| Changes to trial information |
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| Trial Information |
Public title |
19/03/2025 |
Translation from the French to the English language |
Efficacité d’un programme de renforcement des capacités sur les connaissances, les attitudes et les comportement des infirmiers scolaires vis-à-vis la prévention de l’obésité des adolescents dans la région de Sousse |
"Effectiveness of a capacity-building program on the knowledge, attitudes, and behavior of school nurses regarding adolescent obesity prevention in the Sousse region." |
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| Trial Information |
Official scientific title |
19/03/2025 |
Translation from the French to the English language |
Efficacité d'un programme de renforcement des capacités pour la prévention de l'obésité chez les adolescents sur les compétences perçues, les attitudes professionnelles et les défis rencontrés par les infirmières scolaires dans une communauté à revenu intermédiaire inférieur : Un essai contrôlé randomisé |
Effectiveness of a Capacity-Building Program for adolescent obesity prevention on perceived skills, professional attitudes, and challenges among School Nurses in a lower-middle-income community: A Randomized Controlled Trial |
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Trial description |
19/03/2025 |
Translation from the French to the English language |
La lutte contre l'obésité est un défi majeur dans la réduction des maladies chroniques. Pour relever les défis de la prévention et de l'intervention, une activité éducative a été mise en place pour promouvoir l'échange et l'apprentissage interprofessionnels. Cette étude vise à évaluer l'efficacité d'un programme de renforcement des capacités destiné aux infirmières scolaires pour prévenir l'obésité chez les adolescents dans la région de Sousse. |
Combating obesity is a major challenge in reducing chronic diseases. To address the challenges of prevention and intervention, an educational activity has been implemented to promote interprofessional exchange and learning. This study aims to evaluate the effectiveness of a capacity-building program for school nurses to prevent obesity among adolescents in the Sousse region |
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Trial phase |
19/03/2025 |
Translation from the French to the English language |
|
Phase-4 |
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Date
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Reason
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| Study Design |
Allocation sequence |
28/02/2025 |
No change |
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Simple randomization using by using procedures such as coin-tossing or dice-rolling |
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Date
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| Study Design |
Allocation sequence |
19/03/2025 |
Translation from the French to the English language |
|
Simple randomization using by using procedures such as coin-tossing or dice-rolling |
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Date
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| Study Design |
Allocation concealment |
19/03/2025 |
Translation from the French to the English language |
Numbered containers |
Sealed opaque envelopes |
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Field Name
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Date
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Reason
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| Eligibility |
Inclusion criteria |
19/03/2025 |
Translation from the French to the English language. |
- Les infirmiers scolaires travaillant dans la région de Sousse ;
- Les infirmiers qui ont accepté volontairement de participer à l’intervention. |
- School nurses working in the Sousse region
- Nurses who voluntarily agreed to participate in the intervention |
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Date
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| Eligibility |
Exclusion criteria |
19/03/2025 |
Translation from the French to the English language. |
- Les infirmiers ayant participé au pré-test de traduction du questionnaire ;
- Les infirmiers qui étaient en congé de longue durée ;
- Les infirmiers qui ont refusé de participer à l’étude. |
- Nurses who participated in the pre-test translation of the questionnaire
- Nurses who were on long-term leave
- Nurses who refused to participate in the study |
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| Intervention |
Intervention List |
19/03/2025 |
Translation from the French to the English language |
