Dietary HabitsNCT03926689
SMS Messages to Increase Child Egg Consumption, a C-rct in Nepal
A study testing SMS messages and Standard SII SBCC in people with Dietary Habits, run by Helen Keller International at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- SMS messages and Standard SII SBCC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,301 participants
- Where
- 1 siteNepal
- Study dates
- 20 Aug 2019to 28 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- household must be able and willing to register the phone number for the intervention and consent to inclusion in the survey for the trial.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of Sending SMS Messages to Increase Egg Consumption Among Children One 1-2 Years of Age, a Cluster-randomized Controlled Trial in Kanchanpur, Nepal
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.
Read the detailed description
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. A recent trial in Ecuador showed dramatic improvements in child growth after consumption of eggs for only six months. This efficacy trial also showed that culturally appropriate strategies, taking local norms, values, and expectations into account, are important. Furthermore, small-scale egg production has proven to be an effective intervention to increase egg consumption among children. 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.
Despite significant reductions in under-nutrition over the last several decades, Nepal persists as a nation with one of the highest prevalence of child undernutrition globally. There is substantial room for improvement in important nutrition-related behaviors, including poor diets. According to the 2016 Nepal Demographic and Health Survey (DHS), only about one-third of children 6 to 23 months of age receive a minimum acceptable diet, less than half (47%) eat foods from at least 4 of 7 food groups to attain minimum dietary diversity (DD), and not even 10% consume eggs. The Government of Nepal (GoN) and development partners have prioritized multi-sectoral (integrated) nutrition as a key development agenda. Suaahara II, a USAID-funded program (2016-2021), aims to reduce under-nutrition particularly among women and children in the 1000-day period between conception and a child's second birthday, a crucial window of opportunity during which interventions have optimal impact on child growth and development. Operational in 42 of Nepal's 77 districts, Suaahara II uses a district-wide approach and interventions cover nutrition, health, family planning, agriculture, governance, gender equality, and social inclusion.
Suaahara II's social and behavioral change communication (SBCC) interventions, using lessons learned from the first phase of Suaahara, prioritize 10 key behaviors for which knowledge-to-practice gaps persisted at the end of Suaahara I. Two of these 10 behaviors focus on dietary diversity: 1) mothers should eat a diverse diet, including eggs and meat, and 2) young children should eat a diverse diet, including eggs and meat. Suaahara II's SBCC approach includes a combination of interpersonal communication (IPC) (e.g., home visits for 1:1 counselling with Suaahara II frontline workers); community mobilization (e.g., health mothers group meetings; food demonstrations and key life event celebrations); mass media (i.e., an interactive weekly radio program known as Bhanchhin Aama); and as of 2018, a series of 35 SMS messages sent to 1000-day households (other than those residing in Kanchanpur, the trial district) to reinforce the promoted 10 key behaviors as well as regular contact with the health system.
The SMS messages started after monitoring data showed that over 95% of beneficiary households own a phone, including more than two-thirds of mothers. Each message is sent at a specific time to align with key times when a key nutrition-related health service contact point or important nutrition-related practice is needed during the 1000-day period (e.g., a reminder to go for antenatal care; an encouragement to continue exclusive breastfeeding for another two months when the child is 4 months). In pre-testing of this intervention in 2 districts with 1000-day mothers, Suaahara II found acceptability and interest to be high and a preference for text over voice messages as mothers noted that they can keep the former as record and messages were read when they had time providing them with flexibility; messaging could be as often as weekly; and mothers showed the messages to others and discussed about the content, even though not prompted to do so. The cost of sending SMS messages in Nepal is also lower than other behavior change methods which include costs for staff, travel, jobaids, and so on. For these reasons, SMS push-messaging has potential to be an effective tool for behavior change. Evidence of intervention effectiveness is lacking, however, and is particularly needed in Nepal where the Ministry of Health and Population is prioritizing the use of SMS push messages as part of their SBCC strategy for implementation of the Multi-sectoral Nutrition Plan.
While SMS messaging is promising, various mHealth, and more recently mNutrition, literature reviews have noted the lack of rigorous research designs to assess effectiveness of these interventions. Some mHealth studies have shown positive results; for example, in Zanzibar a trial showed that mobile messaging can improve antenatal care attendance. These studies are few, and mNutrition studies even fewer. To the investigator's knowledge, no studies have assessed the effectiveness of using mNutrition interventions to improve diets in South Asia. Recent formative research in Sri Lanka, however, suggests the potential effectiveness of using mobile phones to improve infant and young child feeding.
