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.: PACTR202301674821174 Date of Approval: 20/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title time restricted eating and high intensity functional training in management of obesity and overweight
Official scientific title the combined and isolate effect of time restricted eating and high intensity functional training (HIFT) on physical postural balance ,body composition ,metabolic and biochemical responses in women with obesity.
Brief summary describing the background and objectives of the trial high intensity functional training has been shown to be an effective modality for improving health and an efficient alternative in time management compared to traditional continuous exercise in the management of overweight and obesity. Moroever, several studies have highlighted the importance of time restricted eating regimen on health due to its convenience and benefits for improving body composition, insulin sensitivity, fat oxidation and many other biochemical, cardiovascular and metabolic adaptations in women with obesity . The objective of this study was to examinethe combined and isolate effect of time restricted eating and high intensity functional training (HIFT) on physical postural balance ,body composition ,metabolic and biochemical responses in women with obesity.
Type of trial RCT
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 Physical activity and nutrition
Anticipated trial start date 01/10/2021
Actual trial start date 01/10/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 94
Actual target sample size (number of participants) 84
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 Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Time restricted eating 12 weeks Time restricted eating 12 weeks fasting period of 16 h (16:00 pm to 8:00 am) and ad libitum eating ≤ 8 h (8:00 am to 16:00 pm). 20
Experimental Group high intensity functional training HIFT 3 days per week 12 weeks HIFT during the fasting window (17:00 pm). 24
Experimental Group combined group 3 days/week 12 weeks fasting 16 h and performed exercice during the fasting window 20
Control Group Experimental Group no exercise 12 weeks the group were not involved in a physical training program or diet intervention 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Aged 18–45 years old -BMI higher than 30 kg/m2 - waist circumferences (WC) -higher than 80 cm -able to engage in physical activity -had not followed a structured training program in the previous 6 months -had been weight stable for 3 months prior to the study -Pregnant -breastfeeding within 24 weeks of study beginning -having cardiovascular disease -having a diagnosis of diabetes - using regular medications -smokers - who were undergoing weight loss treatment - habitual eating window <12 hours/day Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
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 28/09/2019 The south institutional human research ethics committee
Ethics Committee Address
Street address City Postal code Country
Road Manzel Cheker sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Body composition - Biochemical reponses ( glucose, lipid profile, ) ,performances physique Before and after intervention
Secondary Outcome sleep quality - temperature - Energy intake - Heart rate variability Before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LADY FITNESS rue jamel abdenaceur rue sfax ksour essef 5180 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Fatouma Bourguiba University Hospital Street1er juin 1955 5000 Monastir Monastir 5000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Laboratory molecular bases of human pathology fatouma bourguiba of Monastir Street 1er juin 1955 Monastir 5000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Omar Hammouda Road sidi mansour sfax 3027 Tunisia
Mouhamed Fadhel Najjar Monastir Monastir 5000 Tunisia
Fadwa Naffati Monastir Monastir 5000 Tunisia
Rami Maloul sfax Sfax 3027 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Hammouda Omar_hammouda86@yahoo.fr +21652785747 Road sidi mansour
City Postal code Country Position/Affiliation
sfax Tunisia Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Sfax University Tunisia
Role Name Email Phone Street address
Public Enquiries Fadwa Neffeti neffati.fadoua@72gmail.com 97255016 Monastir
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia Biochemistry Department
Role Name Email Phone Street address
Scientific Enquiries Mohamed Fadhel Najjar najjar.fadhel@rns.tn 0021697255016 Monastir
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia The Research Unit of the of BiochemistryToxicology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that will be generated from this study will be shared on request after deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol 2 years controlled
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