Experimental Group, formation des infirmiers, compétences des infirmiers, 4 jours, L'intervention, inspirée par un programme de l'Université du Manitoba, visait à améliorer les compétences des infirmières scolaires dans la prévention de l'obésité chez les adolescents. Le programme « Formez les formateurs » s'est déroulé sur quatre jours, avec une séance par semaine. Chaque jour consistait en une session de six heures. Ce programme de formation multidimensionnel est facilité par un psychologue, un nutritionniste, un professeur d'éducation physique et un endocrinologue. Le psychologue a formé les infirmières aux techniques de communication positive visant à encourager les adolescents à adopter des modes de vie sains tout en les aidant à évaluer leur motivation à changer leurs comportements. Le nutritionniste a dispensé une éducation sur les principes de nutrition équilibrée et a partagé des exemples pratiques de plans de repas sains pour guider les adolescents dans leurs choix alimentaires. Le professeur d'éducation physique a souligné l'importance d'une activité physique régulière et a proposé des stratégies pour intégrer l'exercice dans la routine quotidienne des adolescents. Enfin, l'endocrinologue a abordé les causes médicales et les conséquences de l'obésité et a formé les infirmières à reconnaître les signes cliniques nécessitant une référence à un spécialiste. Chaque séance s'est terminée par des discussions interactives pour renforcer l'apprentissage et favoriser l'engagement., 49, |
Experimental Group, formation des infirmiers, Nursing skills, 4 days, The intervention, inspired by a University of Manitoba program, aimed to improve the skills of school nurses in preventing obesity among adolescents. The 'Train the Trainers' program took place over four days, with one session per week. Each day consisted of a six-hour session. This multidimensional training program was facilitated by a psychologist, a nutritionist, a physical education teacher, and an endocrinologist. The psychologist trained the nurses in positive communication techniques to encourage adolescents to adopt healthy lifestyles while helping them assess their motivation to change their behaviors. The nutritionist provided education on balanced nutrition principles and shared practical examples of healthy meal plans to guide adolescents in their food choices. The physical education teacher emphasized the importance of regular physical activity and proposed strategies for incorporating exercise into the daily routine of adolescents. Finally, the endocrinologist addressed the medical causes and consequences of obesity and trained the nurses to recognize clinical signs requiring referral to a specialist. Each session ended with interactive discussions to reinforce learning and promote engagement, 49, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
20/03/2025 |
Translation from the French to the English |
Experimental Group, formation des infirmiers, Nursing skills, 4 days, The intervention, inspired by a University of Manitoba program, aimed to improve the skills of school nurses in preventing obesity among adolescents. The 'Train the Trainers' program took place over four days, with one session per week. Each day consisted of a six-hour session. This multidimensional training program was facilitated by a psychologist, a nutritionist, a physical education teacher, and an endocrinologist. The psychologist trained the nurses in positive communication techniques to encourage adolescents to adopt healthy lifestyles while helping them assess their motivation to change their behaviors. The nutritionist provided education on balanced nutrition principles and shared practical examples of healthy meal plans to guide adolescents in their food choices. The physical education teacher emphasized the importance of regular physical activity and proposed strategies for incorporating exercise into the daily routine of adolescents. Finally, the endocrinologist addressed the medical causes and consequences of obesity and trained the nurses to recognize clinical signs requiring referral to a specialist. Each session ended with interactive discussions to reinforce learning and promote engagement, 49, |
Experimental Group, Nurse Training, Nursing skills, 4 days, The intervention, inspired by a University of Manitoba program, aimed to improve the skills of school nurses in preventing obesity among adolescents. The 'Train the Trainers' program took place over four days, with one session per week. Each day consisted of a six-hour session. This multidimensional training program was facilitated by a psychologist, a nutritionist, a physical education teacher, and an endocrinologist. The psychologist trained the nurses in positive communication techniques to encourage adolescents to adopt healthy lifestyles while helping them assess their motivation to change their behaviors. The nutritionist provided education on balanced nutrition principles and shared practical examples of healthy meal plans to guide adolescents in their food choices. The physical education teacher emphasized the importance of regular physical activity and proposed strategies for incorporating exercise into the daily routine of adolescents. Finally, the endocrinologist addressed the medical causes and consequences of obesity and trained the nurses to recognize clinical signs requiring referral to a specialist. Each session ended with interactive discussions to reinforce learning and promote engagement, 49, |
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Section Name
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Field Name
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Date
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Reason
|
Old Value
|
Updated Value
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| Intervention |
Intervention List |
20/03/2025 |
Translation from French to English |
