Comparison of Dietary Sugar Reduction Methods

NCT04186793 | Completed

• 1 other identifier: IRB00115167
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Pediatrics; Obesity; Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 4, Week 24

Secondary Outcomes (2)

• Diet compliance

  Week 4, Week 24

• Ability to Sustain Diet

  Week 4, Week 24

Study Arms (2)

Guided Grocery Shopping

EXPERIMENTAL

Participants in this study arm will receive a guided grocery shopping intervention for four weeks.

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).

Other: Diet Provision Group

Interventions

Guided Grocery Shopping (GGS) BEHAVIORAL

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.

Guided Grocery Shopping

Diet Provision Group OTHER

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.

Diet Provision Group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Center for Cystic Fibrosis and Airways Disease Research: collaborator

Study Sites (2)

Children's Healthcare of Altanta

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Liver Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miriam Vos, MD, MSPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: February 6, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)