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El ensayo clínico NCT07493772 (MMSDigitalTZ) para Anemia está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania (MMSDigitalTZ) 1200 Aleatorizado Adolescentes Dietético
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07493772 (MMSDigitalTZ) es un estudio intervencionista para Anemia. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de mayo de 2026 hasta completar 1200 participantes. Dirigido por Harvard School of Public Health (HSPH), se espera que finalice el 31 de marzo de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
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...Mostrar más
Descripción detallada
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 ...Mostrar más
Título oficial
Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania
Condiciones médicas
AnemiaOtros ID del estudio
- MMSDigitalTZ
- IRB25-0704
- IRB25-0704 (Otro identificador) (Harvard T H Chan School of Public Health IRB)
Número del NCT
Inicio del estudio (real)
2026-05-01
Última actualización
2026-03-25
Fecha de finalización (estimada)
2027-03-31
Inscripción (prevista)
1200
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
Adolescents, multiple micronutrient supplements, RCT, Tanzania
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Comparador activoArm 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...Mostrar más | 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...Mostrar más 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 ...Mostrar más |
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...Mostrar más | 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...Mostrar más |
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 ...Mostrar más | 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 ...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño, Adulto
Edad mínima
15 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- 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.
Parte responsable del estudio
Wafaie Fawzi, Investigador principal, Professor, Harvard School of Public Health (HSPH)
Contactos centrales del estudio
Contacto: Wafaie Fawzi, MD, DrPH, MPH, +16178181864, [email protected]
Contacto: Sachin Shinde, PhD, MPA, MA, +16174351445, [email protected]
1 Centros del estudio en 1 países
Dar Health and Demographic Surveillance System Area, Dar es Salaam, Tanzania
Mary Mawanyika-Sando, MD, MPH, Contacto, +255713269063, [email protected]
Alison Kabanda, PhD, Contacto, +255620407037, [email protected]