NCT03141346

Brief Summary

The purpose of this study is to determine whether a health education program incorporating sugar sweetened beverage and juice (SSB/J) reduction and home water delivery affects maternal and infant risk for obesity by randomizing mother-infant dyads to one of three 24-month interventions: Group 1 (control): standard health education program only; Group 2 (translation): health education program focused on sugar reduction; and Group 3 (efficacy): health education program focused on sugar reduction and bottled water delivery. The intervention program will be delivered by trained health educators during in-person home visits, or virtually via phone or video calls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 21, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2023

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

6.1 years

First QC Date

May 1, 2017

Last Update Submit

March 12, 2026

Conditions

Obesity

Keywords

motherinfantnutritionsugarobesitygrowth

Outcome Measures

Primary Outcomes (40)

  • Maternal height at baseline

    Height (cm) will be measured using a stadiometer.

    Baseline

  • Maternal height at 6 months

    Height (cm) will be measured using a stadiometer.

    6 months

  • Maternal height at 12 months

    Height (cm) will be measured using a stadiometer.

    12 months

  • Maternal height at 24 months

    Height (cm) will be measured using a stadiometer.

    24 months

  • Maternal weight at baseline

    Weight (kg) will be measured using a portable digital scale.

    Baseline

  • Maternal weight at 6 months

    Weight (kg) will be measured using a portable digital scale.

    6 months

  • Maternal weight at 12 months

    Weight (kg) will be measured using a portable digital scale.

    12 months

  • Maternal weight at 24 months

    Weight (kg) will be measured using a portable digital scale.

    24 months

  • Maternal BMI at baseline

    Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.

    Baseline

  • Maternal BMI at 6 months

    Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.

    6 months

  • Maternal BMI at 12 months

    Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.

    12 months

  • Maternal BMI at 24 months

    Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.

    24 months

  • Infant length at baseline

    Infant length (cm) will be measured using an infant measure mat.

    Baseline

  • Infant length at 6 months

    Infant length (cm) will be measured using an infant measure mat.

    6 months

  • Infant length at 12 months

    Infant length (cm) will be measured using an infant measure mat.

    12 months

  • Infant length at 24 months

    Infant length (cm) will be measured using an infant measure mat.

    24 months

  • Infant weight at baseline

    Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).

    Baseline

  • Infant weight at 6 months

    Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).

    6 months

  • Infant weight at 12 months

    Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).

    12 months

  • Infant weight at 24 months

    Infant weight (kg) will measured using a portable digital scale. For infants that need to be held, weight will be calculated as follows: (combined mother + infant weight) - (mother only weight).

    24 months

  • Infant weight z-scores at baseline

    Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.

    Baseline

  • Infant weight z-scores at 6 months

    Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.

    6 months

  • Infant weight z-scores at 12 months

    Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.

    12 months

  • Infant weight z-scores at 24 months

    Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.

    24 months

  • Infant body fat measured using an EchoMRI body composition analyzer at baseline

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

    Baseline

  • Infant body fat measured using an EchoMRI body composition analyzer at 6 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

    6 months

  • Infant body fat measured using an EchoMRI body composition analyzer at 12 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

    12 months

  • Infant body fat measured using an EchoMRI body composition analyzer at 24 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

    24 months

  • Infant lean mass measured using an EchoMRI body composition analyzer at baseline

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

    Baseline

  • Infant lean mass measured using an EchoMRI body composition analyzer at 6 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

    6 months

  • Infant lean mass measured using an EchoMRI body composition analyzer at 12 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

    12 months

  • Infant lean mass measured using an EchoMRI body composition analyzer at 24 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

    24 months

  • Infant total body water measured using an EchoMRI body composition analyzer at baseline

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

    Baseline

  • Infant total body water measured using an EchoMRI body composition analyzer at 6 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

    6 months

  • Infant total body water measured using an EchoMRI body composition analyzer at 12 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

    12 months

  • Infant total body water measured using an EchoMRI body composition analyzer at 24 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

    24 months

  • Infant free body water measured using an EchoMRI body composition analyzer at baseline

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

    Baseline

  • Infant free body water measured using an EchoMRI body composition analyzer at 6 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

    6 months

  • Infant free body water measured using an EchoMRI body composition analyzer at 12 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

    12 months

  • Infant free body water measured using an EchoMRI body composition analyzer at 24 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

    24 months

Secondary Outcomes (36)

  • Maternal pregravid BMI

    Baseline

  • Maternal blood pressure at baseline

    Baseline

  • Maternal blood pressure at 6 months

    6 months

  • Maternal blood pressure at 12 months

    12 months

  • Maternal blood pressure at 24 months

    24 months

  • +31 more secondary outcomes

Study Arms (3)

Control

ACTIVE COMPARATOR

A control health education program to promote general health and safety

Behavioral: Control health education program

Sugar Reduction Program Only

EXPERIMENTAL

A health education program that focuses on sugar reduction

Behavioral: Sugar reduction health education program

Sugar Reduction Program & Water Delivery

EXPERIMENTAL

A health education program that focuses on sugar reduction and provides home bottled water delivery

Behavioral: Sugar reduction health education programOther: Home water delivery

Interventions

Sugar reduction health education programBEHAVIORAL

A health education program incorporating sugar reduction education and monitoring provided by a trained health educator over 24 months. The intervention program will be delivered by the health educator during in-person home visits, or virtually via phone or video calls.

Sugar Reduction Program & Water DeliverySugar Reduction Program Only
Control health education programBEHAVIORAL

Control health education program provided by a trained health educator over 24 months. The intervention program will be delivered by the health educator during in-person home visits, or virtually via phone or video calls.

Control
Home water deliveryOTHER

Home delivery of bottled water administered over 24 months

Sugar Reduction Program & Water Delivery

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers who self-identify as Hispanic
  • Mothers who have or have had singleton births
  • Mothers will be recruited prior to their infant's birth or up to 1-month postpartum
  • Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level
  • Mothers who are habitual consumers of sugar sweetened beverages and juices

You may not qualify if:

  • Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
  • Physical, mental, or cognitive issues that prevent participation
  • Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
  • Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
  • Clinical diagnosis of gestational diabetes
  • Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities
  • Mothers less than 18 years of age at the time of delivery will not be eligible as to avoid potential confounding from those subjects who might still be completing adolescent growth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (1)

  • Machle CJ, Berger PK, Salvy SJ, Rios C, Durazo-Arvizu R, Goran MI. Efficacy of a 24-month behavioral intervention focused on sugary beverage reduction for Latino mother-infant dyads: evidence from a randomized controlled trial. Am J Clin Nutr. 2025 Feb;121(2):355-366. doi: 10.1016/j.ajcnut.2024.11.009. Epub 2025 Jan 9.

    PMID: 39909707DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael I Goran

    University of Southern California; Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
USC Faculty/Non Physician

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 5, 2017

Study Start

September 21, 2017

Primary Completion

October 21, 2023

Study Completion

October 21, 2023

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)