Childhood Obesity Microbiome Study

NCT04770311 | Completed

• 1 other identifier: Pro00107438
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the effectiveness of a microbiome diet using direct food provision on dietary quality and microbiome composition among children with obesity. This study proposes a pilot randomized, controlled clinical trial in children of a dietary intervention informed by microbiome science.

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (1)

• Change in child dietary quality as measured by the DSQ

  The investigators will use the DSQ, which is the 26-item Dietary Screener Questionnaire, that asks about the frequency of consumption in the past month of selected foods and drinks. The DSQ captures intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat. The study team will be focusing on microbiome friendly food, such as whole grains a fiber rich foods.

  Baseline, week 4 and week 8

Study Arms (2)

Control

NO INTERVENTION

In a typical Healthy Lifestyless Nutrition visit, dietitians provide medical nutrition therapy to patients and their families. This includes addressing abnormal, nutrition-related lab values and providing targeted nutrition advice (foods to include, foods to limit) in order to resolve said labs. Motivational interviewing techniques will be used to help families identify barriers to Lifestyles change and provide strategies to help overcome these barriers. Families will receive compensation per each nutritional visit.

Intervention

OTHER

Besides the usual standard of care during the nutrition visits, participants will have guidance on a microbiome-friendly diet and will receive groceries 1 time per week for 4 weeks.

Behavioral: Microbiome friendly diet

Interventions

Microbiome friendly diet BEHAVIORAL

Families in the intervention group will have a microbiome-friendly nutrition assessment and will also receive groceries one time per week for four weeks to help achieve a more microbiome-friendly diet.

Intervention

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child aged 6 - 11 years (not yet aged 12)
• Child with BMI ≥ 95th percentile
• Parents are willing to accept home deliveries and have the ability to be home at the time and day that is most convenient for them to receive the groceries; or, have transportation available to go and pick up groceries at a time and date that is most convenient for them at a Walmart location.

You may not qualify if:

• Does the child have a current diagnosis of obesity due to an underlying condition such as hypothyroidism, Cushing's disease, or known genetic condition?
• Is the child currently taking any weight-loss medication (steroids, anti-psychotics, anti-depressants)
• Has the child started a stimulant medication in the past 3 months? (stimulants include, among others, Ritalin, Adderall, concerta, focalin, vyvanse).
• Is the child currently taking, or has taken in the past 4 weeks, an antibiotic?
• Is the child currently taking, or plans to take in the next 4 weeks, a weight loss medication?
• Is the patient on a pharmacotherapy or weight loss surgery track in Healthy Lifestyless?
• Has the patient lost more than 5% of their body weight in the preceding 6 months?

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Healthy Lifestyles Roxboro Street

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Armstrong, MD

  Duke department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 25, 2021
• Study Start: April 9, 2021
• Primary Completion: November 20, 2021
• Study Completion: November 20, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)