Control Group, Formation des infirmiers, compétences , 4 jours, L'intervention s'est déroulé sur quatre jours, avec une séance par semaine. Chaque jour consistait en une session de six heures. Ce programme de formation multidimensionnel est facilité par un psychologue, un nutritionniste, un professeur d'éducation physique et un endocrinologue. Le psychologue a formé les infirmières aux techniques de communication positive visant à encourager les adolescents à adopter des modes de vie sains tout en les aidant à évaluer leur motivation à changer leurs comportements. Le nutritionniste a dispensé une éducation sur les principes de nutrition équilibrée et a partagé des exemples pratiques de plans de repas sains pour guider les adolescents dans leurs choix alimentaires. Le professeur d'éducation physique a souligné l'importance d'une activité physique régulière et a proposé des stratégies pour intégrer l'exercice dans la routine quotidienne des adolescents. Enfin, l'endocrinologue a abordé les causes médicales et les conséquences de l'obésité et a formé les infirmières à reconnaître les signes cliniques nécessitant une référence à un spécialiste. Chaque séance s'est terminée par des discussions interactives pour renforcer l'apprentissage et favoriser l'engagement., 46, Dose Comparison |
Control Group, Nurse Training, skills, 4 Days, The intervention took place over four days, with one session per week. Each day consisted of a six-hour session. This multidimensional training program was facilitated by a psychologist, a nutritionist, a physical education teacher, and an endocrinologist. The psychologist trained the nurses in positive communication techniques aimed at encouraging adolescents to adopt healthy lifestyles while helping them assess their motivation to change their behaviors. The nutritionist provided education on the principles of balanced nutrition and shared practical examples of healthy meal plans to guide adolescents in their food choices. The physical education teacher emphasized the importance of regular physical activity and proposed strategies for incorporating exercise into the daily routine of adolescents. Finally, the endocrinologist addressed the medical causes and consequences of obesity and trained the nurses to recognize clinical signs requiring referral to a specialist. Each session ended with interactive discussions to reinforce learning and promote engagement., 46, Dose Comparison |
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Section Name
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Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Intervention |
Intervention List |
20/03/2025 |
Translation from French to English |
Control Group, Nurse Training, skills, 4 Days, The intervention took place over four days, with one session per week. Each day consisted of a six-hour session. This multidimensional training program was facilitated by a psychologist, a nutritionist, a physical education teacher, and an endocrinologist. The psychologist trained the nurses in positive communication techniques aimed at encouraging adolescents to adopt healthy lifestyles while helping them assess their motivation to change their behaviors. The nutritionist provided education on the principles of balanced nutrition and shared practical examples of healthy meal plans to guide adolescents in their food choices. The physical education teacher emphasized the importance of regular physical activity and proposed strategies for incorporating exercise into the daily routine of adolescents. Finally, the endocrinologist addressed the medical causes and consequences of obesity and trained the nurses to recognize clinical signs requiring referral to a specialist. Each session ended with interactive discussions to reinforce learning and promote engagement., 46, Dose Comparison |
Control Group, Nurse Training, Nursing skills, 4 Days, The intervention took place over four days, with one session per week. Each day consisted of a six-hour session. This multidimensional training program was facilitated by a psychologist, a nutritionist, a physical education teacher, and an endocrinologist. The psychologist trained the nurses in positive communication techniques aimed at encouraging adolescents to adopt healthy lifestyles while helping them assess their motivation to change their behaviors. The nutritionist provided education on the principles of balanced nutrition and shared practical examples of healthy meal plans to guide adolescents in their food choices. The physical education teacher emphasized the importance of regular physical activity and proposed strategies for incorporating exercise into the daily routine of adolescents. Finally, the endocrinologist addressed the medical causes and consequences of obesity and trained the nurses to recognize clinical signs requiring referral to a specialist. Each session ended with interactive discussions to reinforce learning and promote engagement., 46, Dose Comparison |
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Section Name
|
Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
| Outcome |
OutCome List |
19/03/2025 |
Translation from the French to the English language |
