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临床试验/NCT06898346
NCT06898346招募中不适用

Maternal Health, Literacy and Pregnancy Outcomes: The Role of Specialized Nutrition Education

Yale University2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年3月31日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
Dietary Diversity in Women

研究概览

简要总结

This study is designed to test a nutrition education program that focuses on local foods in northern Ghana. The goal is to help pregnant women eat a wider variety of foods, increase their intake of protein, energy, and iron-rich foods, and support healthy weight gain during pregnancy. We want to understand how this program impacts mothers' knowledge about nutrition and health, and how it affects the health of their babies. The program was created with input from pregnant women and health professionals in the community.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparous pregnant (first-time) mothers (BMI<20kg/m2) between the ages of 18 and 40 attending antenatal sessions and in their second trimester, gestational ages (GA) of 16 weeks to 20 weeks, who are not carrying multiple fetuses

排除标准

  • Women with pregnancies greater than 20 weeks gestation, to ensure adequate exposure to the intervention; mothers presenting with significant morbidity or who are admitted due to complications and mothers who cannot confirm an address or contact information and do not plan to deliver at a health facility as well as those who indicate that they would not deliver in the study region (those who will be out of town at time of delivery).

研究组 & 干预措施

Intervention

Experimental

The treatment group will receive 6 nutrition education and counseling sessions

干预措施: Nutrition Education (Behavioral)

Control

No Intervention

The control group will not receive the program's nutrition education intervention, However, to minimize the Hawthorne effect (Sedgwick, 2012) on the intervention, the control group will be visited as well but will receive education on personal hygiene only. All participants will continue to receive any education that is part of standard care from their primary care providers

结局指标

主要结局

Dietary Diversity in Women

时间窗: 15-17 weeks

Maternal dietary diversity will also be determined from 24-hr recalls by assessing how many food groups a woman consumed each day based on FAO definitions (FAO and FHI 360, 2016)

Health Literacy

时间窗: 10-12 weeks

Health literacy (HL) in women will be assessed using the All Aspects of Health Literacy Scale (AAHLS) developed by Chinn and McCarthy (2013), and maternal health literacy (MHL) will be assessed using an abridged version of the Maternal Health Literacy Inventory In Pregnancy (MHELIP) (Taheri et al, 2020).

次要结局

  • Nutrition Knowledge(15-17 weeks)
  • Infant birth weight(20 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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