رادار التجارب AI | ||
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حالة التجربة السريرية NCT07493772 (MMSDigitalTZ) لـ فقر الدم هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania (MMSDigitalTZ) ١٬٢٠٠ عشوائية المراهقون نظام غذائي
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07493772 (MMSDigitalTZ) هي دراسة تدخُّلية لـفقر الدم وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٤ ذو القعدة ١٤٤٧ هـ لتجنيد ١٬٢٠٠ مشاركًا. يقودها Harvard School of Public Health (HSPH)، ومن المتوقع اكتمالها بحلول ٢٣ شوال ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٦ شوال ١٤٤٧ هـ.
الملخص
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...عرض المزيد
وصف مفصل
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 ...عرض المزيد
العنوان الرسمي
Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania
الحالات الطبية
فقر الدممعرّفات دراسة أخرى
- MMSDigitalTZ
- IRB25-0704
- IRB25-0704 (معرف آخر) (Harvard T H Chan School of Public Health IRB)
NCT معرّف
تاريخ البدء (فعلي)
2026-05-01
آخر تحديث مُنشور
2026-03-25
تاريخ الاكتمال (المقدر)
2027-03-31
عدد المشاركين المخطط لهم
١٬٢٠٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
Adolescents, multiple micronutrient supplements, RCT, Tanzania
الغرض الأساسي
وقاية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
مقارن نشطArm 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...عرض المزيد | 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...عرض المزيد 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 ...عرض المزيد |
تجريبيةBehavioral: 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...عرض المزيد | 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...عرض المزيد |
تجريبيةBehavioral: 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 ...عرض المزيد | 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 ...عرض المزيد |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل, بالغ
العمر الأدنى للدراسة
15 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
- 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.
الجهة المسؤولة عن الدراسة
Wafaie Fawzi, المحقق الرئيسي, Professor, Harvard School of Public Health (HSPH)
جهة اتصال مركزية للدراسة
جهة اتصال: Wafaie Fawzi, MD, DrPH, MPH, +16178181864, [email protected]
جهة اتصال: Sachin Shinde, PhD, MPA, MA, +16174351445, [email protected]
1 مواقع الدراسة في 1 بلدان
Dar Health and Demographic Surveillance System Area, Dar es Salaam, Tanzania
Mary Mawanyika-Sando, MD, MPH, جهة اتصال, +255713269063, [email protected]
Alison Kabanda, PhD, جهة اتصال, +255620407037, [email protected]