Improving the Eating Habits of Mother and Her Infant Via Sugar Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-21

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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This study will 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. The postpartum period is a time of both opportunity and vulnerability for mothers and their infants to diminish risk for obesity and related health problems. This is particularly relevant in the context of Hispanic families. Hispanic mothers are at high-risk for excess gestational weight gain and postpartum weight retention, and their infants are at high-risk for rapid weight gain associated with early onset obesity. A contributing factor may be their intake of SSB/J. There is a high prevalence of reported SSB/J consumption in low-income Hispanic households, and Hispanic mothers are more likely to incorporate sweet foods during weaning. Because evidence suggests that obese Hispanic children are responsive to SSB/J reduction and substitution with non-caloric beverages, this may be a potential strategy for Hispanic mothers that may also be beneficial for their infants.

This study will be conducted in Los Angeles. Two-hundred-and-forty Hispanic mothers and their infants will be recruited. They will be randomly assigned to: group 1, a standard health education program only; group 2, a health education program that incorporates sugar reduction; and group 3, a health education program that incorporates sugar reduction with home 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. The main outcomes are maternal weight status and infant weight change. We will also assess maternal and infant diet using 24-hour recalls, and maternal feeding style and infant eating behaviors using questionnaires.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

A control health education program to promote general health and safety

Group Type ACTIVE_COMPARATOR

Control health education program

Intervention Type BEHAVIORAL

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.

Sugar Reduction Program Only

A health education program that focuses on sugar reduction

Group Type EXPERIMENTAL

Sugar reduction health education program

Intervention Type BEHAVIORAL

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 Delivery

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

Group Type EXPERIMENTAL

Sugar reduction health education program

Intervention Type BEHAVIORAL

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.

Home water delivery

Intervention Type OTHER

Home delivery of bottled water administered over 24 months

Interventions

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Sugar reduction health education program

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.

Intervention Type BEHAVIORAL

Control health education program

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.

Intervention Type BEHAVIORAL

Home water delivery

Home delivery of bottled water administered over 24 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes