Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305868714755 Date of Approval: 22/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Group therapeutic education versus individual education of type 2 diabetics: what impact on dietary practices?
Official scientific title Group therapeutic education versus individual education of type 2 diabetics: what impact on dietary practices?
Brief summary describing the background and objectives of the trial The degree of follow-up of lifestyle rules by diabetics is insufficient. This is the result of different factors : - On the one hand, the place of food and culinary pleasure is central among our patients; for many of them, it is one of the rare joyful moments in everyday life. However, the classic dietary prescriptions are in principle restrictive, and deprive diabetics of a certain number of these pleasures. - On the other hand, food is an important element of social sharing, both on a daily basis and at particular events. Restricting food consumption, especially that associated with our holidays, contributes to isolating the diabetic and marginalizing him. - Likewise, food has the characteristic of being varied; we often get tired of the same meals. However, the classic dietary prescription often offers only a small variety of culinary choices. Group therapeutic education, within the framework of a structured program, is a concept that has been studied and practiced for a long time. It offers a different approach to individual education, and it can offer solutions to the barriers to following dietary rules, thus, improving dietary compliance. We propose to evaluate the impact of a group therapeutic education on the dietary practices of type 2 diabetics.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 14/05/2023
Actual trial start date 14/05/2023
Anticipated date of last follow up 02/06/2023
Actual Last follow-up date 02/06/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group education Three sessions of 45 minutes each a week A three sessions group nutrition education, of 45 minutes each, performed by the nutritionnist, and the investigator. 28
Control Group Individual education three sessions of 30-45 minutes each a week Individual nutrition education sessions, of 30-45 minutes each, performed by the nutritionist and the investigator 28 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adult type 2 diabetic patients (18 to 65 years old) on insulin for at least 6 months admitted to hospital • Having on the dietary survey an excess of caloric intake • Informed consent • Patients whose cognitive status hinders relevant data collection • Patients unable to follow a therapeutic education program or to apply its teachings (patient dependent on others, sensory deficit without device, etc.) • Patients who withdrew their consent from the study Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/02/2023 Ethics committee of the National Institute of Nutrition and Food technologies
Ethics Committee Address
Street address City Postal code Country
11, Jebel Lakhdhar Street Tunis 1007 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the percentage drop in caloric balance drop, taken from food survey data. 15 days
Secondary Outcome Score of the dietetic knowledge questionnaire 15 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Institute of Nutrition and Food technology 11 Jebel Lakhdhar Street Tunis 1007 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Gharbi Radhouen 1 Palestine street Menzel Bourguiba Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institue of Nutrition and Food Technology 11 Jebel Lakhdhar Street Tunis 1007 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Gharbi Radhouen radhouen.gharbi@fmt.utm.tn 0021626857246 1-Palestine Street
City Postal code Country Position/Affiliation
Menzel Bourguiba 7050 Tunisia Assistant Professor
Role Name Email Phone Street address
Principal Investigator Ben Tara Bakhta Bakhta24bentara@gmail.com 0021622069693 Bardo
City Postal code Country Position/Affiliation
Tunis Tunisia Nutritional science student
Role Name Email Phone Street address
Public Enquiries Kammoun Ines ines.kammoun@fmt.utm.tn 0021698352605 El Manar
City Postal code Country Position/Affiliation
Tunis Tunisia Professor
Role Name Email Phone Street address
Principal Investigator Maatki Chiraz Maatki.Chiraz@gmail.com 0021653413103 El Menzah
City Postal code Country Position/Affiliation
Tunis Tunisia Dietetician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We, members of the research team, declare that all individual participant data collected for the study will be available after deidentification Informed Consent Form,Study Protocol 6 months after trial completion Mail Dr Gharbi Radhouen via his institutionnal mail : radhouen.gharbi@fmt.utm.tn via a formal request . All data collected will be available in addition to study protocol and informed consent Form. The access request is open, but must be justified .
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information