Growing mobile phone ownership in Nepal offers a potential mechanism for delivering nutrition messages to target groups in a time-saving and cost-effective way. While not everyone currently owns a phone, ownership is increasing even among quite remote populations. Given the combination of poor dietary diversity, limited reach of the health system, and having one of the fastest growing rates of mobile phone ownership among low- and middle-income countries, Nepal is an ideal setting for testing the use of SMS messages to promote ideal dietary practices.
This study aims to use the rigor of a randomized controlled trial (RCT) to address a gap in the evidence base regarding the effectiveness of using short message service (SMS) text messaging to improve dietary practices. The main research question is: are SMS messages, added to a large-scale behavior change program, an effective means of improving diets among children under 2 years of age? To assess the comparative effectiveness of delivering nutrition-related SMS messages, 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 text message campaign targeting all adult household members of households in the 1000-day period between conception and a child's second birthday.
The c-RCT will involve a baseline survey in April/May 2019 and an endline survey in Nov-Jan 2021 (delayed due to covid-19, as originally planned data collection in April/May 2020 was not possible). The design is longitudinal at the cluster level but not at the household or individual level to be able to assess households with children aged 12-23 months at both baseline and endline. An SMS message intervention will begin in the trial district (Kanchanpur) only after data collection for the baseline has completed and will involve sending monthly text messages primarily about egg consumption and dietary diversity. About 4 months after the implementation starts, a mixed-methods process evaluation will be conducted to assess fidelity of program implementation and identify any challenges or bottlenecks to be addressed.
- Conditions
- Dietary Habits
- Being tested
- SMS messages, Standard SII SBCC
- Keywords
- egg consumption, dietary diversity, complementary feeding, South Asia, SMS
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS messagesBehavioural
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.
Standard SII SBCCBehavioural
Home visits/IPC; community events including food demo and key life events; and Bhanchhin Aama radio program episodes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: SMS messages; Behavioral: Standard SII SBCC |
| Suaahara II Standard | Active comparator | Suaahara II standard multi sectoral nutrition interventions (home visits, radio program, etc.) Receives: Behavioral: Standard SII SBCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child egg consumption
Change in prevalence of any egg consumption in 24 hours prior to survey among children 12 to 23 months of age.
Measured: 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
Measured: baseline and 12 months later
Secondary outcomes (9)
Child dietary diversity score
Change in mean dietary diversity (range:0 lowest - 7 highest) in previous 24 hours for children 12 to 23 months of age
Measured: baseline and 12 months later
Adult caregiver egg consumption
Change in prevalence of any egg consumption in previous 24 hours among adults residing in a household with a child 12 to 23 months of age
Measured: baseline and 12 months later
Adult minimum dietary diversity
Change in prevalence of obtaining minimum dietary diversity score (at least five of ten food groups) in previous 24 hours among adults residing in a household with a child 12 to 23 months of age
Measured: baseline and 12 months later
Adult dietary diversity score
Change in mean dietary diversity (range:0 lowest -10 highest) in previous 24 hours for adults residing in a household with a child 12 to 23 months of age
Measured: baseline and 12 months later
Infant and Young Child Feeding knowledge
Change in mean knowledge score (range: 0-8) on core infant and young child feeding practices among adults residing in a household with a child 12 to 23 months of age
Measured: baseline and 12 months later
Health Mothers' Groups participation
Change in prevalence of any participation in the last 3 months in a Female Community Health Volunteer-led group, by the mother of the survey child 12-23 months of age
Measured: baseline and 12 months later
Health Mothers' Groups participation frequency
Change in number of times participated in the last 3 months in an Female Community Health Volunteer-led group by the mother of the survey child 12-23 months of age
Measured: baseline and 12 months later
Adult Bhanchhin Aama listenership
Change in prevalence of any listenership in the last 3 months to Bhanchhin Aama, Suaahara II radio program, in the previous three months by any adult household member
Measured: baseline and 12 months later
Adult Bhanchhin Aama listenership frequency
Change in number of times listened to Bhanchhin Aama, Suaahara II radio program, in the previous three months by any adult household member
Measured: baseline and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start20 Aug 2019
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Keller International
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, University College, London, International Food Policy Research Institute, FHI 360, London School of Hygiene and Tropical Medicine, United States Agency for International Development (USAID), Digital Broadcast Initiative Equal Access
- Responsible party
- Sponsor
- Investigators
- Ed Frongillo, Principal investigator, University of South CarolinaAman Sen, Study chair, Helen Keller International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926689
- Sponsor's protocol ID
- SIIegg2019-2020
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30384225Barnett, 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.
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.
PubMed 25076658Cunningham, 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
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.
PubMed 28058772Dulal 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.
PubMed 28429645Dumas 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.
PubMed 30332540FAO and FHI 360, 2016. Minimum Dietary Diversity for Women: A guide for measurement. http://www.fao.org/3/a-i5486e.pdf
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.
PubMed 30332535Houston, 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
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.
PubMed 30332541Mildon, 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
Ministry of Health 2017. Nepal Demographic and Health Survey 2016. Kathmandu.
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.
PubMed 30332534Orton 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.
PubMed 30305340
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Sending SMS Messages to Increase Egg Consumption Among Children One 1-2 Years of Age, a Cluster-randomized Controlled Trial in Kanchanpur, Nepal
- ClinicalTrials.gov ID
- NCT03926689
- Acronym / sponsor ID
- SIIegg2019-2020
- Conditions
- Dietary Habits
- Keywords
- egg consumption, dietary diversity, complementary feeding, South Asia, SMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,301 participants (actual)
- Lead sponsor
- Helen Keller InternationalUniversity, hospital or other
- Collaborators
- University of South Carolina, University College, London, International Food Policy Research Institute, FHI 360, London School of Hygiene and Tropical Medicine, United States Agency for International Development (USAID), Digital Broadcast Initiative Equal Access
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. A recent trial in Ecuador showed dramatic improvements in child growth after consumption of eggs for only six months. This efficacy trial also showed that culturally appropriate strategies, taking local norms, values, and expectations into account, are important. Furthermore, small-scale egg production has proven to be an effective intervention to increase egg consumption among children. 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.
Despite significant reductions in under-nutrition over the last several decades, Nepal persists as a nation with one of the highest prevalence of child undernutrition globally. There is substantial room for improvement in important nutrition-related behaviors, including poor diets. According to the 2016 Nepal Demographic and Health Survey (DHS), only about one-third of children 6 to 23 months of age receive a minimum acceptable diet, less than half (47%) eat foods from at least 4 of 7 food groups to attain minimum dietary diversity (DD), and not even 10% consume eggs. The Government of Nepal (GoN) and development partners have prioritized multi-sectoral (integrated) nutrition as a key development agenda. Suaahara II, a USAID-funded program (2016-2021), aims to reduce under-nutrition particularly among women and children in the 1000-day period between conception and a child's second birthday, a crucial window of opportunity during which interventions have optimal impact on child growth and development. Operational in 42 of Nepal's 77 districts, Suaahara II uses a district-wide approach and interventions cover nutrition, health, family planning, agriculture, governance, gender equality, and social inclusion.
Suaahara II's social and behavioral change communication (SBCC) interventions, using lessons learned from the first phase of Suaahara, prioritize 10 key behaviors for which knowledge-to-practice gaps persisted at the end of Suaahara I. Two of these 10 behaviors focus on dietary diversity: 1) mothers should eat a diverse diet, including eggs and meat, and 2) young children should eat a diverse diet, including eggs and meat. Suaahara II's SBCC approach includes a combination of interpersonal communication (IPC) (e.g., home visits for 1:1 counselling with Suaahara II frontline workers); community mobilization (e.g., health mothers group meetings; food demonstrations and key life event celebrations); mass media (i.e., an interactive weekly radio program known as Bhanchhin Aama); and as of 2018, a series of 35 SMS messages sent to 1000-day households (other than those residing in Kanchanpur, the trial district) to reinforce the promoted 10 key behaviors as well as regular contact with the health system.
The SMS messages started after monitoring data showed that over 95% of beneficiary households own a phone, including more than two-thirds of mothers. Each message is sent at a specific time to align with key times when a key nutrition-related health service contact point or important nutrition-related practice is needed during the 1000-day period (e.g., a reminder to go for antenatal care; an encouragement to continue exclusive breastfeeding for another two months when the child is 4 months). In pre-testing of this intervention in 2 districts with 1000-day mothers, Suaahara II found acceptability and interest to be high and a preference for text over voice messages as mothers noted that they can keep the former as record and messages were read when they had time providing them with flexibility; messaging could be as often as weekly; and mothers showed the messages to others and discussed about the content, even though not prompted to do so. The cost of sending SMS messages in Nepal is also lower than other behavior change methods which include costs for staff, travel, jobaids, and so on. For these reasons, SMS push-messaging has potential to be an effective tool for behavior change. Evidence of intervention effectiveness is lacking, however, and is particularly needed in Nepal where the Ministry of Health and Population is prioritizing the use of SMS push messages as part of their SBCC strategy for implementation of the Multi-sectoral Nutrition Plan.
