NCT03926689

Brief Summary

Eggs are well-known to be a balanced source of protein, energy, fatty acids, and micronutrients and increasingly identified as an opportunity to improve nutrition of poor populations. Few implementation studies have been done globally, and none in South Asia, to assess the effectiveness of using behavior change programs to motivate households to increase egg consumption. Egg consumption is particularly poor in Nepal, but the government and development partners are implementing at scale policies and programs to address poor diets and other determinants of undernutrition, which is persistently high in Nepal. This cluster-randomized controlled trial (c-RCT) aims to help address the gap in the evidence base regarding how to improve egg consumption. The c-RCT will evaluate the effectiveness of using short message service (SMS) messaging, layered into a large-scale behavior change program, to improve egg consumption and dietary diversity among children 1 to 2 years of age. A two-arm trial will be used to compare the following two strategies: 1) Suaahara II standard multi-sectoral nutrition interventions without any text messages and 2) Suaahara II standard multi sectoral nutrition interventions plus a SMS message campaign targeting all adult household members of households in the 1000-day period between conception and a child's second birthday.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 20, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

March 8, 2019

Last Update Submit

April 13, 2022

Conditions

Dietary Habits

Keywords

egg consumptiondietary diversitycomplementary feedingSouth AsiaSMS

Outcome Measures

Primary Outcomes (2)

  • Child egg consumption

    Change in prevalence of any egg consumption in 24 hours prior to survey among children 12 to 23 months of age.

    baseline and 12 months later

  • Child minimum dietary diversity

    Change in prevalence of obtaining minimum dietary diversity score (at least four of seven food groups) in previous 24 hours for children aged 12-23 months of age

    baseline and 12 months later

Secondary Outcomes (9)

  • Child dietary diversity score

    baseline and 12 months later

  • Adult caregiver egg consumption

    baseline and 12 months later

  • Adult minimum dietary diversity

    baseline and 12 months later

  • Adult dietary diversity score

    baseline and 12 months later

  • Infant and Young Child Feeding knowledge

    baseline and 12 months later

  • +4 more secondary outcomes

Study Arms (2)

Suaahara II Standard + SMS

EXPERIMENTAL

Suaahara II standard multi sectoral nutrition interventions (home visits, radio program, etc.) Suaahara II monthly SMS campaign targeting all adult household members of households in the 1000-day period between conception and a child's second birthday

Behavioral: SMS messagesBehavioral: Standard SII SBCC

Suaahara II Standard

ACTIVE COMPARATOR

Suaahara II standard multi sectoral nutrition interventions (home visits, radio program, etc.)

Behavioral: Standard SII SBCC

Interventions

SMS messagesBEHAVIORAL

A package of at least monthly SMS messages delivered to all adults in households with an individual in the 1000-day period between pregnancy and a child turning 2 years of age.

Suaahara II Standard + SMS
Standard SII SBCCBEHAVIORAL

Home visits/IPC; community events including food demo and key life events; and Bhanchhin Aama radio program episodes

Suaahara II StandardSuaahara II Standard + SMS

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • household must have resided in the study cluster for the previous 12 months;
  • household must have at least 1 child 12-23 completed months of age who was not acutely ill the previous day and does not have a disability preventing normal feeding; if a household has more than one child aged 12-23 months, but the children have different mothers, each mother is an eligible trial participant
  • household must have at least one adult (18 years or older) residing in the household and owning a mobile phone

You may not qualify if:

  • a few clusters will be excluded from the study given their lack of representation of the overall study area (e.g., 2 clusters with less than 150 households which are all landless and without government resources; 1 cluster which is exclusively a Tamang population; and 1 cluster which is the main urban area)
  • in the rare occurrence that in an eligible household, a mother has more than one child aged 12-23.9 months, then the youngest will be chosen in the trial and the other child excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suaahara II/Helen Keller International, Nepal

Patan, Nepal

Location

Related Publications (21)

  • Adhikari TB, Rijal A. E-mental health - An untapped opportunity in Nepal. Asian J Psychiatr. 2018 Dec;38:25-26. doi: 10.1016/j.ajp.2018.10.021. Epub 2018 Oct 23. No abstract available.

    PMID: 30384225BACKGROUND

  • Barnett, I., Scott, N., Batchelor, S., Haddad, L., 2016. Dial "N" for nutrition? A Landscape Analysis of What We Know about m-Nutrition, m-Agriculture and m-Development.

    BACKGROUND

  • Campbell RK, Talegawkar SA, Christian P, LeClerq SC, Khatry SK, Wu LS, West KP Jr. Seasonal dietary intakes and socioeconomic status among women in the Terai of Nepal. J Health Popul Nutr. 2014 Jun;32(2):198-216.

    PMID: 25076658BACKGROUND

  • Cunningham, K., Headey, D., Singh, A., Karmacharya, C., Rana, P.P., 2017. Maternal and Child Nutrition in Nepal: Examining drivers of progress from the mid-1990s to 2010s. Glob. Food Sec. 13, 30-37. https://doi.org/10.1016/j.gfs.2017.02.001

    BACKGROUND

  • Cunningham K, Singh A, Pandey Rana P, Brye L, Alayon S, Lapping K, Gautam B, Underwood C, Klemm RDW. Suaahara in Nepal: An at-scale, multi-sectoral nutrition program influences knowledge and practices while enhancing equity. Matern Child Nutr. 2017 Oct;13(4):e12415. doi: 10.1111/mcn.12415. Epub 2017 Jan 6.

