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Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania (MMSDigitalTZ) 1,200 Randomized Adolescent Dietary
Clinical Trial NCT07493772 (MMSDigitalTZ) is an interventional study for Anemia and is currently not yet recruiting. Enrollment is planned to begin on May 1, 2026 and continue until the study accrues 1,200 participants. Led by Harvard School of Public Health (HSPH), this study is expected to complete by March 31, 2027. The latest data from ClinicalTrials.gov was last updated on March 25, 2026.
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 Demogr...Show More
Detailed Description
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 ...Show More
Official Title
Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania
Conditions
AnemiaOther Study IDs
- MMSDigitalTZ
- IRB25-0704
- IRB25-0704 (Other Identifier) (Harvard T H Chan School of Public Health IRB)
NCT ID Number
Start Date (Actual)
2026-05-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2027-03-31
Enrollment (Estimated)
1,200
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Adolescents, multiple micronutrient supplements, RCT, Tanzania
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorArm I: Control 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 t...Show More | Behavioral: SMS Intervention (Intervention Arm I) 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. Digita...Show More 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 ...Show More |
ExperimentalBehavioral: SMS Intervention (Intervention Arm I) 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. Digita...Show More | Behavioral: SMS Intervention (Intervention Arm I) 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. Digita...Show More |
ExperimentalBehavioral: 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 ...Show More | 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 ...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Moderate and severe anemia | Moderate and severe anemia at 9 months:
Boys aged ≥15 years:
Moderate anemia: 8.0-10.9 g/dL. Severe anemia: \<8.0 g/dL.
Girls aged ≥15 years:
Moderate anemia: 7.0-10.9 g/dL. Severe anemia: \<7.0 g/dL. | Baseline and at 9 months after baseline |
Hemoglobin concentration (continuous, g/dL) | Hemoglobin concentration (continuous, g/dL) at baseline and 4 and 9 months after baseline. | At baseline and 4 and 9 months after baseline. |
Adherence to MMS | * Self-reported daily consumption of MMS.
* On-time pick-up of MMS refills from designated facilities.
* Where feasible, facility or provider logs will be used to verify refill adherence. | At baseline, at 4 and 9 months after baseline |
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 |
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.
18 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/no item responses, summed to give a total score from 0 to 18, where higher scores indicate more diverse and potentially more nutritionally adequate diets. | At baseline and 4 and 9 months after baseline |
Physical activity | Self-reported frequency and duration of moderate-to-vigorous physical activity, using validated or adapted tools appropriate for adolescents. | At baseline and 4 and 9 months after baseline |
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. | At baseline and 4 and 9 months after baseline |
Digital literacy | * Skills and confidence in using digital devices, applications, and online information sources.
* Assessed using a brief tool integrated into adolescent surveys. | At baseline and 4 and 9 months after baseline |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
15 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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).
- 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.
Harvard School of Public Health (HSPH)Africa Academy for Public HealthStudy Responsible Party
Wafaie Fawzi, Principal Investigator, Professor, Harvard School of Public Health (HSPH)
Study Central Contact
Contact: Wafaie Fawzi, MD, DrPH, MPH, +16178181864, [email protected]
Contact: Sachin Shinde, PhD, MPA, MA, +16174351445, [email protected]
1 Study Locations in 1 Countries
Dar Health and Demographic Surveillance System Area, Dar es Salaam, Tanzania
Mary Mawanyika-Sando, MD, MPH, Contact, +255713269063, [email protected]
Alison Kabanda, PhD, Contact, +255620407037, [email protected]