Clinical trial NCT03141346: Improving the Eating Habits of Mother and Her Infant Via Sugar Reduction
Official title: Home Intervention for Reducing Sugary Drinks and Obesity in Hispanic Women-infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: mother
infant
nutrition
sugar
obesity
growth
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2017-05-05
Enrollment: 211
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal height at baseline
timeFrame: Baseline
measure: Maternal height at 6 months
timeFrame: 6 months
measure: Maternal height at 12 months
timeFrame: 12 months
measure: Maternal height at 24 months
timeFrame: 24 months
measure: Maternal weight at baseline
timeFrame: Baseline
measure: Maternal weight at 6 months
timeFrame: 6 months
measure: Maternal weight at 12 months
timeFrame: 12 months
measure: Maternal weight at 24 months
timeFrame: 24 months
measure: Maternal BMI at baseline
timeFrame: Baseline
measure: Maternal BMI at 6 months
timeFrame: 6 months
measure: Maternal BMI at 12 months
timeFrame: 12 months
measure: Maternal BMI at 24 months
timeFrame: 24 months
measure: Infant length at baseline
timeFrame: Baseline
measure: Infant length at 6 months
timeFrame: 6 months
measure: Infant length at 12 months
timeFrame: 12 months
measure: Infant length at 24 months
timeFrame: 24 months
measure: Infant weight at baseline
timeFrame: Baseline
measure: Infant weight at 6 months
timeFrame: 6 months
measure: Infant weight at 12 months
timeFrame: 12 months
measure: Infant weight at 24 months
timeFrame: 24 months
measure: Infant weight z-scores at baseline
timeFrame: Baseline
measure: Infant weight z-scores at 6 months
timeFrame: 6 months
measure: Infant weight z-scores at 12 months
timeFrame: 12 months
measure: Infant weight z-scores at 24 months
timeFrame: 24 months
measure: Infant body fat measured using an EchoMRI body composition analyzer at baseline
timeFrame: Baseline
measure: Infant body fat measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant body fat measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant body fat measured using an EchoMRI body composition analyzer at 24 months
timeFrame: 24 months
measure: Infant lean mass measured using an EchoMRI body composition analyzer at baseline
timeFrame: Baseline
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 24 months
timeFrame: 24 months
measure: Infant total body water measured using an EchoMRI body composition analyzer at baseline
timeFrame: Baseline
measure: Infant total body water measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant total body water measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant total body water measured using an EchoMRI body composition analyzer at 24 months
timeFrame: 24 months
measure: Infant free body water measured using an EchoMRI body composition analyzer at baseline
timeFrame: Baseline
measure: Infant free body water measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant free body water measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant free body water measured using an EchoMRI body composition analyzer at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Maternal pregravid BMI
timeFrame: Baseline
measure: Maternal blood pressure at baseline
timeFrame: Baseline
measure: Maternal blood pressure at 6 months
timeFrame: 6 months
measure: Maternal blood pressure at 12 months
timeFrame: 12 months
measure: Maternal blood pressure at 24 months
timeFrame: 24 months
measure: Maternal resting heart rate at baseline
timeFrame: Baseline
measure: Maternal resting heart rate at 6 months
timeFrame: 6 months
measure: Maternal resting heart rate at 12 months
timeFrame: 12 months
measure: Maternal resting heart rate at 24 months
timeFrame: 24 months
measure: Maternal diet at baseline
timeFrame: Baseline
measure: Maternal diet at 6 months
timeFrame: 6 months
measure: Maternal diet at 12 months
timeFrame: 12 months
measure: Maternal diet at 24 months
timeFrame: 24 months
measure: Infant diet at 6 months
timeFrame: 6 months
measure: Infant diet at 12 months
timeFrame: 12 months
measure: Infant diet at 24 months
timeFrame: 24 months
measure: Infant feeding score assessed by Infant Feeding Questionnaire at baseline
timeFrame: Baseline
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
timeFrame: 6 months
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 12 months
timeFrame: 12 months
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 24 months
timeFrame: 24 months
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline
timeFrame: Baseline
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
timeFrame: 6 months
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months
timeFrame: 12 months
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months
timeFrame: 24 months
measure: Infant behavior score assessed by Infant Behavior Questionnaire at baseline
timeFrame: Baseline
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
timeFrame: 6 months
measure: Infant behavior score assessed by Early Child Behavior Questionnaire at 12 months
timeFrame: 12 months
measure: Infant behavior score assessed by Early Child Behavior Questionnaire at 24 months
timeFrame: 24 months
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline
timeFrame: Baseline
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
timeFrame: 6 months
measure: Infant eating behavior score assessed by Child Eating Behavior Questionnaire at 12 months
timeFrame: 12 months
measure: Infant eating behavior score assessed by Child Eating Behavior Questionnaire at 24 months
timeFrame: 24 months
measure: Breast milk composition at baseline
timeFrame: Baseline
measure: Breast milk composition at 6 months
timeFrame: 6 months
measure: Breast milk composition at 12 months
timeFrame: 12 months
measure: Breast milk composition at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: University of Southern California; Children's Hospital Los Angeles
name: Michael I Goran
role: PRINCIPAL_INVESTIGATOR
References: