Comparison of Dietary Sugar Reduction Methods
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

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. 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.
    

Intervention name(s): Guided Grocery Shopping (GGS); Diet Provision Group
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatrics; Obesity; Liver Disease