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Strategies to Increase Milk Consumption by Young Nepali Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886467
Recruitment Status : Enrolling by invitation
First Posted : March 22, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Laurie Miller, MD, Tufts University

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.


Condition or disease Intervention/treatment Phase
Child Malnutrition Other: Community-based nutrition education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Household clusters (separated geographically) will be randomly assigned to receive either nutrition education or to control status (no education).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Strategies to Increase Milk Consumption by Young Nepali Children
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Child Nutrition

Arm Intervention/treatment
Active Comparator: Nutrition Education
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
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.

No Intervention: Control
community development activities only.



Primary Outcome Measures :
  1. Change in child height from baseline to midline [ Time Frame: baseline, midline (0, 6 months) ]
    Height of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.

  2. Change in child height from baseline to endline [ Time Frame: baseline, endline (0, 12 months) ]
    Height of children will be measured, and converted to z scores. The difference from baseline to endline will be assessed.

  3. Change in child weight from baseline to midline [ Time Frame: baseline, midline (0, 6 months) ]
    Weight of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.

  4. Change in child weight from baseline to endline [ Time Frame: baseline, endline (0, 12 months) ]
    Weight of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.

  5. Change in child head circumference from baseline to midline [ Time Frame: baseline, midline (0, 6 months) ]
    Head circumference will be measured, and converted to z scores

  6. Change in child head circumference from baseline to endline [ Time Frame: baseline, endline (0, 12 months) ]
    Head circumference will be measured, and converted to z scores

  7. Change in child development standardized score from baseline to endline [ Time Frame: baseline and endline (0, 12 months) ]
    Developmental performance on standardized test, the Ages and Stages Questionnaire. The change in scores from baseline to endline will be assessed.


Secondary Outcome Measures :
  1. Milk consumption by children [ Time Frame: daily for up to 365 days ]
    Amount of milk consumed by children will be measured daily, using standardized measuring cups. The information will be recorded by their mothers. The daily consumption will be compiled into monthly total consumption for later analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 66 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6-66 months of age, parent willing to participate in research activity

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886467


Locations
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Nepal
Valley Research Group
Kathmandu, Nepal
Sponsors and Collaborators
Tufts University
Investigators
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Study Director: Shailes Neupane, M.S. Valley Research Group

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Responsible Party: Laurie Miller, MD, Professor of Pediatrics, Tufts University
ClinicalTrials.gov Identifier: NCT03886467    
Other Study ID Numbers: STRATEGIES
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurie Miller, MD, Tufts University:
Nepal
ASF consumption
Additional relevant MeSH terms:
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Malnutrition
Child Nutrition Disorders
Nutrition Disorders