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临床试验/NCT07493772
NCT07493772尚未招募不适用

Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania

Harvard School of Public Health (HSPH)1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,200
试验地点
1
主要终点
Anemia prevalence

研究概览

简要总结

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.

All 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/WhatsApp 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.

The primary outcome is anemia prevalence, assessed using hemoglobin concentration and WHO age- and sex-specific cutoffs. Secondary outcomes include moderate/severe anemia, hemoglobin levels, adherence to MMS pick-up and consumption, nutrition literacy, dietary diversity, fruit and vegetable intake, physical activity, underweight/overweight/obesity, 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.

详细描述

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.

At 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.

This 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.

The 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/WhatsApp 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.

The 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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 15-19 years at enrollment.
  • Resident in the Dar es Salaam HDSS coverage area.
  • Has access to at least one phone (own or shared within the household; feature phone or smartphone).
  • Demonstrates basic literacy skills sufficient to understand simple written messages.
  • Has capacity to provide informed consent (for those ≥18 years) or assent (for those <18 years, with parental/guardian consent).

排除标准

  • Currently pregnant.
  • Enrolled in the ARISE-NUTRINT trial.
  • Currently taking iron and folic acid or multiple micronutrient tablets for anemia outside this study.
  • Known to have HIV infection at the time of screening.
  • More than one eligible adolescent per household: if multiple adolescents meet criteria in a household, one will be randomly selected to participate.

研究组 & 干预措施

Arm I: Control

Active Comparator

Participants in the control arm receive the core package without additional digital interventions. This includes:

  • A brief, in-person information session on adolescent nutrition, anemia, and the use and importance of multiple micronutrient supplements (MMS).
  • A set of printed nutrition education brochures covering adolescent nutrition, anemia prevention, MMS use, and where to seek care.
  • 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.

Control arm participants do not receive weekly SMS messages or the fortnightly in-person digital group nutrition sessions.

干预措施: Behavioral: SMS Intervention (Intervention Arm I) (Behavioral)

Arm I: Control

Active Comparator

Participants in the control arm receive the core package without additional digital interventions. This includes:

  • A brief, in-person information session on adolescent nutrition, anemia, and the use and importance of multiple micronutrient supplements (MMS).
  • A set of printed nutrition education brochures covering adolescent nutrition, anemia prevention, MMS use, and where to seek care.
  • 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.

Control arm participants do not receive weekly SMS messages or the fortnightly in-person digital group nutrition sessions.

干预措施: Behavioral: In Person Digital Arm (Intervention Arm II) (Behavioral)

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/shared 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.

干预措施: Behavioral: SMS Intervention (Intervention Arm I) (Behavioral)

Behavioral: In Person Digital Arm (Intervention Arm II)

Experimental

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

干预措施: Behavioral: In Person Digital Arm (Intervention Arm II) (Behavioral)

结局指标

主要结局

Anemia prevalence

时间窗: Baseline, at 4 months and 9 months after baseline

Anemia prevalence at 9 months post-baseline, defined using WHO age- and sex-specific hemoglobin cutoffs: * Boys aged ≥15 years: hemoglobin \<13.0 g/dL. * Girls aged ≥15 years: hemoglobin \<12.0 g/dL. * 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).

次要结局

  • Moderate and severe anemia(Baseline and at 9 months after baseline)
  • Hemoglobin concentration (continuous, g/dL)(At baseline and 4 and 9 months after baseline.)
  • Adherence to MMS(At baseline, at 4 and 9 months after baseline)
  • Nutrition literacy(At baseline and 4 and 9 months after baseline)
  • Dietary behaviors(At baseline and 4 and 9 months after baseline)
  • Physical activity(At baseline and 4 and 9 months after baseline)
  • Anthropometric outcomes(At baseline and 4 and 9 months after baseline)
  • Digital literacy(At baseline and 4 and 9 months after baseline)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wafaie Fawzi

Professor

Harvard School of Public Health (HSPH)

研究点 (1)

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