Nonalcoholic Fatty Liver DiseaseNCT04186793
Comparison of Dietary Sugar Reduction Methods
A study testing Guided Grocery Shopping (GGS) and Diet Provision Group in people with Nonalcoholic Fatty Liver Disease, run by Emory University at 2 sites in United States.
Trial summary
This is a two arm, randomized, 4 week study comparing 2 methods of dietary sugar reduction at Emory University and Children's Healthcare of Atlanta. Participants will be non-diabetic children with NAFLD. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- Guided Grocery Shopping (GGS) and Diet Provision Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Feb 2020to 15 Dec 2021
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical history consistent with NAFLD
- Written informed consent from parent or legal guardian
- Written or verbal informed assent from the child
- Currently regularly consumes sugary beverages ( ≥ 2 eight ounce sugar drinks or juice per week)
Who cannot join
- Participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigators
- History of significant depression
- Diabetes
- Evidence of other chronic liver disease
- Children who are currently enrolled in a clinical trial or who received an investigational study drug or dietary intervention within the past 60 days
- Participants who are not able or willing to comply with the diet protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator
- Families with > 6 individuals
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Altanta
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
About this study
This is a two arm, randomized, 4 week study comparing 2 methods of dietary sugar reduction at Emory University and Children's Healthcare of Atlanta. Participants will be non-diabetic children with NAFLD. Two groups of 6 participants will be followed for 4 weeks during the randomized controlled trial followed by a 20 week follow-up extension. One group will receive a guided grocery shopping (GGS) intervention for 4 weeks while the other group will be provided with a low free sugars (<3% total daily) diet.
The goal of this study is to determine if guided grocery shopping (GGS) over 4 weeks is equivalent to complete family diet provision in reducing free sugar intake to <3% of total energy (TE) and if GGS will sustain the dietary change over 6 months.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) is a condition in which abnormal amounts of fat deposit in the liver. This ectopic deposition of triglycerides is metabolically harmful to the liver and is strongly associated with dysregulation of lipid metabolism and insulin resistance. NAFLD is increasing in prevalence in children and now is estimated to affect ~30% of obese children in the U.S. and 6-15% of children across the world. The severity of the disease ranges widely, from mild with increased fat (steatosis) alone to more severe phenotypes of steatosis, inflammation and hepatocyte ballooning (called steatohepatitis) to cirrhosis. While the natural course of pediatric NAFLD is not fully understood, in adults, progression to cirrhosis occurs in about 10%. Diabetes is strongly associated with NAFLD and in children the incidence of prediabetes and diabetes in children with NAFLD is 3 to 5% per year, markedly increases from population estimates of 3.5/cases per 100,000.
Because of the high prevalence of NAFLD, especially among children with obesity, and the increased mortality and morbidity associated with NAFLD, it has become a focus for therapeutic development. In children, there have been several phase 2 clinical trials, but to date there no approved medications for NAFLD. The current standard of care for pediatric NAFLD treatment is healthy diet and exercise. Which "healthy diet" to apply is unknown. Short term evidence in adults supports a variety of approaches including Mediterranean diet, low-fat diet, and low-carbohydrate diet.
For children, there has been a focus on diet quality rather than weight loss. In totality, research demonstrates that consumption of free sugars leads to increased triglycerides, decreased high density lipoprotein cholesterol (HDLc) and increased very low density lipoprotein (VLDL) size, as well as endotoxemia, while reduction of free sugars improves hepatic fat and inflammation.
Complete diet provision is established as an effective research tool to test a diet modification. However, this approach becomes impractical, unsustainable, and expensive when applied across a large multicenter trial. Consequently, less intensive methods would be highly beneficial, if they are equally effective in modifying the diet. Thus, this randomized equivalence pilot study has been designed to test if facilitated grocery shopping will be equivalent to complete diet provision in reducing free sugar consumption to ≤ 3% in children with NAFLD.
This is a 4-week randomized, controlled, outpatient feeding study at Emory University and Children's Healthcare of Atlanta. Participants will be non-diabetic children with NAFLD. Two groups of 6 participants will be followed for 24 weeks. This will include 4 weeks during which the randomized controlled trial will be conducted, followed by a 20 week follow-up. One group will receive the guided grocery shopping (GGS) intervention for 4 weeks while the other group will be provided with a low free sugars (goal of <3% total daily calories) version of their family's habitual diets. Both groups will receive diet/nutrition counseling and support once per week during the intervention period.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- Guided Grocery Shopping (GGS), Diet Provision Group
- Keywords
- Pediatrics, Obesity, Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Grocery Shopping (GGS)Behavioural
The GGS group will be scheduled for 4 weekly sessions to co-shop with the study Registered Dietitian (RD) or clinical research coordinator (CRC). The primary shopper for the household will be required to attend all 4 sessions. The study participant will be required to attend at least 1 session and other family/household members will be encouraged to attend. The weekly sessions will take place at the family's primary grocery store. During each session, the RD will facilitate selection of low free sugar foods and guide the primary shopper on menu planning for a low free sugar diet. In the 4th session, the primary shopper will be asked to shop independently while being observed by the RD/CRC. Prior to checking out, the RD/CRC will approve and/or correct their shopping choices.
