Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania

NCT07493772 | Not Yet Recruiting DMC

• 1 other identifier: IRB25-0704
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Keywords

Adolescents, multiple micronutrient supplements, RCT, Tanzania

Outcome Measures

Primary Outcomes (1)

• Anemia prevalence

  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).

  Baseline, at 4 months and 9 months after baseline

Secondary Outcomes (8)

• 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

Study Arms (3)

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.

Behavioral: Behavioral: SMS Intervention (Intervention Arm I); Behavioral: Behavioral: In Person Digital Arm (Intervention Arm II)

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.

Behavioral: Behavioral: SMS Intervention (Intervention Arm I)

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

Behavioral: Behavioral: In Person Digital Arm (Intervention Arm II)

Interventions

Behavioral: SMS Intervention (Intervention Arm I) 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/WhatsApp 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.

Arm I: Control; Behavioral: SMS Intervention (Intervention Arm I)

Behavioral: In Person Digital Arm (Intervention Arm II) BEHAVIORAL

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

Arm I: Control; Behavioral: In Person Digital Arm (Intervention Arm II)

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Africa Academy for Public Health: collaborator

Study Sites (1)

Dar Health and Demographic Surveillance System Area

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Wafaie Fawzi, MD, DrPH, MPH

CONTACT

+16178181864; mina@hsph.harvard.edu

Sachin Shinde, PhD, MPA, MA

CONTACT

+16174351445; sshinde@hsph.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 25, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

TA (1)