Response of the Gut Microbiome and Circulating Metabolome to Diet in Children: Ancillary Study to KIDFIT (NCT03405246)

NCT03612479 | Completed DMC

• 1 other identifier: STU00207041
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is an ancillary study to KIDFIT (NCT03405246). KIDFIT tests whether preschool-age children, born to overweight or obese mothers, respond to a healthy DASH diet intervention with better cardiovascular health. This ancillary study to KIDFIT investigates how the children's gut microbiomes (bacteria in the intestines) and blood metabolomes (small molecules in the blood) are affected by the DASH diet intervention, and how the microbiome and metabolome relate to the children's cardiovascular health over time. The investigators hypothesize that (1) the DASH diet will modify the gut microbiome and blood metabolome, (2) the gut microbiome and blood metabolome will be related to each other, and (3) the microbiome and metabolome will be associated with the children's cardiovascular health profiles (things like weight, body fat, blood pressure, and cholesterol).

Conditions

Gastrointestinal Microbiome; Metabolome; Pediatric Obesity; Dietary Approaches to Stop Hypertension

Outcome Measures

Primary Outcomes (2)

• Gut microbiome

  abundances of gut microbial taxa, communities, and metabolic pathways activity

  changes from baseline to 12 months

• Blood metabolome

  abundances of blood metabolites, metabolic networks, and metabolic pathways activity

  changes from baseline to 12 months

Study Arms (2)

KIDFIT Healthy

EXPERIMENTAL

Behavioral: KIDFIT Healthy

KIDFIT Safe

ACTIVE COMPARATOR

Behavioral: KIDFIT Safe

Interventions

KIDFIT Healthy BEHAVIORAL

The KIDFIT Healthy intervention promotes the DASH diet, physical activity, limited screen time, and adequate sleep, through a combination of traditional in-person and electronic participant contacts. See NCT03405246 for details.

Also known as: Intervention Group

KIDFIT Healthy

KIDFIT Safe BEHAVIORAL

The KIDFIT Safe active control provides electronic material about safe home environments and activities (e.g., sun screen, choking hazards, pet safety) for children. See NCT03405246 for details.

Also known as: Control Group

KIDFIT Safe

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- participating in KIDFIT (NCT03405246)

You may not qualify if:

• \- none

Sponsors & Collaborators

• Northwestern University: lead
• American Heart Association: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Northwestern University Department of Preventive Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Amanda Marma Perak, MD MS

  Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Pediatrics-Cardiology and Preventive Medicine

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: July 10, 2018
• Primary Completion: November 9, 2020
• Study Completion: November 16, 2020
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)