During the follow-up period, all participants will receive diet counseling/support calls from the dietitian and/or research team at Months 2, 4, and 6, following intervention completion.
Diet Provision GroupOther
This intervention will be applied to each family and will target foods and beverages that contain free sugars added to food by consumer, cook, or manufacturer, but preserve the family's other food group choices. During the 4 week long intervention, families will be able to choose meals from a list of foods similar to their usual diet. Groceries for each week will be delivered to the family. Each child will be provided with a lunch bag and instructed to bring lunch to school to maintain the study diet.
Families will have the opportunity to choose from a list of pre-prepared evening meals that are similar to what they consumed before study initiation but without free sugars. The families will be instructed to not eat any food outside of the assigned diet.
During the follow-up period, all participants will receive diet counseling/support calls from the dietitian and/or research team at Months 2, 4, and 6, following intervention completion.
| Study group | Role | What they receive |
|---|---|---|
| Guided Grocery Shopping | Experimental | Participants in this study arm will receive a guided grocery shopping intervention for four weeks. Receives: Behavioral: Guided Grocery Shopping (GGS) |
| Diet Provision Group | Experimental | Participants in this study arm will be provided with a diet low in free sugars. This intervention replaces the habitual diet with a low "free sugars" diet (goal of <3% of total calories). Receives: Other: Diet Provision Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent of Calories from Free Sugars
The percent of calories from free sugars in the GGS group will be compared to the diet provision group. Participants will complete a dietary recall covering three 24-hour periods.
Measured: Baseline, Week 4, Week 24
Secondary outcomes (2)
Diet compliance
Perception of diet compliance difficulty will be assessed qualitatively. Semi-structured interviews will be performed with the participant and their parent/guardian at the end of the study to ascertain their experience during the intervention
Measured: Week 4, Week 24
Ability to Sustain Diet
Perception of the ability to sustain the diet will be assessed qualitatively. Semi-structured interviews will be performed with the participant and their parent/guardian at the end of the study to assess their ability to achieve and maintain a low sugar diet.
Measured: Week 4, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start6 Feb 2020
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cystic Fibrosis and Airways Disease Research
- Responsible party
- Principal investigator, Miriam Vos, Emory University
- Investigators
- Miriam Vos, MD, MSPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186793
- Sponsor's protocol ID
- IRB00115167
- Status last verified
- Mar 2022
- First submitted
- 3 Dec 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dietary Sugar Reduction Methods
- ClinicalTrials.gov ID
- NCT04186793
- Acronym / sponsor ID
- IRB00115167
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- Pediatrics, Obesity, Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Center for Cystic Fibrosis and Airways Disease Research
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 5 Dec 2019 (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 two arm, randomized, 4 week study comparing 2 methods of dietary sugar reduction at Emory University and Children's Healthcare of Atlanta. Participants will be non-diabetic children with NAFLD. Two groups of 6 participants will be followed for 4 weeks during the randomized controlled trial followed by a 20 week follow-up extension. One group will receive a guided grocery shopping (GGS) intervention for 4 weeks while the other group will be provided with a low free sugars (<3% total daily) diet.
The goal of this study is to determine if guided grocery shopping (GGS) over 4 weeks is equivalent to complete family diet provision in reducing free sugar intake to <3% of total energy (TE) and if GGS will sustain the dietary change over 6 months.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is a condition in which abnormal amounts of fat deposit in the liver. This ectopic deposition of triglycerides is metabolically harmful to the liver and is strongly associated with dysregulation of lipid metabolism and insulin resistance. NAFLD is increasing in prevalence in children and now is estimated to affect ~30% of obese children in the U.S. and 6-15% of children across the world. The severity of the disease ranges widely, from mild with increased fat (steatosis) alone to more severe phenotypes of steatosis, inflammation and hepatocyte ballooning (called steatohepatitis) to cirrhosis. While the natural course of pediatric NAFLD is not fully understood, in adults, progression to cirrhosis occurs in about 10%. Diabetes is strongly associated with NAFLD and in children the incidence of prediabetes and diabetes in children with NAFLD is 3 to 5% per year, markedly increases from population estimates of 3.5/cases per 100,000.
