Clinical trial NCT03926689: SMS Messages to Increase Child Egg Consumption, a C-rct in Nepal
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Keywords: egg consumption
dietary diversity
complementary feeding
South Asia
SMS
Lead sponsor: Helen Keller International
Sponsor class: OTHER
Collaborators: name: University of South Carolina
name: University College, London
name: International Food Policy Research Institute
name: FHI 360
name: London School of Hygiene and Tropical Medicine
name: United States Agency for International Development (USAID)
name: Digital Broadcast Initiative Equal Access
First posted: 2019-04-24
Enrollment: 3301
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Child egg consumption
timeFrame: baseline and 12 months later
measure: Child minimum dietary diversity
timeFrame: baseline and 12 months later
Secondary outcomes:
measure: Child dietary diversity score
timeFrame: baseline and 12 months later
measure: Adult caregiver egg consumption
timeFrame: baseline and 12 months later
measure: Adult minimum dietary diversity
timeFrame: baseline and 12 months later
measure: Adult dietary diversity score
timeFrame: baseline and 12 months later
measure: Infant and Young Child Feeding knowledge
timeFrame: baseline and 12 months later
measure: Health Mothers' Groups participation
timeFrame: baseline and 12 months later
measure: Health Mothers' Groups participation frequency
timeFrame: baseline and 12 months later
measure: Adult Bhanchhin Aama listenership
timeFrame: baseline and 12 months later
measure: Adult Bhanchhin Aama listenership frequency
timeFrame: baseline and 12 months later
Other outcomes:
Locations:
city: Patan
country: Nepal
facility: Suaahara II/Helen Keller International, Nepal
Study officials:
affiliation: University of South Carolina
name: Ed Frongillo
role: PRINCIPAL_INVESTIGATOR
affiliation: Helen Keller International
name: Aman Sen
role: STUDY_CHAIR
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