NCT03886467

Brief Summary

Dairy animals are an important source of income, food and nutrition security at the household level. However, substandard animal husbandry practices and limited understanding of disease prevention and control may limit dairy animal productivity. Interventions to address these issues may enhance milk production, substantially improving the well-being of smallholder farmers. In addition to increasing household income, greater milk production may improve the diet quality of household members, particularly children. Previously, the investigators implemented a program in rural Nepal promoting enhanced animal husbandry practices (GHP), focusing on mastitis control. Concurrently, the investigators found child milk intake was strongly linked to better growth and development. However, milk intake was limited and its availability was not examined. The investigators now propose to build on these prior activities and examine strategies to increase child milk consumption. The investigators plan to introduce a nutrition education program into 200 households (with young children) which previously received GHP training. A comparison group of 200 households will serve as the control. Household surveys will be conducted at baseline and endline to assess (1) household milk production and the sustainability of adoption of GHP routines, (2) the relationship of household milk production to child milk consumption, (3) household factors influencing child milk consumption (participation in nutrition education, mother's education, socioeconomic status, etc.), and (4) longitudinal child growth and development. In addition, a pilot study will determine if households can accurately record milk production and child milk intake. The project is designed to enhance understanding of the links between milk availability and child milk consumption in rural Nepal. It aims to explore whether milk consumption is limited by availability or other factors (nutrition awareness, socioeconomic status, maternal education). Additionally, the investigators will examine if optimization of milk consumption by young children can further boost their growth and development, and whether instruction in good animal husbandry practice and mastitis control is sustainable. These findings could more appropriately and efficiently direct resources to improve child nutrition and development and household dairy practices.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

March 13, 2019

Last Update Submit

May 20, 2022

Conditions

Keywords

NepalASF consumption

Outcome Measures

Primary Outcomes (7)

  • Change in child height from baseline to midline

    Height of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.

    baseline, midline (0, 6 months)

  • Change in child height from baseline to endline

    Height of children will be measured, and converted to z scores. The difference from baseline to endline will be assessed.

    baseline, endline (0, 12 months)

  • Change in child weight from baseline to midline

    Weight of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.

    baseline, midline (0, 6 months)

  • Change in child weight from baseline to endline

    Weight of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.

    baseline, endline (0, 12 months)

  • Change in child head circumference from baseline to midline

    Head circumference will be measured, and converted to z scores

    baseline, midline (0, 6 months)

  • Change in child head circumference from baseline to endline

    Head circumference will be measured, and converted to z scores

    baseline, endline (0, 12 months)

  • Change in child development standardized score from baseline to endline

    Developmental performance on standardized test, the Ages and Stages Questionnaire. The change in scores from baseline to endline will be assessed.

    baseline and endline (0, 12 months)

Secondary Outcomes (1)

  • Milk consumption by children

    daily for up to 365 days

Study Arms (2)

Nutrition Education

ACTIVE COMPARATOR

Households will participate in community-based nutrition education program specifically targeting child nutrition and milk consumption, in addition to general community development activities

Other: Community-based nutrition education

Control

NO INTERVENTION

community development activities only.

Interventions

Nutrition education will be included in community development training. The nutrition education will target child nutrition, particularly consumption of animal-source foods and especially milk. The importance of dietary diversity will also be emphasized. Demonstrations of food preparation techniques will also be included in the training.

Nutrition Education

Eligibility Criteria

Age6 Months - 66 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • months of age, parent willing to participate in research activity

You may not qualify if:

  • unwillingness to participate in the research activity, plans to leave the area within the next 12 months, or child with physical or other special needs that prevent the ingestion of a normal diet-for-age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valley Research Group

Kathmandu, Nepal

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Shailes Neupane, M.S.

    Valley Research Group

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Household clusters (separated geographically) will be randomly assigned to receive either nutrition education or to control status (no education).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 22, 2019

Study Start

November 1, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations