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临床试验/NCT03493594
NCT03493594Unknown不适用

Effectiveness of a Community Based Early Nutrition Program on Promoting Breastfeeding and Optimizing Infant Growth and Diet Quality

The Hong Kong Polytechnic University0 个研究点目标入组 96 人开始时间: 2018年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
96
主要终点
Success rate of breastfeeding

研究概览

简要总结

Effective early life programs that reduce the long-term non-communicable diseases (NCDs) risk could bring great economic benefits to the society. However, there is a lack of local data on the effect of nutrition on child growth and most research on early life intervention focus on disease models such as obese women to improve offspring health outcomes. There is limited research on postpartum interventions in the community that optimize maternal and infant nutrition through improving success of breastfeeding, infant growth diet quality and microbiota to enhance health in the adulthood.

In this study, it is hypothesized that our early nutrition program could promote breastfeeding successful rate (increase the number of months the mothers breastfed their infants) and improve growth status, diet quality and microbiota of the infants which may reduce the risk of NCDs in the adulthood. The planned project proposal would like to include 240 pairs of mothers and infants. In order to test the protocol in the planned proposal, the investigators hope to run a pilot study to set up this community based early nutrition program including breastfeeding workshops and supports, healthy lifestyle courses, parenting education, introduction of solid foods for infants, child development and cooking classes of infant foods. the investigators will evaluate the effectiveness of this early nutrition program and determine its impacts on breastfeeding, infant growth (by comparing infants' biomarkers and microbiota in different stages) , diet quality and microbiota, as well as the benefits to the postpartum mothers such as reducing the postpartum weight retention so that to generate pilot result and facilitate the up scale study that the investigators proposed in the planned proposal.

The ultimate goal is that a long term follow up with the children in this project could also be arranged to determine the long term health effects of this early nutrition program.

详细描述

Study background:

Effective early life programs that reduce the long-term non-communicable diseases (NCDs) risk could bring great economic benefits to the society. NCDs are responsible for roughly two-thirds of worldwide death and cause large burden of health care cost. Most policies nowadays that combat disease focus on treatment after disease occurs and on reducing risk factors in adult life. Early life interventions are an unexplored and promising new avenue of health policy . One of the oldest US early life intervention programs, the Carolina Abecedarian Project, started from 1970s has been shown to have substantial benefits in boosting adult health. However, most research on early life intervention focus on disease models such as obese women to improve offspring health outcomes. There is limited research on postpartum interventions in the community that optimize maternal and infant nutrition through improving success of breastfeeding, infant growth, diet quality and microbiota to enhance health in the adulthood

Aim of study:

To evaluate the effects of postpartum nutrition program on i) success of breastfeeding by comparing the average duration of breastfeeding between intervention group and control group (primary outcome) ii) diet quality of the infants and mothers (secondary outcome) The diet quality will be measured by 3-day dietary records using Diet Quality Index-International (DQI-I).

Briefly, the DQI-I assesses four categories (variety, adequacy, moderation, and overall balance) and contains six food items and 11 nutrient items. This scoring scale is complex. The maximum possible score for each category ranges from 10 to 40 points, and the full score is 100 points.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
— 至 40 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for mothers:
  • •Postpartum mothers: Aged 18-40 years old
  • •Hong Kong residents having resided in Hong Kong for a continuous period of not less than 18 months
  • •vaginal delivery at full term (>37 gestation weeks)
  • •first pregnancy and give birth to singleton infant
  • •Inclusion Criteria for Infants:
  • •Full term
  • •Born by vaginal delivery (>37 gestation weeks)
  • •singleton infant with no known abnormality.

排除标准

  • •Concurrent participation in any clinical trial or study
  • •Complicated pregnancy such as preeclampsia and gestational diabetes
  • •Special dietary restrictions for examples gluten-free diets, vegan or any restrictions due to food allergies;
  • •Suffer from renal, liver or thyroid dysfunction, cognitive impairment, or any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study.

研究组 & 干预措施

Control

No Intervention

Control group will receive standard health care.

To improve the compliance of the subjects, both intervention group and control group can attend one vision development workshop at 2-month postpartum and two parenting workshops at 6- and 12-month postpartum.

Nutrition education program

Experimental

The intervention group will receive an early nutrition program for 12 months. Workshops format will be mainly in form of talks and experience sharing groups which run by lactation consultants, nutritionists / dietitians. All classes and workshops will be run for 4-6 times to cater for subjects recruited in different phases.

To improve the compliance of the subjects, both intervention group and control group can attend one vision development workshop at 2-month postpartum and two parenting workshops at 6- and 12-month postpartum.

干预措施: Nutrition education program (Other)

结局指标

主要结局

Success rate of breastfeeding

时间窗: through study completion, an average of 1 year

success rate of breastfeeding by comparing the average duration of breastfeeding

次要结局

  • Microbiota profiles(through study completion, an average of 1 year)
  • Diet quality(through study completion, an average of 1 year)
  • Infant growth(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Man-sau WONG

Professor

The Hong Kong Polytechnic University

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