跳至主要内容
临床试验/NCT01746394
NCT01746394已完成不适用

Delta Healthy Sprouts: A Randomized Trial to Determine the Comparative Efficacy of Two Maternal, Infant, and Early Childhood Home Visiting Programs on Maternal Weight Control and Childhood Obesity in the Mississippi Delta

USDA, Delta Human Nutrition Research Program1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
Maternal dietary intake

研究概览

简要总结

The Delta Healthy Sprouts Project is a randomized, controlled trial evaluating the enhancement of an existing Mother, Infant, and Early Childhood Home Visiting Program in 150 African American women in their early second trimester of pregnancy. The control arm, Parents as Teachers, is an evidence-based approach to increase parental knowledge of child development and improve parenting practices. The experimental arm, Parents as Teachers Enhanced, builds on the Parents as Teachers curriculum by including nutrition and physical activity components specifically designed for the gestational and postnatal periods. Both arms of the intervention will be implemented by community-based, trained Parent Educators. The comparative effectiveness of the two intervention arms on weight status, dietary intake, and health behaviors of mothers and their infants will be assessed. The Delta Healthy Sprouts Project will determine if a novel, scalable, lifestyle intervention can improve the health of African American women and their children at high-risk for obesity and chronic disease.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •At least 18 years of age
  • •Less than 18 weeks pregnant with first, second, or third child
  • •Resident of Mississippi counties of Washington and Bolivar

排除标准

  • •Pregnant with more than one fetus

研究组 & 干预措施

Parents as Teachers Enhanced

Experimental

Participants in the Parents as Teachers Enhanced (PaTE) intervention arm will receive the enhanced diet and activity maternal, infant, and early childhood home visiting program

干预措施: Parents as Teachers Enhanced (Behavioral)

Parents as Teachers Enhanced

Experimental

Participants in the Parents as Teachers Enhanced (PaTE) intervention arm will receive the enhanced diet and activity maternal, infant, and early childhood home visiting program

干预措施: Parents as Teachers (Behavioral)

Parents as Teachers

Active Comparator

Participants in the Parents as Teachers (PaT) control arm will receive the standard maternal, infant, and early childhood home visiting program

干预措施: Parents as Teachers (Behavioral)

结局指标

主要结局

Maternal dietary intake

时间窗: 12 months postpartum

Dietary intake measured using 24-hour dietary recall

Infant activity

时间窗: 12 months after birth

Activity measured using responses to questions concerning time spent confined (e.g. in infant seat) and unconfined (e.g. on play mat)

Infant body mass index

时间窗: 12 months after birth

Incremental body mass index during the first year of life

Maternal postpartum weight retention

时间窗: 12 months postnatal

Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight

Maternal physical activity

时间窗: 12 months postpartum

Physical activity measured using a physical activity questionnaire

Gestational weight gain

时间窗: 9 months gestation

Percentages of gestational weight gain which fall within the ranges recommended by the Institute of Medicine (based on pre-pregnancy body mass index)

Infant dietary intake

时间窗: 12 months after birth

Dietary intake measured using 24-hour dietary recall as reported by mother

次要结局

  • Breastfeeding(12 months postpartum)
  • Home food environment(12 months postpartum)

研究者

发起方
USDA, Delta Human Nutrition Research Program
申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验