merlo CL, Nihiser AJ, Rhodes DG; Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion, CDC. Vital signs: fruit and vegetable intake among children - United States, 2003-2010. MMWR Morb Mortal Wkly Rep. 2014 Aug 8;63(31):671-6.
PubMed 25102415Moore LV, Thompson FE. Adults Meeting Fruit and Vegetable Intake Recommendations - United States, 2013. MMWR Morb Mortal Wkly Rep. 2015 Jul 10;64(26):709-13.
PubMed 26158351Jun S, Thuppal SV, Maulding MK, Eicher-Miller HA, Savaiano DA, Bailey RL. Poor Dietary Guidelines Compliance among Low-Income Women Eligible for Supplemental Nutrition Assistance Program-Education (SNAP-Ed). Nutrients. 2018 Mar 8;10(3):327. doi: 10.3390/nu10030327.
PubMed 29518042Rivera RL, Maulding MK, Eicher-Miller HA. Effect of Supplemental Nutrition Assistance Program-Education (SNAP-Ed) on food security and dietary outcomes. Nutr Rev. 2019 Dec 1;77(12):903-921. doi: 10.1093/nutrit/nuz013.
PubMed 31077323Whiteman ED, Chrisinger BW, Hillier A. Diet Quality Over the Monthly Supplemental Nutrition Assistance Program Cycle. Am J Prev Med. 2018 Aug;55(2):205-212. doi: 10.1016/j.amepre.2018.04.027. Epub 2018 Jun 21.
PubMed 29935945Block JP, Subramanian SV. Moving Beyond "Food Deserts": Reorienting United States Policies to Reduce Disparities in Diet Quality. PLoS Med. 2015 Dec 8;12(12):e1001914. doi: 10.1371/journal.pmed.1001914. eCollection 2015 Dec.
PubMed 26645285Choi SE, Seligman H, Basu S. Cost Effectiveness of Subsidizing Fruit and Vegetable Purchases Through the Supplemental Nutrition Assistance Program. Am J Prev Med. 2017 May;52(5):e147-e155. doi: 10.1016/j.amepre.2016.12.013. Epub 2017 Jan 30.
PubMed 28153648Cohen AJ, Richardson CR, Heisler M, Sen A, Murphy EC, Hesterman OB, Davis MM, Zick SM. Increasing Use of a Healthy Food Incentive: A Waiting Room Intervention Among Low-Income Patients. Am J Prev Med. 2017 Feb;52(2):154-162. doi: 10.1016/j.amepre.2016.11.008.
PubMed 28109458Olsho LE, Klerman JA, Wilde PE, Bartlett S. Financial incentives increase fruit and vegetable intake among Supplemental Nutrition Assistance Program participants: a randomized controlled trial of the USDA Healthy Incentives Pilot. Am J Clin Nutr. 2016 Aug;104(2):423-35. doi: 10.3945/ajcn.115.129320. Epub 2016 Jun 22.
PubMed 27334234Young CR, Aquilante JL, Solomon S, Colby L, Kawinzi MA, Uy N, Mallya G. Improving fruit and vegetable consumption among low-income customers at farmers markets: Philly Food Bucks, Philadelphia, Pennsylvania, 2011. Prev Chronic Dis. 2013 Oct 3;10:E166. doi: 10.5888/pcd10.120356.
PubMed 24135390Tester JM, Leung CW, Crawford PB. Revised WIC Food Package and Children's Diet Quality. Pediatrics. 2016 May;137(5):e20153557. doi: 10.1542/peds.2015-3557. Epub 2016 Apr 7.
PubMed 27244804
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruit and Vegetable Rx + Home Plate, a Multilevel Intervention to Improve Dietary Disparities Among Low-income Children and Families
- ClinicalTrials.gov ID
- NCT04986046
- Acronym / sponsor ID
- 20-018132
- Conditions
- Food Insecurity
- Keywords
- Diet quality, Cooking, Food security, Food access, Community food environment, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- McClay Foundation, University of Pennsylvania, The Leo and Peggy Pierce Family Foundation
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 2 Aug 2021 (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 is a research study to test if fruit and vegetable prescription vouchers (FVRx) and a cooking skills program (Home Plate) can improve dietary quality, food security (access to a sufficient quantity of affordable, nutritious food), feelings about the home and community food environments, and caregiver mental health.
