[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630907":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":52,"studyPopulation":42,"armGroups":53,"interventions":70,"overallOfficials":42,"centralContacts":78,"locations":88,"responsibleParty":108,"collaborators":112,"id":115,"slug":42,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":42,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":136,"whyStopped":42,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Harvard School of Public Health (HSPH)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Anemia prevalence","Anemia prevalence at 9 months post-baseline, defined using WHO age- and sex-specific hemoglobin cutoffs:\n\n* Boys aged ≥15 years: hemoglobin \\\u003C13.0 g\u002FdL.\n* Girls aged ≥15 years: hemoglobin \\\u003C12.0 g\u002FdL.\n* Hemoglobin will be measured at baseline, 4 months, and 9 months using finger-prick capillary blood samples and point-of-care devices (e.g., HemoCue hemoglobinometer or equivalent).","Baseline, at 4 months and 9 months after baseline",[14,18,22,26,30,33,36,39],{"measure":15,"description":16,"timeFrame":17},"Moderate and severe anemia","Moderate and severe anemia at 9 months:\n\nBoys aged ≥15 years:\n\nModerate anemia: 8.0-10.9 g\u002FdL. Severe anemia: \\\u003C8.0 g\u002FdL.\n\nGirls aged ≥15 years:\n\nModerate anemia: 7.0-10.9 g\u002FdL. Severe anemia: \\\u003C7.0 g\u002FdL.","Baseline and at 9 months after baseline",{"measure":19,"description":20,"timeFrame":21},"Hemoglobin concentration (continuous, g\u002FdL)","Hemoglobin concentration (continuous, g\u002FdL) at baseline and 4 and 9 months after baseline.","At baseline and 4 and 9 months after baseline.",{"measure":23,"description":24,"timeFrame":25},"Adherence to MMS","* Self-reported daily consumption of MMS.\n* On-time pick-up of MMS refills from designated facilities.\n* Where feasible, facility or provider logs will be used to verify refill adherence.","At baseline, at 4 and 9 months after baseline",{"measure":27,"description":28,"timeFrame":29},"Nutrition literacy","The Adolescent Nutrition Literacy Scale is a 22 item, Likert type (1-5) instrument with good internal consistency (Cronbach's α=0.80), yielding total scores from 22 to 110 where higher scores indicate greater nutrition literacy across three dimensions: functional nutritional literacy (7 items), interactive nutritional literacy (6 items), and critical nutritional literacy (9 items).","At baseline and 4 and 9 months after baseline",{"measure":31,"description":32,"timeFrame":29},"Dietary behaviors","Fruit and vegetable intake will be calculated as the sum of affirmative (1 = Yes) responses to consumption of dark green leafy vegetables, vitamin A-rich vegetables, roots and tubers, vitamin A-rich fruits, other vegetables, and other fruits within the past 24 hours.\n\n18 item 24 hour Dietary Diversity Score (DDS) based on FAO MDD W food groups, adapted for adolescents to also capture energy dense, nutrient poor foods: Dietary diversity indices will be based on the total 18 food group scores and yes\u002Fno item responses, summed to give a total score from 0 to 18, where higher scores indicate more diverse and potentially more nutritionally adequate diets.",{"measure":34,"description":35,"timeFrame":29},"Physical activity","Self-reported frequency and duration of moderate-to-vigorous physical activity, using validated or adapted tools appropriate for adolescents.",{"measure":37,"description":38,"timeFrame":29},"Anthropometric outcomes","Height will be measured to the nearest 0.1 cm using a stadiometer and weight will be measured to the nearest 100 g using an electronic scale. Body Mass Index (BMI) will be calculated as weight in kilograms divided by height in meters squared and rounded to one decimal place. BMI-for-age z-scores will be calculated using the WHO standard for children aged 15-19 years.",{"measure":40,"description":41,"timeFrame":29},"Digital literacy","* Skills and confidence in using digital devices, applications, and online information sources.\n* Assessed using a brief tool integrated into adolescent surveys.",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":42,"timePerspective":42,"maskingInfo":48},"RANDOMIZED","PARALLEL","This is a three-arm, individually randomized, parallel-group trial. Adolescents are randomly assigned in a 1:1:1 ratio to: (1) control (in-person nutrition education + MMS only); (2) intervention arm I (control package + weekly one-way SMS); or (3) intervention arm II (intervention arm I package + fortnightly in-person digital group nutrition sessions with peer content creation). All arms are followed for 9 months with repeated outcome assessments at 4 and 9 months.","PREVENTION",{"masking":49,"maskingDescription":42,"whoMasked":50},"SINGLE",[51],"OUTCOMES_ASSESSOR","Adolescence (10-19 years) is a critical period of rapid growth and development, second only to the first 1,000 days of life. In low- and middle-income countries, including Tanzania, adolescents experience a double burden of malnutrition, with anemia and other micronutrient deficiencies co-existing alongside rising rates of overweight and obesity. Iron deficiency and poor dietary diversity are major drivers of anemia and are associated with impaired cognitive function, reduced physical capacity, poorer school performance, and compromised future reproductive health. Adolescent girls are at particularly high risk because of increased iron requirements related to growth and menstruation, often in the context of poverty, food insecurity, and constrained access to health services.