Primary Outcome, Informations démographiques sur les participants, incluant le sexe, l'âge, l'expérience professionnelle et la profession
Evaluations liées à la gestion de l'obésité incluant une auto-évaluation des compétences perçues, des attitudes professionnelles et des défis perçus, Janvier 2024 |
Primary Outcome, - Demographic information about the participants, including gender, age, professional experience, and profession;
- Assessments related to obesity management, including self-assessment of perceived skills, professional attitudes, and perceived challenges., Janvier 2024 |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Outcome |
OutCome List |
01/04/2025 |
Accuracy and clarification of the outcome time points. |
Primary Outcome, - Demographic information about the participants, including gender, age, professional experience, and profession;
- Assessments related to obesity management, including self-assessment of perceived skills, professional attitudes, and perceived challenges., Janvier 2024 |
Primary Outcome, - Demographic information about the participants, including gender, age, professional experience, and profession;
- Assessments related to obesity management, including self-assessment of perceived skills, professional attitudes, and perceived challenges., Before the intervention: Janvier 2024 |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Outcome |
OutCome List |
19/03/2025 |
Translation from the French to the English language |
Secondary Outcome, Informations démographiques sur les participants, incluant le sexe, l'âge, l'expérience professionnelle et la profession
Evaluations liées à la gestion de l'obésité incluant une auto-évaluation des compétences perçues, des attitudes professionnelles et des défis perçus, Fevrier et juillet 2024 |
Secondary Outcome, - Demographic information about the participants, including gender, age, professional experience, and profession
- Assessments related to obesity management, including self-assessment of perceived skills, professional attitudes, and perceived challenges, Fevrier et juillet 2024 |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Outcome |
OutCome List |
01/04/2025 |
Accuracy and clarification of the outcome time points |
Secondary Outcome, - Demographic information about the participants, including gender, age, professional experience, and profession
- Assessments related to obesity management, including self-assessment of perceived skills, professional attitudes, and perceived challenges, Fevrier et juillet 2024 |
Secondary Outcome, - Demographic information about the participants, including gender, age, professional experience, and profession
- Assessments related to obesity management, including self-assessment of perceived skills, professional attitudes, and perceived challenges, Immediately and six months post-intervention: Fevrier et juillet 2024 |
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Section Name
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Field Name
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Date
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Reason
|
Old Value
|
Updated Value
|
| Recruitment Centre |
RecruitmentCentre List |
20/03/2025 |
Translation from the French to the English language |
School Medical Center, Yahia Ibn Omar Avenue, Sousse, 4000 , Tunisia |
School Medical Center sousse, Yahia Ibn Omar Avenue, Sousse, 4000 , Tunisia |
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Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
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| Recruitment Centre |
RecruitmentCentre List |
19/03/2025 |
Translation from the French to the English language |
Medecine scolaire, .Avenue Yahia Ibn Omar , Sousse, 4000 , Tunisia |
School Medical Center, Yahia Ibn Omar Avenue, Sousse, 4000 , Tunisia |
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Section Name
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Field Name
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Date
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Reason
|
Old Value
|
Updated Value
|
| Ethics |
Ethics List |
19/03/2025 |
Translation from the French to the English language |
TRUE, CEFMS, Rue Mohamed Karoui , Sousse, 4002, Tunisia, , 03 Feb 2024, +21696576310, comite.ethique@famso.u-sousse.tn, 33443_30589_4737.pdf |
TRUE, CEFMS, Mohamed Karoui Street, Sousse, 4002, Tunisia, , 03 Feb 2024, +21696576310, comite.ethique@famso.u-sousse.tn, 33443_30589_4737.pdf |
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Section Name
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Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
| Funding Source |
FundingSources List |
19/03/2025 |
Translation from the French to the English language |
Chaieb Radhia, 4023, Sousse, 4023, Tunisia, Self Funded, |
Radhia Chaieb , 4023, Sousse, 4023, Tunisia, Self Funded, |
|
Section Name
|
Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
| Sponsors |
Sponsors List |
19/03/2025 |
Translation from the French to the English language |
Ghada Saad, Rue Mohamed Karoui , Sousse, 4002, Tunisia, Primary Sponsor, Individual, |
Ghada Saad, Mohamed Karoui Street, Sousse, 4002, Tunisia, Primary Sponsor, Individual, |
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Section Name
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Field Name