Detailed description
The purpose of this research study is to determine the effect of produce prescriptions (vouchers that can be redeemed for produce at participating locations, "FVRx") and a cooking skills program (Home Plate) on dietary quality, food security, perceptions of the food environment, and mental health. Investigators also aim to determine the feasibility and acceptability of the programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fruit and vegetable prescription | Active comparator | Other: Fruit and Vegetable prescriptionFruit and vegetable incentive program |
| Fruit and vegetable prescription + Home Plate Lite | Experimental | Other: Home Plate Lite, Other: Fruit and Vegetable prescriptionFruit and vegetable incentive program + asynchronous, electronic resources delivered over six weeks (Home Plate Lite) |
| Fruit and vegetable prescription + Home Plate | Experimental | Other: Home Plate, Other: Fruit and Vegetable prescriptionFruit and vegetable incentive program + 1.5-hour, virtual, small-group classes weekly for six weeks (Home Plate) |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- At least one child in the household is age 2 to 5 years.
- Household is food insecure and/or low-income with an age-eligible, overweight or obese child.
Key exclusion criteria (1 listed)
- 1. Caregiver or eligible children have a medical condition that significantly affects diet or eating habits.
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 |
|---|---|---|
| Home Plate LiteHome Plate Lite comprises electronic educational content (e.g. recipes, instructional videos) disbursed at least weekly over six weeks. | Other | Fruit and vegetable prescription + Home Plate Lite |
| Home PlateHome Plate comprises six 1.5-hour weekly sessions where parents work together with a study staff member to discuss the learning objectives and prepare the components of a meal, including entrees, side dishes, and desserts. | Other | Fruit and vegetable prescription + Home Plate |
| Fruit and Vegetable prescriptionAll families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia | Other | Fruit and vegetable prescription, Fruit and vegetable prescription + Home Plate, Fruit and vegetable prescription + Home Plate Lite |
Primary outcome
Change in Diet quality
Time frame: baseline and 8 weeks
Diet quality of the child will be measured by use of an automated self-administered 24-hour dietary recall system (ASA24), completed by the child's caregiver. The ASA24 is a web-based tool that enables automatically coded, self-administered 24-hour diet recalls, providing high-quality dietary data. The ASA24 system is adapted from the United States Department of Agriculture (USDA) Automated Multiple-Pass Method, which has been validated. Validation and evaluation studies of ASA24 have found close agreement with standardized interview-administered 24 hour recall.
11 secondary outcomes
Change in Food security - Food Security Survey
Time frame: baseline and 8 weeks
Change in Food security - Hunger Coping Scale
Time frame: baseline and 8 weeks
Change in Food security - 2-item Nutrition Security Screener (NSS)
Time frame: baseline and 8 weeks
Change in Caregiver diet quality
Time frame: baseline and 8 weeks
Change in Caregiver perceived food environment
Time frame: baseline and 8 weeks
Change in Caregiver mental health - Loneliness
Time frame: baseline and 8 weeks
Program feasibility - Voucher Redemption
Time frame: 8 weeks
Program feasibility - Home Plate Class Attendance
Time frame: 8 weeks
Program feasibility - Participant Satisfaction
Time frame: 8 weeks
Change in Urine Metabolites
Time frame: Baseline and 8 weeks
Change in Caregiver mental health - Depression
Time frame: baseline and 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 19 Feb 2025.
- Background: PubMed 23577692Smith LP, Ng SW, Popkin BM. Trends in US home food preparation and consumption: analysis of national nutrition surveys and time use studies from 1965-1966 to 2007-2008. Nutr J. 2013 Apr 11;12:45. doi: 10.1186/1475-2891-12-45.
