Comparison of Dietary Sugar Reduction Methods

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.

Conditions

• Nonalcoholic Fatty Liver Disease

Interventions

BEHAVIORAL

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.

OTHER

Diet Provision Group

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.

Sponsors & Collaborators

• Center for Cystic Fibrosis and Airways Disease Research

  collaborator UNKNOWN

• Emory University

  lead OTHER

Principal Investigators

• Miriam Vos, MD, MSPH · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-06

Primary Completion

2021-12-15

Completion

2021-12-15

Countries

• United States

Study Locations