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临床试验/NCT05374837
NCT05374837已完成不适用

The Impact and Implementation of a Mobile Messaging Intervention to Improve Infant and Young Child Nutrition in Senegal

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 488 人开始时间: 2022年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
488
试验地点
1
主要终点
Number of Children Who Consume a Minimum Acceptable Diet

研究概览

简要总结

This project will examine the impact of an infant and young child feeding (IYCF) voice messaging intervention delivered to mothers and fathers in Senegal on the consumption of a minimum acceptable diet and anemia prevalence in their children.

详细描述

This is a cluster-randomized control trial (cRCT) conducted with 488 mother, father, and child triads in 104 villages in three regions in Senegal: Thies, Diourbel and Fatick. Mothers and fathers in the experimental group will receive 16 voice and text messages over the course of 16 weeks. One voice and 1 text message with the same content will be sent per week over the 16 week period. We will include eight scripted messages which have previously been piloted. We will also include eight unscripted messages from positive deviants from communities similar to our study population that were included in our pilot study. A text message with the same content as the voice message will be sent to each triad mother and father to increase the reach of the intervention. We will conduct baseline and endline assessments of infant and young child feeding practices in both the experimental and control groups. Primary outcomes will include the prevalence of anemia and minimum acceptable diet in children. Minimum acceptable diet is an indicator of dietary diversity and a proxy for nutrient adequacy. Secondary outcomes include the frequency of consuming key foods targeted in the intervention over the previous 7 days and infant and young child feeding indicators of complementary feeding of the child. In addition, infant and young child feeding knowledge, beliefs, and norms (of mothers and fathers in triads) and intentions (of mothers in triads) will be included as secondary outcomes.

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

盲法说明

Given the nature of the intervention, it will not be possible to mask the treatment group at endline data collection.

入排标准

年龄范围
6 Months 至 23 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Residing in Thies, Diourbel or Fatick regions of Senegal
  • Household is member of village farming group
  • Mothers and fathers (or caregivers) that have a child 6-19 months at baseline
  • Mothers and fathers (or caregivers) that are 18 years or older
  • Mothers and fathers (or caregivers) have the ability and mental capacity to consent to their participation
  • Mother/father (or male/female caregivers) have access to mobile phone
  • Child between 6-19 months at baseline

排除标准

  • Does not meet study inclusion criteria

结局指标

主要结局

Number of Children Who Consume a Minimum Acceptable Diet

时间窗: At study completion, an average of 4 months after baseline

The minimum acceptable diet indicator will be used to assess diet quality in children. A list-based recall will be used to assess dietary intake over the previous day. The 24-hour recall will be used to calculate minimum dietary diversity (MDD) (consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) and minimum meal frequency (MMF) (2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months). Children who meet the thresholds for both MDD and MMF are defined as consuming a MAD, based on the WHO/UNICEF IYCF indicator.

Anemia Prevalence of Children

时间窗: At study completion, an average of 4 months after baseline

Hemocue Hb301 machines to measure hemoglobin levels in children in order to determine anemia prevalence using the WHO cut-offs: mild 10 ≤ hb \< 11 g/dl; moderate 7 ≤ hb \< 10 d/dl and severe hb \< 7 g/dl. A finger prick will be used to obtain a drop of capillary blood that is placed on a cuvette and inserted in the Hemocue machine to obtain an on-the-spot assessment of hemoglobin levels.

Change in Percentage of Children Consuming a Minimum Acceptable Diet Between Baseline and Endline

时间窗: Between baseline and study completion, an average of 4 months after baseline

The change in percentage of children meeting the minimum acceptable diet indicator between baseline and endline will be used to assess diet quality in children. A list-based recall will be used to assess dietary intake over the previous day. The 24-hour recall will be used to calculate minimum dietary diversity (MDD) (consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) and minimum meal frequency (MMF) (2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months). Children who meet the thresholds for both MDD and MMF are defined as consuming a MAD, based on the WHO/UNICEF IYCF indicator.

Change in Percentage of Children With Anemia Between Baseline and Endline

时间窗: Between baseline and study completion, an average of 4 months after baseline

We will use Hemocue Hb301 machines to measure hemoglobin levels in children in order to determine anemia prevalence using the WHO cut-offs: mild 10 ≤ hb \< 11 g/dl; moderate 7 ≤ hb \< 10 d/dl and severe hb \< 7 g/dl. A finger prick will be used to obtain a drop of capillary blood that is placed on a cuvette and inserted in the Hemocue machine to obtain an on-the-spot assessment of hemoglobin levels. The change in child anemia prevalence between baseline and endline will be examined (calculated as endline-baseline/baseline\*100).

次要结局

  • Frequency of Child Consuming Key Foods in the Past 7 Days(At study completion, an average of 4 months after baseline)
  • Infant and Young Child Feeding (IYCF) Practices Indicators(At study completion, an average of 4 months after baseline)
  • Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions(At study completion, an average of 4 months after baseline)
  • Number of Children Consuming Minimum Meal Frequency(At study completion, an average of 4 months after baseline)
  • Number of Children Consuming Minimum Dietary Diversity(At study completion, an average of 4 months after baseline)
  • Percent Change in Frequency of Consuming Key Foods in the Past 7 Days(Between baseline and study completion, an average of 4 months after baseline)
  • Change in Percentage of Children Meeting Recommended Infant and Young Child Feeding (IYCF) Practices Indicators(Between baseline and study completion, an average of 4 months after baseline)
  • Change in Percentage of Children Meeting Minimum Meal Frequency Indicator(Between baseline and study completion, an average of 4 months after baseline)
  • Change in Percentage of Children Meeting Minimum Dietary Diversity(Between baseline and study completion, an average of 4 months after baseline)
  • Change in Percentage of Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions(Between baseline and study completion, an average of 4 months after baseline)

研究者

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

Shauna Downs, PhD MS

Assistant Professor

Rutgers, The State University of New Jersey

研究点 (1)

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