- Background: PubMed 19943999Zick CD, Stevens RB. Trends in Americans' food-related time use: 1975-2006. Public Health Nutr. 2010 Jul;13(7):1064-72. doi: 10.1017/S1368980009992138. Epub 2009 Nov 30.
- Background: PubMed 14702462Brownell KD. Fast food and obesity in children. Pediatrics. 2004 Jan;113(1 Pt 1):132. doi: 10.1542/peds.113.1.132. No abstract available.
- Background: PubMed 23885701Nelson SA, Corbin MA, Nickols-Richardson SM. A call for culinary skills education in childhood obesity-prevention interventions: current status and peer influences. J Acad Nutr Diet. 2013 Aug;113(8):1031-6. doi: 10.1016/j.jand.2013.05.002. No abstract available.
- Background: PubMed 25102415Kim SA, Moore LV, Galuska D, Wright AP, Harris D, Grummer-Strawn LM, Merlo CL, Nihiser AJ, Rhodes DG; Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion, CDC. Vital signs: fruit and vegetable intake among children - United States, 2003-2010. MMWR Morb Mortal Wkly Rep. 2014 Aug 8;63(31):671-6.
- Background: PubMed 26158351Moore LV, Thompson FE. Adults Meeting Fruit and Vegetable Intake Recommendations - United States, 2013. MMWR Morb Mortal Wkly Rep. 2015 Jul 10;64(26):709-13.
- Background: PubMed 29518042Jun S, Thuppal SV, Maulding MK, Eicher-Miller HA, Savaiano DA, Bailey RL. Poor Dietary Guidelines Compliance among Low-Income Women Eligible for Supplemental Nutrition Assistance Program-Education (SNAP-Ed). Nutrients. 2018 Mar 8;10(3):327. doi: 10.3390/nu10030327.
- Background: PubMed 31077323Rivera RL, Maulding MK, Eicher-Miller HA. Effect of Supplemental Nutrition Assistance Program-Education (SNAP-Ed) on food security and dietary outcomes. Nutr Rev. 2019 Dec 1;77(12):903-921. doi: 10.1093/nutrit/nuz013.
- Background: PubMed 29935945Whiteman ED, Chrisinger BW, Hillier A. Diet Quality Over the Monthly Supplemental Nutrition Assistance Program Cycle. Am J Prev Med. 2018 Aug;55(2):205-212. doi: 10.1016/j.amepre.2018.04.027. Epub 2018 Jun 21.
- Background: PubMed 26645285Block JP, Subramanian SV. Moving Beyond "Food Deserts": Reorienting United States Policies to Reduce Disparities in Diet Quality. PLoS Med. 2015 Dec 8;12(12):e1001914. doi: 10.1371/journal.pmed.1001914. eCollection 2015 Dec.
- Background: PubMed 28153648Choi SE, Seligman H, Basu S. Cost Effectiveness of Subsidizing Fruit and Vegetable Purchases Through the Supplemental Nutrition Assistance Program. Am J Prev Med. 2017 May;52(5):e147-e155. doi: 10.1016/j.amepre.2016.12.013. Epub 2017 Jan 30.
- Background: PubMed 28109458Cohen AJ, Richardson CR, Heisler M, Sen A, Murphy EC, Hesterman OB, Davis MM, Zick SM. Increasing Use of a Healthy Food Incentive: A Waiting Room Intervention Among Low-Income Patients. Am J Prev Med. 2017 Feb;52(2):154-162. doi: 10.1016/j.amepre.2016.11.008.
- 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 Home Plate Lite, Home Plate and Fruit and Vegetable prescription in people with Food Insecurity, run by Children's Hospital of Philadelphia at 1 site in United States.
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 1 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 19 Feb 2025. 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 United States. 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?
Change in Diet quality (time frame: baseline and 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 NCT04986046, which also lists 30 linked publications.
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 19 Feb 2025.