    PMID: 28058772BACKGROUND

  • Dulal B, Mundy G, Sawal R, Rana PP, Cunningham K. Homestead Food Production and Maternal and Child Dietary Diversity in Nepal: Variations in Association by Season and Agroecological Zone. Food Nutr Bull. 2017 Sep;38(3):338-353. doi: 10.1177/0379572117703264. Epub 2017 Apr 21.

    PMID: 28429645BACKGROUND

  • Dumas SE, Lewis D, Travis AJ. Small-scale egg production centres increase children's egg consumption in rural Zambia. Matern Child Nutr. 2018 Oct;14 Suppl 3(Suppl 3):e12662. doi: 10.1111/mcn.12662.

    PMID: 30332540BACKGROUND

  • FAO and FHI 360, 2016. Minimum Dietary Diversity for Women: A guide for measurement. http://www.fao.org/3/a-i5486e.pdf

    BACKGROUND

  • Gallegos-Riofrio CA, Waters WF, Salvador JM, Carrasco AM, Lutter CK, Stewart CP, Iannotti LL. The Lulun Project's social marketing strategy in a trial to introduce eggs during complementary feeding in Ecuador. Matern Child Nutr. 2018 Oct;14 Suppl 3(Suppl 3):e12700. doi: 10.1111/mcn.12700.

    PMID: 30332535BACKGROUND

  • Houston, R., Shresha, M.B., Pomeroy, A., Wun, J., Sharma, I., 2014. Pathways To Better Nutrition Case Study: Nepal Strategic Background Report. Arlington, VA. https://www.popline.org/node/635850

    BACKGROUND

  • Lutter CK, Morris SS. Eggs: A high potential food for improving maternal and child nutrition. Matern Child Nutr. 2018 Oct;14 Suppl 3(Suppl 3):e12666. doi: 10.1111/mcn.12666. No abstract available.

    PMID: 30332541BACKGROUND

  • Mildon, A., 2016. Use of Mobile Phone Technology to Support Improved Infant and Young Child Feeding Practices in Low-and Middle-income Countries: A Scoping Review. Univ. Toronto. University of Toronto. https://tspace.library.utoronto.ca/bitstream/.../Mildon_Alison_201611_MSc_thesis.pdf

    BACKGROUND

  • Ministry of Health 2017. Nepal Demographic and Health Survey 2016. Kathmandu.

    BACKGROUND

  • Morris SS, Beesabathuni K, Headey D. An egg for everyone: Pathways to universal access to one of nature's most nutritious foods. Matern Child Nutr. 2018 Oct;14 Suppl 3(Suppl 3):e12679. doi: 10.1111/mcn.12679.

    PMID: 30332534BACKGROUND

  • Orton M, Agarwal S, Muhoza P, Vasudevan L, Vu A. Strengthening Delivery of Health Services Using Digital Devices. Glob Health Sci Pract. 2018 Oct 10;6(Suppl 1):S61-S71. doi: 10.9745/GHSP-D-18-00229. Print 2018 Oct 10.

    PMID: 30305340BACKGROUND

  • Parajuli, J., Haynes, K.E., 2018. Cellular mobile telephony in Nepal. Lett. Spat. Resour. Sci. 11, 209-222. https://doi.org/10.1007/s12076-018-0212-7

    BACKGROUND

  • Singh A, Klemm RDW, Mundy G, Pandey Rana P, Pun B, Cunningham K. Improving maternal, infant and young child nutrition in Nepal via peer mobilization. Public Health Nutr. 2018 Mar;21(4):796-806. doi: 10.1017/S1368980017002993. Epub 2017 Nov 6.

    PMID: 29103400BACKGROUND

  • Tilahun B, Smillie K, Bardosh KL, Murray M, Fitzgerald M, Cook V, Poureslami I, Forrest J, Lester R. Identifying Barriers and Facilitators of 13 mHealth Projects in North America and Africa: Protocol for a 5-Year Implementation Science Study. JMIR Res Protoc. 2018 Jul 3;7(7):e162. doi: 10.2196/resprot.9633.

    PMID: 29970360BACKGROUND

  • World Health Organization, 2010. Indicators for assessing infant and young child feeding practices: part 1 definitions. Geneva.

    BACKGROUND

  • Cunningham K, Cech S, Gupta AS, Rana PP, Humphries D, Frongillo EA. Text messages to improve young child diets: Results from a cluster-randomized controlled trial in Kanchanpur, Nepal. Matern Child Nutr. 2026 Mar;22(1):e13702. doi: 10.1111/mcn.13702. Epub 2024 Jul 17.

    PMID: 39016667DERIVED

  • Cunningham K, Pandey Rana P, Rahman MM, Sen Gupta A, Manandhar S, Frongillo EA. Text messages to improve child diets: Formative research findings and protocol of a randomised controlled trial in Nepal. Matern Child Nutr. 2023 Jul;19(3):e13490. doi: 10.1111/mcn.13490. Epub 2023 Mar 2.

    PMID: 36864635DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Ed Frongillo

    University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Aman Sen

    Helen Keller International

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2019

First Posted

April 24, 2019

Study Start

August 20, 2019

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

NE(1)