CompletedNot Applicable

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

United States211 participantsStarted 2017-09-21

Plain-language 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.

Who can participate

Age range18 Years – 59 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Maternal height at baseline

Timeframe: Baseline

Maternal height at 6 months

Timeframe: 6 months

Maternal height at 12 months

Timeframe: 12 months

Maternal height at 24 months

Timeframe: 24 months

Maternal weight at baseline

Timeframe: Baseline

Maternal weight at 6 months

Timeframe: 6 months

Maternal weight at 12 months

Timeframe: 12 months

Maternal weight at 24 months

Timeframe: 24 months

Maternal BMI at baseline

Timeframe: Baseline

Trial details

NCT IDNCT03141346

SponsorChildren's Hospital Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-21

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range18 Years – 59 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maternal height at baseline

Timeframe: Baseline

Maternal height at 6 months

Timeframe: 6 months

Maternal height at 12 months

Timeframe: 12 months

Maternal height at 24 months

Timeframe: 24 months

Maternal weight at baseline

Timeframe: Baseline

Maternal weight at 6 months

Timeframe: 6 months

Maternal weight at 12 months

Timeframe: 12 months

Maternal weight at 24 months

Timeframe: 24 months

Maternal BMI at baseline

Timeframe: Baseline