The Healthy Lifestyles Passport Program: a Randomized Control Trial of a Prenatal Maternal Education Program to Prevent Infant and Childhood Obesity (HLPP)
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in child's gender-specific weight-for-length (WFL) z-score
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the Healthy Lifestyles Passport Program (HLPP) in preventing infant and childhood obesity. It is hypothesized that the participants in the intervention arm will exhibit less excessive weight-for-length gain from 4- to 6-months of age. In 2-years and 5-years, it is predicted that the participants in the intervention arm will yield lower Body Mass Index (BMI) z-scores than the participants in the control arm, who receive usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women during the third trimester (>28 weeks gestation) receiving care in the institution's Women's Health Center
- •no medical conditions complicating their pregnancy
- •must be able to communicate in English or Spanish
- •be reachable by phone
- •plan to be the consistent caretaker of the child at least 75% of the time
- •plan to attend the institution's pediatric outpatient clinic for the child's routine healthcare
排除标准
- •Child with any disabling or chronic illnesses
- •Any existing and/or pre-existing disabling or chronic illnesses that would qualify the mother as "high risk"
- •Wards of the state
- •Mothers with a disabling/serious chronic illness
- •Drug/alcohol use during pregnancy
研究组 & 干预措施
Usual Care
The Usual Care arm, will not be receiving the interactive nutrition education. They will be meeting with the Registered Dietitian twice in person after the participants are randomized in each arm, and once on the phone. The first meeting, they will be receiving pamphlets and handouts, which are typically given as part of usual care. The second meeting is a post-test assessment and Newest Vital Sign Assessment Tool. The second meeting and the follow-up phone call are both the same for usual care and the Healthy Lifestyles Passport arm.
Healthy Lifestyles Passport
The Healthy Lifestyles Passport arm will be receiving the intervention. They will be meeting with the Registered Dietitian twice in person after the participants are randomized into each arm, and once on the phone. The first meeting, they will be receiving the Healthy Lifestyles Passport, including the interactive nutrition education. The second meeting is a post-test assessment and Newest Vital Sign Assessment Tool.
干预措施: Healthy Lifestyles Passport (Other)
结局指标
主要结局
Change in child's gender-specific weight-for-length (WFL) z-score
时间窗: 4-months to 6-months of the child's age
The child's weight and length will be extracted from the medical record at the child's 4-month and 6-month old office visit and the weight-for-length z-scores will be calculated. The difference between each arm's z-score will be compared.
次要结局
- Child's Body Mass Index (BMI)(At 2-years and 5-years of the child's age.)
- Mother's Knowledge, Skill, Attitude and Behavior.(Baseline, day after the intervention and two months after the baby is born.)
研究者
Mamta Reddy, MD
Director, Pediatric Asthma Center; Chief, Allergy/Immunology
Bronx-Lebanon Hospital Center Health Care System