\n\nAt the same time, access to mobile phones and digital technologies is expanding in sub-Saharan Africa, though important inequities remain by geography, gender, and socioeconomic status. Digital health and nutrition strategies (e.g., SMS reminders, mobile messaging, social media content) have shown promise in improving knowledge, some health behaviors, and adherence to supplementation. However, most evidence comes from high-income settings, and few interventions have been designed for or rigorously evaluated among adolescents in low-resource African contexts. Existing programs often emphasize information provision rather than sustained behavior change and rarely address structural barriers to digital access or gender-related inequities. There is limited evidence on how to design and implement digital strategies that effectively complement micronutrient supplementation for adolescents in sub-Saharan Africa.\n\nThis trial builds on work by the Africa Research, Implementation Science and Education (ARISE) Network and the ARISE-NUTRINT initiative, which have documented high levels of adolescent anemia and malnutrition in sub-Saharan Africa and explored how adolescents engage with digital technologies for health. Prior mixed-methods research in Tanzania has shown that adolescents are interested in digital nutrition content but face barriers such as limited or shared device access, school policies restricting phone use, and the cost and quality of internet connectivity. The present study is designed to test whether \"digitally layered\" nutrition education strategies, added to a standard package of multiple micronutrient supplementation (MMS), can reduce anemia and improve nutrition-related behaviors among adolescents.\n\nThe ClinicalTrials.gov registration pertains to the main randomized controlled trial. The intervention package was informed by preceding co-design and prototyping phases involving adolescents and key stakeholders (parents, teachers, school administrators, government representatives, civil society, software engineers, and content developers). Using a human-centered design approach, these preparatory phases identified adolescents' needs, preferences, and barriers related to nutrition, anemia, and digital access, and were used to develop and refine prototypes of SMS\u002FWhatsApp messages, in-person digital sessions, and youth-created digital content. Only the finalized intervention components emerging from these phases are evaluated in the main trial.\n\nThe main study is a three-arm, individually randomized, non-blinded controlled trial conducted within the Dar es Salaam Health and Demographic Surveillance System (HDSS) area in Tanzania. A total of 1,200 adolescents (approximately equal numbers of boys and girls) aged 15-19 years with access to at least one mobile phone (own or shared) will be enrolled. Participants are randomized in a 1:1:1 ratio, stratified by gender, to: (1) Control; (2) Intervention Arm I (digital Strategy I); or (3) Intervention Arm II (digital Strategy I plus digital Strategy II). Each participant is followed for approximately 9 months, with data collection at baseline, midline (4 months), and endline (9 months).\n\nAll three arms receive a core package consisting of in-person nutrition education and MMS. The in-person session is a brief, structured, face-to-face encounter at baseline delivered by trained study staff. It covers adolescent growth and nutrition, causes and consequences of anemia, the role of MMS in preventing micronutrient deficiencies, practical guidance on iron-rich foods and balanced diets, and information on where and how to obtain MMS refills and report side effects. Participants also receive printed brochures tailored to adolescents, addressing healthy diets and dietary diversity, iron-rich foods and enhancers\u002Finhibitors of iron absorption, recognition and prevention of anemia, correct use of MMS, and appropriate health service use. At baseline, all participants receive a 2-month supply of MMS tablets and are instructed to obtain refills approximately every 2 months at designated health facilities. Local health personnel and\u002For peer support workers assist with MMS distribution and refills.