While SMS messaging is promising, various mHealth, and more recently mNutrition, literature reviews have noted the lack of rigorous research designs to assess effectiveness of these interventions. Some mHealth studies have shown positive results; for example, in Zanzibar a trial showed that mobile messaging can improve antenatal care attendance. These studies are few, and mNutrition studies even fewer. To the investigator's knowledge, no studies have assessed the effectiveness of using mNutrition interventions to improve diets in South Asia. Recent formative research in Sri Lanka, however, suggests the potential effectiveness of using mobile phones to improve infant and young child feeding.
Growing mobile phone ownership in Nepal offers a potential mechanism for delivering nutrition messages to target groups in a time-saving and cost-effective way. While not everyone currently owns a phone, ownership is increasing even among quite remote populations. Given the combination of poor dietary diversity, limited reach of the health system, and having one of the fastest growing rates of mobile phone ownership among low- and middle-income countries, Nepal is an ideal setting for testing the use of SMS messages to promote ideal dietary practices.
This study aims to use the rigor of a randomized controlled trial (RCT) to address a gap in the evidence base regarding the effectiveness of using short message service (SMS) text messaging to improve dietary practices. The main research question is: are SMS messages, added to a large-scale behavior change program, an effective means of improving diets among children under 2 years of age? To assess the comparative effectiveness of delivering nutrition-related SMS messages, 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 text message campaign targeting all adult household members of households in the 1000-day period between conception and a child's second birthday.
The c-RCT will involve a baseline survey in April/May 2019 and an endline survey in Nov-Jan 2021 (delayed due to covid-19, as originally planned data collection in April/May 2020 was not possible). The design is longitudinal at the cluster level but not at the household or individual level to be able to assess households with children aged 12-23 months at both baseline and endline. An SMS message intervention will begin in the trial district (Kanchanpur) only after data collection for the baseline has completed and will involve sending monthly text messages primarily about egg consumption and dietary diversity. About 4 months after the implementation starts, a mixed-methods process evaluation will be conducted to assess fidelity of program implementation and identify any challenges or bottlenecks to be addressed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suaahara II Standard + SMS | Experimental | Behavioral: SMS messages, Behavioral: Standard SII SBCCSuaahara 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 |
| Suaahara II Standard | Active comparator | Behavioral: Standard SII SBCCSuaahara II standard multi sectoral nutrition interventions (home visits, radio program, etc.) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- household must be able and willing to register the phone number for the intervention and consent to inclusion in the survey for the trial.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS messagesA 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. | Behavioural | Suaahara II Standard + SMS |
| Standard SII SBCCHome visits/IPC; community events including food demo and key life events; and Bhanchhin Aama radio program episodes | Behavioural | Suaahara II Standard, Suaahara II Standard + SMS |
Primary outcome
Child egg consumption
Time frame: baseline and 12 months later
Change in prevalence of any egg consumption in 24 hours prior to survey among children 12 to 23 months of age.
Child minimum dietary diversity
Time frame: baseline and 12 months later
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
9 secondary outcomes
Child dietary diversity score
Time frame: baseline and 12 months later
Adult caregiver egg consumption
Time frame: baseline and 12 months later
Adult minimum dietary diversity
Time frame: baseline and 12 months later
Adult dietary diversity score
Time frame: baseline and 12 months later
Infant and Young Child Feeding knowledge
Time frame: baseline and 12 months later
Health Mothers' Groups participation
Time frame: baseline and 12 months later
Health Mothers' Groups participation frequency
Time frame: baseline and 12 months later
Adult Bhanchhin Aama listenership
Time frame: baseline and 12 months later
Adult Bhanchhin Aama listenership frequency
Time frame: baseline and 12 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 30384225Adhikari 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.
- BackgroundBarnett, 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: PubMed 25076658Campbell 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.
- BackgroundCunningham, 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: PubMed 28058772Cunningham 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.
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- Background: PubMed 30332540Dumas 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.
- BackgroundFAO and FHI 360, 2016. Minimum Dietary Diversity for Women: A guide for measurement. http://www.fao.org/3/a-i5486e.pdf
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- BackgroundMildon, 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
- Individual participant dataSharing planned: Undecided
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Nutrition for Precision Health, Powered by the All of Us
Nutrition, Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed Frongillo principal investigator
University of South Carolina
Aman Sen study chair
Helen Keller International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS messages and Standard SII SBCC in people with Dietary Habits, run by Helen Keller International at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child egg consumption (time frame: baseline and 12 months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03926689, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.