Because of the high prevalence of NAFLD, especially among children with obesity, and the increased mortality and morbidity associated with NAFLD, it has become a focus for therapeutic development. In children, there have been several phase 2 clinical trials, but to date there no approved medications for NAFLD. The current standard of care for pediatric NAFLD treatment is healthy diet and exercise. Which "healthy diet" to apply is unknown. Short term evidence in adults supports a variety of approaches including Mediterranean diet, low-fat diet, and low-carbohydrate diet.
For children, there has been a focus on diet quality rather than weight loss. In totality, research demonstrates that consumption of free sugars leads to increased triglycerides, decreased high density lipoprotein cholesterol (HDLc) and increased very low density lipoprotein (VLDL) size, as well as endotoxemia, while reduction of free sugars improves hepatic fat and inflammation.
Complete diet provision is established as an effective research tool to test a diet modification. However, this approach becomes impractical, unsustainable, and expensive when applied across a large multicenter trial. Consequently, less intensive methods would be highly beneficial, if they are equally effective in modifying the diet. Thus, this randomized equivalence pilot study has been designed to test if facilitated grocery shopping will be equivalent to complete diet provision in reducing free sugar consumption to ≤ 3% in children with NAFLD.
This is a 4-week randomized, controlled, outpatient feeding study at Emory University and Children's Healthcare of Atlanta. Participants will be non-diabetic children with NAFLD. Two groups of 6 participants will be followed for 24 weeks. This will include 4 weeks during which the randomized controlled trial will be conducted, followed by a 20 week follow-up. One group will receive the guided grocery shopping (GGS) intervention for 4 weeks while the other group will be provided with a low free sugars (goal of <3% total daily calories) version of their family's habitual diets. Both groups will receive diet/nutrition counseling and support once per week during the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Grocery Shopping | Experimental | Behavioral: Guided Grocery Shopping (GGS)Participants in this study arm will receive a guided grocery shopping intervention for four weeks. |
| Diet Provision Group | Experimental | Other: Diet Provision GroupParticipants in this study arm will be provided with a diet low in free sugars. This intervention replaces the habitual diet with a low "free sugars" diet (goal of <3% of total calories). |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical history consistent with NAFLD
- Written informed consent from parent or legal guardian
- Written or verbal informed assent from the child
- Currently regularly consumes sugary beverages ( ≥ 2 eight ounce sugar drinks or juice per week)
Key exclusion criteria (7 listed)
- Participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigators
- History of significant depression
- Diabetes
- Evidence of other chronic liver disease
- Children who are currently enrolled in a clinical trial or who received an investigational study drug or dietary intervention within the past 60 days
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 |
|---|---|---|
| Guided Grocery Shopping (GGS)The GGS group will be scheduled for 4 weekly sessions to co-shop with the study Registered Dietitian (RD) or clinical research coordinator (CRC). The primary shopper for the household will be required to attend all 4 sessions. The study participant will be required to attend at least 1 session and other family/household members will be encouraged to attend. The weekly sessions will take place at the family's primary grocery store. During each session, the RD will facilitate selection of low free sugar foods and guide the primary shopper on menu planning for a low free sugar diet. In the 4th session, the primary shopper will be asked to shop independently while being observed by the RD/CRC. Prior to checking out, the RD/CRC will approve and/or correct their shopping choices. During the follow-up period, all participants will receive diet counseling/support calls from the dietitian and/or research team at Months 2, 4, and 6, following intervention completion. | Behavioural | Guided Grocery Shopping |
| Diet Provision GroupThis intervention will be applied to each family and will target foods and beverages that contain free sugars added to food by consumer, cook, or manufacturer, but preserve the family's other food group choices. During the 4 week long intervention, families will be able to choose meals from a list of foods similar to their usual diet. Groceries for each week will be delivered to the family. Each child will be provided with a lunch bag and instructed to bring lunch to school to maintain the study diet. Families will have the opportunity to choose from a list of pre-prepared evening meals that are similar to what they consumed before study initiation but without free sugars. The families will be instructed to not eat any food outside of the assigned diet. During the follow-up period, all participants will receive diet counseling/support calls from the dietitian and/or research team at Months 2, 4, and 6, following intervention completion. | Other | Diet Provision Group |
Primary outcome
Change in Percent of Calories from Free Sugars
Time frame: Baseline, Week 4, Week 24
The percent of calories from free sugars in the GGS group will be compared to the diet provision group. Participants will complete a dietary recall covering three 24-hour periods.
2 secondary outcomes
Diet compliance
Time frame: Week 4, Week 24
Ability to Sustain Diet
Time frame: Week 4, Week 24
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 25 Mar 2022.
- 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.
Miriam Vos, MD, MSPH principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Grocery Shopping (GGS) and Diet Provision Group in people with Nonalcoholic Fatty Liver Disease, run by Emory University at 2 sites 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 4 inclusion and 7 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Percent of Calories from Free Sugars (time frame: Baseline, Week 4, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2022.