\n\nDigital Strategy I (Intervention Arm I and Intervention Arm II) consists of low-intensity, one-way mobile messaging (SMS and\u002For WhatsApp). Once per week, participants receive short, age-appropriate messages to the phone number(s) provided at enrollment (own or shared household device). Messages reinforce key nutrition and anemia content from the core session and brochures, prompt daily MMS use and on-time refills, and encourage healthy dietary and physical activity behaviors. Content is designed for low-bandwidth settings and is adapted to be relevant for boys and girls, including material specific to menstruation and iron needs for girls, while maintaining a consistent set of core messages across participants.\n\nDigital Strategy II (Intervention Arm II only) is a higher-intensity engagement package delivered in addition to the core package and Strategy I. It includes regular in-person digital nutrition education sessions (approximately every two weeks) held in school computer labs or community venues and facilitated by trained teacher assistants or peer support workers. These sessions use a simple digital platform (e.g., app or offline interface) incorporating short audio-visual lessons, animations, infographics, interactive quizzes and games, and guided problem-solving activities. Adolescents also work individually or in small groups to create digital content (e.g., short videos, infographics, posters, and brief peer-tailored messages about nutrition and anemia). Youth-created materials can be shared within peer networks via direct phone transfer (e.g., Bluetooth, SD cards) and, where feasible and acceptable, via local social media or messaging platforms. This component is intended to promote active engagement, peer-to-peer diffusion of accurate information, and greater ownership and motivation. Some unintentional exposure to such content among adolescents in the control or Intervention Arm I groups may occur through natural social networks; this is documented through follow-up assessments of exposure to digital nutrition content.\n\nThe primary outcome is anemia prevalence at 9 months, defined using WHO age- and sex-specific hemoglobin thresholds, with hemoglobin assessed via finger-prick capillary samples at baseline, 4 months, and 9 months. Key secondary outcomes include severity of anemia, hemoglobin concentrations, adherence to MMS (consumption and refills), nutrition literacy, dietary behaviors (including fruit and vegetable intake and dietary diversity), physical activity, anthropometric indicators (including BMI categories), and indicators of digital literacy, access, and engagement. Process outcomes (e.g., reach and fidelity of digital delivery, message delivery and recall, attendance at digital sessions, and exposure to youth-created materials) and economic outcomes (costs and cost-effectiveness of the digital layering strategies) will also be assessed. Outcomes will be examined overall and stratified by gender to assess potential differential effects among boys and girls.\n\nQuantitative analyses will follow an intention-to-treat principle, including all randomized participants in their assigned arms regardless of intervention exposure level. The primary comparison will estimate the effect of Intervention Arms I and II versus the Control arm on anemia prevalence at 9 months, with models accounting for repeated measures and pre-specified covariates. Secondary analyses will examine impacts on other hematologic, behavioral, anthropometric, and digital outcomes and will formally assess effect modification by gender. Complementary qualitative data from focus group discussions with adolescents and interviews with intervention delivery personnel and stakeholders will be analyzed thematically to explore acceptability, feasibility, fidelity, perceived benefits and harms, and contextual factors influencing implementation. Cost and cost-effectiveness analyses will use trial data combined with additional epidemiologic and costing information to estimate the incremental cost per anemia case averted and to inform scalability.\n\nThe trial is considered minimal risk. Potential risks relate primarily to minor discomfort from finger-prick blood collection, possible mild side effects from MMS, and privacy or confidentiality concerns related to data collection and group discussions. Standard procedures for informed consent\u002Fassent, secure data handling, and referral to health services are in place. A data and safety monitoring plan governs the reporting and review of adverse events and any unanticipated problems. Overall, the study is designed to generate rigorous evidence on whether layering appropriately designed digital interventions onto MMS supplementation is a feasible, acceptable, and cost-effective strategy to reduce anemia and improve broader nutrition and health behaviors among adolescents in Tanzania, with implications for similar low- and middle-income settings.",[54,61,66],{"label":55,"type":56,"description":57,"interventionNames":58},"Arm I: Control","ACTIVE_COMPARATOR","Participants in the control arm receive the core package without additional digital interventions. This includes:\n\n* A brief, in-person information session on adolescent nutrition, anemia, and the use and importance of multiple micronutrient supplements (MMS).