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临床试验/NCT05525429
NCT05525429已完成不适用

Integrated Approach to Enhance Milk Consumption by Vulnerable Household Members in Rural Nepal

Tufts University1 个研究点 分布在 1 个国家目标入组 1,873 人开始时间: 2024年6月8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
入组人数
1,873
试验地点
1
主要终点
Number of Animal Source Foods Consumed in prior 24 hours (diet recall survey), baseline to endline

研究概览

简要总结

Diet quality is generally poor in rural Nepal, especially among vulnerable household members. Consumption of milk (and other animal source foods [ASF]) could contribute to improvements in diet quality. However, multiple cultural, structural and economic barriers constrain the inclusion of ASF in the diet in these households, even though most raise dairy animals. This study will

  1. characterize these barriers in detail
  2. conduct a randomized controlled trial to test a multi-dimensional behavior change intervention designed to increase ASF/milk consumption by young children 6-60 months, adolescent girls 10-15 years, and women of child-bearing age (WCBA).

Matched clusters of villages in Kapilbastu and Nawalparasi districts (Nepal) will be randomized to Intervention or Control status. Household surveys will be conducted at baseline and 12 months later to collect demographic, diet, feeding practices, nutrition knowledge, etc. Fathers and adolescent girls will respond to mini-surveys. Growth parameters of children, adolescent girls, and WCBA will be assessed. The intervention consists of 4 components: 1) didactic training (mothers, fathers, adolescent girls), 2) participatory learning activities (mothers, fathers, adolescent girls), 3) model kitchens (mothers, adolescent girls), and 4) Nutrition Club (adolescent girls).

The primary outcome will be the impact of the intervention on diet, household feeding practices, and nutrition knowledge.

详细描述

Animal-source-foods (ASF) contains nutrients essential to human health. These nutrients are especially important for vulnerable household members (young children, adolescent girls, women of child-bearing age [WCBA]). 1, 2 In developing countries, milk is generally one of the largest sources and most widely consumed animal-based dietary protein 3

Although livestock farmers are more likely than their counterparts to consume ASF 3-5, paradoxically, families that rely on agriculture and livestock production for their livelihoods are significantly food and nutrition insecure households. This is partly due to use of the income earned from livestock for purposes other than improving household diet diversity and quality, and partly due to inadequate knowledge about the importance of doing so. In addition, household food allocation practices and cultural beliefs and taboos impact ASF consumption by individual family members. ASF consumption in Nepal, for example, is often prioritized for the primary household bread winner (usually an adult male) 6. Thus, multiple cultural, structural and economic barriers converge to limit consumption of ASF by vulnerable household memb8rs.

Many governmental and non-governmental organizations attempt to improve diet quality in rural households via nutrition education in hopes of motivating behavior change among participants. However, results of such programs have been inconsistent and generally disappointing 7-9. Even programs which provide a robust agricultural intervention are not always successful in improving diets or child growth 10, 11. Therefore, the study will define the barriers to household ASF consumption in rural Nepal and introduce a package of solutions to overcome these barriers. The design of the intervention builds on prior formative work 1, 12-20 21, and will be tested in a randomized controlled trial. While young children under 5 years of age remain a strong focus of this work, adolescent girls, WCBA and fathers will also be included in the intervention activities.

This intervention addresses implementation gaps identified in the investigators' prior work and incorporates findings in recent literature regarding the effectiveness of specific behavior change interventions on nutrition outcomes 22. The investigators' previous work demonstrated that barriers to improving child nutrition are not overcome by increased income, nutrition education, or enhanced household milk production. Recent work has highlighted the value of specific components of behavior change programs: (1) demonstrations of how to perform the behavior, (2) cooking/recipe demonstrations, (3) restructuring the social environment (e.g., women's groups) and engaging with fathers and other groups not typically included, (4) providing households with prompts/cues, (5) action planning, goal-setting and problem-solving, (6) providing information about health consequences, (7) offering strategies to families to self-monitor behaviors. This planned multi-faceted intervention incorporates these elements to augment the effectiveness of behavior change messaging provided to household members, while strengthening community involvement, fostering sustainability and facilitating scaling-up activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Months 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Households involved with Heifer Project International activities. Mothers participate in women's self-help group. Household has at least 1 child 6-60 months at baseline. Household is will to participate.

排除标准

  • unwillingness to participate in the research activity, plans to leave the area within the next 12 months, or child 6-60 months or adolescent girl with physical or other special needs that prevent the ingestion of a normal diet-for-age. For adolescent girls, an additional exclusion criterion is the presence of any issues that interfere with their ability to respond.

研究组 & 干预措施

Nutrition Education

Active Comparator

Households in this arm will participate in a multidimensional nutrition education intervention, including (1) didactic training on family nutrition (mothers, fathers, adolescent girls), (2) participatory learning activities (mothers, fathers, adolescent girls), (3) model kitchens (mothers, adolescent girls), and (4) Nutrition Club (adolescent girls).

干预措施: Nutrition Education (Behavioral)

Control

No Intervention

No intervention will be provided. After the research period is complete, the Control group will receive all inputs described above, but no data will be collected during this time period.

结局指标

主要结局

Number of Animal Source Foods Consumed in prior 24 hours (diet recall survey), baseline to endline

时间窗: ~1 year

Impact of nutrition education on diet of mothers, children 6-60 months, and adolescent girls will compared between baseline and endline.

次要结局

  • Change in height-for-age z score from baseline to endline for children 6-60 months(~1 year)
  • Change in head circumference-for-age z score from baseline to endline for children 6-60 months(~1 year)
  • Change in BMI from baseline to endline for adolescent girls(~1 year)

研究者

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

Laurie Miller, MD

Professor of Pediatrics

Tufts University

研究点 (1)

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