跳至主要内容
临床试验/NCT03689504
NCT03689504已完成不适用

Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala

Wuqu' Kawoq, Maya Health Alliance1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child

研究概览

简要总结

This is a pilot quasi-experimental study to evaluate the impact of adding a family garden intervention to an existing wrap-around nutrition intervention for children with chronic malnutrition and their family. The existing nutrition intervention is provided by community health workers affiliated with Wuqu' Kawoq | Maya Health Alliance. A single community in rural Guatemala will participate in the intervention, with the goal to recruit approximately 70 families in the combined nutrition/garden intervention. A nearby community, also participating in the nutrition intervention, will serve as a nonrandom contemporaneous control.

Aims of the study include:

  1. Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity.
  2. Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children who are already scheduled to be enrolled in Maya Health Alliance's intensive home-based nutrition program (non-investigational, standard of care) who are 6-24 months of age at the time of enrollment with a height-for-age Z scores of <= -2.5
  • At least one caregiver willing to provide written informed consent
  • Caregiver of a child enrolled in the study (for caregiver/head of household outcomes), including women who may be pregnant
  • Planned residence in the study area for the next 18 months

排除标准

  • Children with acute malnutrition (weight for length Z scores of <= -2.0)
  • Children with a severe medical illness that affects growth (e.g., heart disease, kidney disease, genetic condition) as determined by a Maya Health Alliance staff physician.
  • Caregivers with cognitive impairments that prevent them from being able to provide informed consent

结局指标

主要结局

Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child

时间窗: Baseline, 6 months

Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool

Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child

时间窗: Baseline, 6 months

Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool

Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household

时间窗: Baseline, 6 months

Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall

Change From Baseline in Raw Household Food Insecurity Score at 6 Months

时间窗: Baseline, 6 months

Standardized food insecurity score, using the Food and Agriculture Organization's Global Food Insecurity Experience Scale (possible score range 0-8), higher scores indicate more food insecurity

次要结局

  • Change in Weight for Height/Length Z Score From Baseline to 6 Months(Baseline, 6 months)
  • Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score(Baseline, 6 months)
  • Change in Height/Length for Age Z Score From Baseline to 6 Months(0 months (baseline), 6 months)
  • Change in Weight for Age Z Score From Baseline to 6 Months(0 months (Baseline), 6 months)

研究者

发起方
Wuqu' Kawoq, Maya Health Alliance
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验