\n* A set of printed nutrition education brochures covering adolescent nutrition, anemia prevention, MMS use, and where to seek care.\n* A 2-month supply of MMS tablets in bottles, with instructions for daily consumption and written guidance on when and where to obtain refills, as well as contact information for reporting any side effects.\n\nControl arm participants do not receive weekly SMS messages or the fortnightly in-person digital group nutrition sessions.",[59,60],"Behavioral: Behavioral: SMS Intervention (Intervention Arm I)","Behavioral: Behavioral: In Person Digital Arm (Intervention Arm II)",{"label":62,"type":63,"description":64,"interventionNames":65},"Behavioral: SMS Intervention (Intervention Arm I)","EXPERIMENTAL","Participants in the SMS arm receive the same core package as the control group plus a low intensity digital intervention: Core package (as in Control): One time in person information session on adolescent nutrition, anemia, and correct use of multiple micronutrient supplements (MMS). Printed nutrition education brochures. A 2 month supply of daily MMS tablets, with instructions and access to bimonthly refills. Digital component (Strategy I): Weekly one way SMS messages sent to a phone number provided at enrollment (adolescent's own or a household\u002Fshared phone). Messages reinforce key nutrition and anemia information, remind adolescents to take MMS daily, and prompt them to obtain MMS refills on time. Content is age appropriate and gender sensitive but maintains consistent core messages for all participants. No fortnightly in person digital group sessions are provided in this arm.",[59],{"label":67,"type":63,"description":68,"interventionNames":69},"Behavioral: In Person Digital Arm (Intervention Arm II)","Participants in the in person digital arm receive the full intervention package: Core package (as in Control): - One time in person information session on adolescent nutrition, anemia, and correct use of MMS. - Printed nutrition education brochures. - A 2 month supply of daily MMS tablets, with instructions and access to bimonthly refills. Digital Strategy I (as in SMS Arm): - Weekly one way SMS messages reinforcing nutrition and anemia messages and reminding adolescents to take MMS and obtain refills. Digital Strategy II (additional in person digital component): - Fortnightly, 1 hour in person digital group nutrition education sessions held in school computer labs or similar settings, facilitated by trained teacher assistants or peer support workers. - Sessions use audio visual and interactive digital content (e.g., animations, quizzes, games) to teach nutrition and anemia related topics. - Adolescents co-create and share digital nutrition content",[60],[71,75],{"type":72,"name":62,"description":73,"armGroupLabels":74,"otherNames":42},"BEHAVIORAL","Participants in the SMS arm receive the same core package as the control group plus a low intensity digital intervention: Core package (as in Control): One time in person information session on adolescent nutrition, anemia, and correct use of multiple micronutrient supplements (MMS). Printed nutrition education brochures. A 2 month supply of daily MMS tablets, with instructions and access to bimonthly refills. Digital component (Strategy I): Weekly one way SMS\u002FWhatsApp messages sent to a phone number provided at enrollment (adolescent's own or a household\u002Fshared phone). Messages reinforce key nutrition and anemia information, remind adolescents to take MMS daily, and prompt them to obtain MMS refills on time. Content is age appropriate and gender sensitive but maintains consistent core messages for all participants. No fortnightly in person digital group sessions are provided in this arm.",[55,62],{"type":72,"name":67,"description":76,"armGroupLabels":77,"otherNames":42},"Participants in the in person digital arm receive the full intervention package: Core package (as in Control): - One time in person information session on adolescent nutrition, anemia, and correct use of MMS. - Printed nutrition education brochures. - A 2 month supply of daily MMS tablets, with instructions and access to bimonthly refills. Digital Strategy I (as in SMS Arm): - Weekly one way SMS messages reinforcing nutrition and anemia messages and reminding adolescents to take MMS and