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Enhancing Milk Consumption by Vulnerable Household Members in Rural Nepal

Primary Purpose

Undernutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Nutrition Education
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Undernutrition

Eligibility Criteria

6 Months - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Heifer Project International Nepal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Nutrition Education

Control

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Number of Animal Source Foods Consumed in prior 24 hours (diet recall survey), baseline to endline
Impact of nutrition education on diet of mothers, children 6-60 months, and adolescent girls will compared between baseline and endline.

Secondary Outcome Measures

Change in height-for-age z score from baseline to endline for children 6-60 months
Child height in centimeters will be measured at baseline and endline. Results will be converted to z scores using World Health Organization standards. Changes in height-for-age z score between baseline and endline will be compared, and related to child consumption of animal source foods.
Change in head circumference-for-age z score from baseline to endline for children 6-60 months
Child head circumference in centimeters will be measured at baseline and endline. Results will be converted to z scores using World Health Organization standards. Changes in head circumference-for-age z score between baseline and endline will be compared, and related to child consumption of animal source foods.
Change in BMI from baseline to endline for adolescent girls
Height in centimeters and weight in kilograms will be measured in adolescent girls 10-15 years of age at baseline and endline. Results will be converted to BMI (kg/m^2) using World Health Organization standards. Changes in BMI between baseline and endline will be compared, and related to adolescent consumption of animal source foods.

Full Information

First Posted
May 21, 2022
Last Updated
August 30, 2022
Sponsor
Tufts University
Collaborators
Heifer Project International
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1. Study Identification

Unique Protocol Identification Number
NCT05525429
Brief Title
Enhancing Milk Consumption by Vulnerable Household Members in Rural Nepal
Official Title
Integrated Approach to Enhance Milk Consumption by Vulnerable Household Members in Rural Nepal
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Heifer Project International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 characterize these barriers in detail 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Education
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education
Intervention Description
Multidimensional nutrition education will be provided.
Primary Outcome Measure Information:
Title
Number of Animal Source Foods Consumed in prior 24 hours (diet recall survey), baseline to endline
Description
Impact of nutrition education on diet of mothers, children 6-60 months, and adolescent girls will compared between baseline and endline.
Time Frame
~1 year
Secondary Outcome Measure Information:
Title
Change in height-for-age z score from baseline to endline for children 6-60 months
Description
Child height in centimeters will be measured at baseline and endline. Results will be converted to z scores using World Health Organization standards. Changes in height-for-age z score between baseline and endline will be compared, and related to child consumption of animal source foods.
Time Frame
~1 year
Title
Change in head circumference-for-age z score from baseline to endline for children 6-60 months
Description
Child head circumference in centimeters will be measured at baseline and endline. Results will be converted to z scores using World Health Organization standards. Changes in head circumference-for-age z score between baseline and endline will be compared, and related to child consumption of animal source foods.
Time Frame
~1 year
Title
Change in BMI from baseline to endline for adolescent girls
Description
Height in centimeters and weight in kilograms will be measured in adolescent girls 10-15 years of age at baseline and endline. Results will be converted to BMI (kg/m^2) using World Health Organization standards. Changes in BMI between baseline and endline will be compared, and related to adolescent consumption of animal source foods.
Time Frame
~1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie Miller
Phone
+33612222628
Email
laurie.miller@tufts.edu
Facility Information:
Facility Name
Heifer Project International Nepal
City
Kathmandu
Country
Nepal

12. IPD Sharing Statement

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Enhancing Milk Consumption by Vulnerable Household Members in Rural Nepal

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