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Date
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Reason
|
Old Value
|
Updated Value
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| Contact People |
Contacs List |
19/03/2025 |
Translation from the French to the English language |
Public Enquiries, Souad, Chelbi, Prof., souad_chelbi@yahoo.fr, , +2720002211, Mohamed Karoui Street , Sousse, 4002, Tunisia, Thesis supervisor |
Public Enquiries, Souad, Chalbi, Prof., souad_chelbi@yahoo.fr, souad_chelbi@yahoo.fr, +2720002211, Mohamed Karoui Street , Sousse, 4002, Tunisia, Thesis supervisor |
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Section Name
|
Field Name
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Date
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Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
20/03/2025 |
Translation from the French to the English |
Scientific Enquiries, Ghada, Saad, Dr., ghada.saad6587@gmail.com, ghada.saad6587@gmail.com, +2758130600, Mohamed Karoui Street., Sousse, 4002, Tunisia, supervisor of the thesis |
Scientific Enquiries, Ghada, Saad, Dr., ghada.saad6587@gmail.com, ghada.saad6587@gmail.com, +2758130600, Mohamed Karoui Street, Sousse, 4002., Tunisia, supervisor of the thesis. |
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Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
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| Contact People |
Contacs List |
19/03/2025 |
Translation from the French to the English language |
Principal Investigator, Radhia, Chaieb, Mrs., radhiasousse@gmail.com, , +2795305111, 426 Rue Tanzanie cite riadh, Sousse, 4023, Tunisia, Doctorante |
Principal Investigator, Radhia, Chaieb, Mrs., radhiasousse@gmail.com, radhiasousse@gmail.com, +2795305111, 426 Tanzania Street, Riadh City, Sousse, 4023, Tunisia, Ph.D. student |
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Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
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| Contact People |
Contacs List |
20/03/2025 |
Translation from the French to the English |
Principal Investigator, Radhia, Chaieb, Mrs., radhiasousse@gmail.com, radhiasousse@gmail.com, +2795305111, 426 Tanzania Street, Riadh City, Sousse, 4023, Tunisia, Ph.D. student |
Principal Investigator, Radhia, Chaieb, Mrs., radhiasousse@gmail.com, , +2795305111, 426 Tanzania Street, Riadh City, Sousse., 4023, Tunisia, Ph.D. student |
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Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
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| Contact People |
Contacs List |
19/03/2025 |
Translation from the French to the English language |
Public Enquiries, Souad, Chelbi, Prof., souad_chelbi@yahoo.fr, , +2720002211, Rue Mohamed Karoui , Sousse, 4002, Tunisia, Directeur de these |
Public Enquiries, Souad, Chelbi, Prof., souad_chelbi@yahoo.fr, , +2720002211, Mohamed Karoui Street , Sousse, 4002, Tunisia, Thesis supervisor |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
20/03/2025 |
Translation from the French to the English |
Public Enquiries, Souad, Chalbi, Prof., souad_chelbi@yahoo.fr, souad_chelbi@yahoo.fr, +2720002211, Mohamed Karoui Street , Sousse, 4002, Tunisia, Thesis supervisor |
Public Enquiries, Souad, Chelbi, Prof., souad_chelbi@yahoo.fr, , +2720002211, Mohamed Karoui Street., Sousse, 4002, Tunisia, Thesis supervisor |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
19/03/2025 |
Translation from the French to the English language |
Scientific Enquiries, Ghada, Saad, Dr., ghada.saad6587@gmail.com, , +2758130600, Rue Mohamed Karoui , Sousse, 4002, Tunisia, Codirecteur de these |
Scientific Enquiries, Ghada, Saad, Dr., ghada.saad6587@gmail.com, ghada.saad6587@gmail.com, +2758130600, Mohamed Karoui Street., Sousse, 4002, Tunisia, supervisor of the thesis |
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Section Name
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Field Name
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Date
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Reason
|
Old Value
|
Updated Value
|
| Reporting |
IPD description |
20/03/2025 |
translate from the French to the English language |
Une fois le projet achevé, les auteurs partageront les données par le biais d'un dépôt de données. Les résultats du projet seront communiqués par le biais de publications dans des revues à comité de lecture. |
Once the project is completed, the authors will share the data through a data repository. The project results will be communicated through publications in peer-reviewed journals. |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
IPD-Sharing time frame |
20/03/2025 |
translate from the French to the English language |
juin 2025 |
June 2025 |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
Key access criteria |
20/03/2025 |
translate from the French to the English language |
Accès ouvert
|
Open Access |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
Results Available |
20/03/2025 |
translate from the French to the English language |
No |
Yes |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
Result Summary Pdf file1 |
20/03/2025 |
translate from the French to the English language |
|
33443_24899_1045.pdf |