obtain refills. Digital Strategy II (additional in person digital component): - Fortnightly, 1 hour in person digital group nutrition education sessions held in school computer labs or similar settings, facilitated by trained teacher assistants or peer support workers. - Sessions use audio visual and interactive digital content (e.g., animations, quizzes, games) to teach nutrition and anemia related topics. - Adolescents co-create and disseminate digital nutrition content",[55,67],[79,84],{"name":80,"role":81,"phone":82,"phoneExt":42,"email":83},"Wafaie Fawzi, MD, DrPH, MPH","CONTACT","+16178181864","mina@hsph.harvard.edu",{"name":85,"role":81,"phone":86,"phoneExt":42,"email":87},"Sachin Shinde, PhD, MPA, MA","+16174351445","sshinde@hsph.harvard.edu",[89],{"facility":90,"status":42,"city":91,"state":42,"zip":42,"country":92,"countryCode":42,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Dar Health and Demographic Surveillance System Area","Dar es Salaam","Tanzania",{"type":94,"coordinates":95},"Point",[96,97],39.26951,-6.82349,{"lat":97,"lon":96},[100,104],{"name":101,"role":81,"phone":102,"phoneExt":42,"email":103},"Mary Mawanyika-Sando, MD, MPH","+255713269063","msando@aaph.or.tz",{"name":105,"role":81,"phone":106,"phoneExt":42,"email":107},"Alison Kabanda, PhD","+255620407037","akabanda@aaph.or.tz",{"type":109,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Wafaie Fawzi","Professor",[113],{"name":114,"class":6},"Africa Academy for Public Health","100630907",false,"NCT07493772","Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania","MMSDigitalTZ","Inclusion Criteria:\n\n* Aged 15-19 years at enrollment.\n* Resident in the Dar es Salaam HDSS coverage area.\n* Has access to at least one phone (own or shared within the household; feature phone or smartphone).\n* Demonstrates basic literacy skills sufficient to understand simple written messages.\n* Has capacity to provide informed consent (for those ≥18 years) or assent (for those \\\u003C18 years, with parental\u002Fguardian consent).\n\nExclusion Criteria:\n\n* Currently pregnant.\n* Enrolled in the ARISE-NUTRINT trial.\n* Currently taking iron and folic acid or multiple micronutrient tablets for anemia outside this study.\n* Known to have HIV infection at the time of screening.\n* More than one eligible adolescent per household: if multiple adolescents meet criteria in a household, one will be randomly selected to participate.",true,"ALL","15 Years","19 Years",{"count":126,"type":127},1200,"ESTIMATED","INTERVENTIONAL",[130],"NA","This study is a three-arm, individually randomized controlled trial evaluating the impact of digitally delivered nutrition education, layered onto multiple micronutrient supplementation (MMS), on anemia and related health behaviors among adolescents in Dar es Salaam, Tanzania. A total of 1,200 adolescents aged 15-19 years with access to a phone (own or shared) will be enrolled from the Dar es Salaam Health and Demographic Surveillance System and followed for 9 months, with assessments at baseline, 4 months, and 9 months.\n\nAll participants will receive a brief in-person nutrition education session, printed brochures on adolescent nutrition and anemia, and a 2-month supply of daily MMS tablets with instructions and access to refills (Control arm). In Intervention Arm I, participants will receive the same package plus weekly one-way SMS\u002FWhatsApp messages reinforcing key nutrition content and adherence to MMS and refills. In Intervention Arm II, participants will receive all components of Arm I plus fortnightly, in-person group digital nutrition education sessions that include interactive content and opportunities to co-create and share digital nutrition messages with peers. All participants will receive information on replenishing the tablets. Participants in Intervention Arm I and Intervention Arm II will receive additional nutrition, diet, and physical activity-related messages along with reminders and motivational encouragement to replenish their supplement stocks.\n\nThe primary outcome is anemia prevalence, assessed using hemoglobin concentration and WHO age- and sex-specific cutoffs. Secondary outcomes include moderate\u002Fsevere anemia, hemoglobin levels, adherence to MMS pick-up and consumption, nutrition literacy, dietary diversity, fruit and vegetable intake, physical activity, underweight\u002Foverweight\u002Fobesity, and digital literacy. The trial also includes a mixed-methods process evaluation of feasibility, acceptability, reach, engagement with the digital components, and a cost estimation of the digital strategies.",[133],"Anemia",[135],"Adolescents, multiple micronutrient supplements, RCT, Tanzania","NOT_YET_RECRUITING","2026-03-20",{"date":139,"type":140},"2026-03-25","ACTUAL",{"date":142,"type":127},"2026-05-01",{"date":144,"type":127},"2027-03-31",{"name":5,"class":6},1]