Effectiveness of an Early Nutrition Program on Promoting Breastfeeding and Optimizing Infant Growth and Diet Quality

NCT03493594 | Unknown

• 1 other identifier: CUHKFSTRC2018-01
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breastfeeding; Infant Development

Keywords

Early nutrition; Breastfeeding; Infant growth

Outcome Measures

Primary Outcomes (1)

• Success rate of breastfeeding

  success rate of breastfeeding by comparing the average duration of breastfeeding

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Diet quality

  through study completion, an average of 1 year

• Infant growth

  through study completion, an average of 1 year

• Microbiota profiles

  through study completion, an average of 1 year

Study Arms (2)

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.

Other: Nutrition education program

Interventions

Nutrition education program OTHER

online platform support, workshop, seminar and cooking demo etc

Nutrition education program

Eligibility Criteria

• Age: Up to 40 Years
• Gender Eligibility Details: the subjects are mothers and their infants so Female subjects needed to be selected while there is no sex limitation in the infants
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Full term
• Born by vaginal delivery (\>37 gestation weeks)
• singleton infant with no known abnormality.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Chinese University of Hong Kong: collaborator

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Man-sau Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuk Fan Ng, Mphil

CONTACT

85234008859; fanny.ng@polyu.edu.hk

Wing Si Vincy Wong, Degree

CONTACT

85234008783; vincyws.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 10, 2018
• Study Start: April 16, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share