Home Intervention for Reducing Sugary Drinks and Obesity in Hispanic Women-infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Maternal height at baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
A control health education program to promote general health and safety
干预措施: Control health education program (Behavioral)
Sugar Reduction Program Only
A health education program that focuses on sugar reduction
干预措施: Sugar reduction health education program (Behavioral)
Sugar Reduction Program & Water Delivery
A health education program that focuses on sugar reduction and provides home bottled water delivery
干预措施: Sugar reduction health education program (Behavioral)
Sugar Reduction Program & Water Delivery
A health education program that focuses on sugar reduction and provides home bottled water delivery
干预措施: Home water delivery (Other)
结局指标
主要结局
Maternal height at baseline
时间窗: Baseline
Height (cm) will be measured using a stadiometer.
Maternal weight at baseline
时间窗: Baseline
Weight (kg) will be measured using a portable digital scale.
Maternal weight at 6 months
时间窗: 6 months
Weight (kg) will be measured using a portable digital scale.
Maternal weight at 12 months
时间窗: 12 months
Weight (kg) will be measured using a portable digital scale.
Maternal weight at 24 months
时间窗: 24 months
Weight (kg) will be measured using a portable digital scale.
Maternal BMI at baseline
时间窗: Baseline
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Maternal BMI at 6 months
时间窗: 6 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Maternal BMI at 24 months
时间窗: 24 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Maternal height at 6 months
时间窗: 6 months
Height (cm) will be measured using a stadiometer.
Maternal height at 12 months
时间窗: 12 months
Height (cm) will be measured using a stadiometer.
Maternal height at 24 months
时间窗: 24 months
Height (cm) will be measured using a stadiometer.
Infant length at 6 months
时间窗: 6 months
Infant length (cm) will be measured using an infant measure mat.
Infant lean mass measured using an EchoMRI body composition analyzer at 24 months
时间窗: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Maternal BMI at 12 months
时间窗: 12 months
Body Mass Index (BMI) will be calculated based on the equation (weight in kg)/(height in m)\^2.
Infant length at baseline
时间窗: Baseline
Infant length (cm) will be measured using an infant measure mat.
Infant length at 12 months
时间窗: 12 months
Infant length (cm) will be measured using an infant measure mat.
Infant length at 24 months
时间窗: 24 months
Infant length (cm) will be measured using an infant measure mat.
Infant weight z-scores at baseline
时间窗: 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.
Infant body fat measured using an EchoMRI body composition analyzer at baseline
时间窗: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant weight at baseline
时间窗: 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).
Infant weight at 6 months
时间窗: 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).
Infant weight at 24 months
时间窗: 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).
Infant weight z-scores at 12 months
时间窗: 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.
Infant weight z-scores at 24 months
时间窗: 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.
Infant body fat measured using an EchoMRI body composition analyzer at 12 months
时间窗: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant total body water measured using an EchoMRI body composition analyzer at baseline
时间窗: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant weight at 12 months
时间窗: 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).
Infant weight z-scores at 6 months
时间窗: 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.
Infant body fat measured using an EchoMRI body composition analyzer at 6 months
时间窗: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant body fat measured using an EchoMRI body composition analyzer at 24 months
时间窗: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at baseline
时间窗: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
时间窗: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 12 months
时间窗: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 24 months
时间窗: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
时间窗: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 6 months
时间窗: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at baseline
时间窗: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 6 months
时间窗: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 12 months
时间窗: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 24 months
时间窗: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
次要结局
- Maternal blood pressure at baseline(Baseline)
- Maternal blood pressure at 12 months(12 months)
- Maternal resting heart rate at 12 months(12 months)
- Maternal pregravid BMI(Baseline)
- Maternal blood pressure at 6 months(6 months)
- Maternal blood pressure at 24 months(24 months)
- Maternal resting heart rate at baseline(Baseline)
- Maternal resting heart rate at 6 months(6 months)
- Maternal diet at 12 months(12 months)
- Infant diet at 6 months(6 months)
- Infant diet at 24 months(24 months)
- Maternal resting heart rate at 24 months(24 months)
- Maternal diet at 6 months(6 months)
- Maternal diet at baseline(Baseline)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline(Baseline)
- Infant behavior score assessed by Infant Behavior Questionnaire at baseline(Baseline)
- Maternal diet at 24 months(24 months)
- Infant diet at 12 months(12 months)
- Infant feeding score assessed by Infant Feeding Questionnaire at baseline(Baseline)
- Infant feeding score assessed by Infant Feeding Questionnaire at 6 months(6 months)
- Infant feeding score assessed by Infant Feeding Questionnaire at 12 months(12 months)
- Infant feeding score assessed by Infant Feeding Questionnaire at 24 months(24 months)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months(6 months)
- Infant behavior score assessed by Early Child Behavior Questionnaire at 12 months(12 months)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months(6 months)
- Infant eating behavior score assessed by Child Eating Behavior Questionnaire at 12 months(12 months)
- Breast milk composition at baseline(Baseline)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months(12 months)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months(24 months)
- Infant behavior score assessed by Infant Behavior Questionnaire at 6 months(6 months)
- Infant behavior score assessed by Early Child Behavior Questionnaire at 24 months(24 months)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline(Baseline)
- Infant eating behavior score assessed by Child Eating Behavior Questionnaire at 24 months(24 months)
- Breast milk composition at 6 months(6 months)
- Breast milk composition at 12 months(12 months)
- Breast milk composition at 24 months(24 months)
研究者
Michael Goran
USC Faculty/Non Physician
Children's Hospital Los Angeles