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.: PACTR201911530577414 Date of Approval: 21/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Induced Food aversion technique; unpreceded intervention to treat obesity
Official scientific title Induced Food aversion technique; unpreceded intervention to treat obesity
Brief summary describing the background and objectives of the trial Overweight and obesity are defined as abnormal or excessive fat accumulation that presents a risk to health. A crude population measure of obesity is the body mass index (BMI), a person’s weight (in kilograms) divided by the square of his or her height (in meters). A person with a BMI of 30 or more is generally considered obese. A person with a BMI equal to or more than 25 is considered overweight (Organization, 2019). Obesity is a complex, multifactorial, and largely preventable disease, affecting, along with overweight, over a third of the world’s population today (Ng et al., 2014; Stevens et al., 2012). If secular trends continue, by 2030 an estimated 38% of the world’s adult population will be overweight and another 20% will be obese. (Kelly, Yang, Chen, Reynolds & He, 2008). In spite of the long list of interventions to manage obesity worldwide prevalence of obesity has nearly tripled between 1975 and 2016 (Obesity and overweight, WHO 2018). In Egypt, according to the study published in the New England Journal of Medicine, Egypt has the highest percentage of obese adults worldwide. Around 19 million Egyptians, or 35 percent of the adult population, are obese; this is the highest rate across the globe.(Collaborators, 2017) The morbidity effect of obesity is manifested in many body parts: brain (stroke); throat (sleep apnea, snoring); lungs (lung disease, asthma, pulmonary blood clots); heart (heart disease, diabetes, abnormal lipid profile, high blood pressure); liver (liver disease, fatty liver, cirrhosis); pancreas (pancreatitis); gall bladder (gallstones); uterus (female disorders, abnormal periods, infertility); knees (arthritis); calves (inflamed veins, often with blood clots); feet (gout); breast, uterus, colon, esophagus, pancreas, kidney, prostate (cancer) (CDC, 2019). Although the remedies seem very simple, decrease energy intake and increase energy expenditure, still very few are able to adhere to this equation. Introducing a novel too
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 21/12/2019
Actual trial start date 01/12/2019
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date 29/02/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 50
Recruitment status Recruiting
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group food aversion 3 months The intervention is based on the conditioning theory, patients experience tingling and soreness sensation which is acknowledge in physiotherapy machine used for faradic and galvanic current production for fat redistribution (a monophasic square wave, output voltage 75Vpp @ 500 Ohm full power load, with pulse width 350 Microseconds & frequency 85 Hz from a body toner device). This sensation will be used as a condition reflexes that to be induced while patients are given the preferred diet that is incriminated in inducing obesity (one salty on sweet food). This will be repeated for three sessions per week for each food item until patients reject this type of food. Each session will last for 20 minutes. The intervention duration is 3 months, so the intake of 4 types of foods most probably responsible for weight gain (based on dietary history) would be stopped by the end of the study. 25
Control Group physical activity and dietary management 3 months dietary management advise adopting physical activity 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Target population: a. Overweight patients with body mass index above 25 and obese patients whose BMI equal or above 30 kg/m2. b. Age >18 years. Exclusion criteria: are excluded if they have: a. On medical treatment for weight reduction. b. End-stage renal disease and on dialysis. c. Decompensated liver disease or heart failure according to New York Heart Association (NYHA) grade III or IV. d. Handicapped: cerebrovascular strokes, lower limb amputation advanced retinopathy/ blindness. e. Gestational diabetes or breastfeeding mothers. f. Dementia. g. Already enrolled in other weight control programs. h. Endocrinal causes of obesity (Cushing disease, hypothyroidism, Adult: 19 Year-44 Year,Aged: 65+ Year(s),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 12/11/2019 High Institute of Public Health
Ethics Committee Address
Street address City Postal code Country
165 El-Horreya Avenue, Alexandria 21928 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome induction of food aversion. 12 weeks
Secondary Outcome - Weight reduction. 12 week
Secondary Outcome - Normalization of lipid profile. 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nutrition Medical Center 8 English Church Street,Stanley Alexandria 21599 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tarek Kamal Reda 50 Abdel Aziz Fahmy Street, Stanley Alexandria 21599 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nutrition Medical Center 8 English Church Street, Stanley Alexandria 21599 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Abdelrahman Omran Amrya Sharqway Mosque st Alexandria 23511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Reda tarekreda@hotmail.com +201222382990 8 English Church Street, Stanley Alexandria
City Postal code Country Position/Affiliation
Alexandria 21599 Egypt Ministry of Health and population
Role Name Email Phone Street address
Scientific Enquiries Ramy Ghazy ramyghazy1986@hotmail.co +201274741084 Agamy, Bitash, Mohamed El-Lithy St in front of Agamy Water Company
City Postal code Country Position/Affiliation
Alexandria 21928 Egypt High Institute of Public Health
Role Name Email Phone Street address
Public Enquiries Ramy Ghazy ramyghazy1986@hotmail.com +201274741084 Egypt. 165 El-Horreya Avenue
City Postal code Country Position/Affiliation
Alexandria 21928 Egypt High Institute of Public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial and after deidentification will be available. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD and any additional supporting information will become available within 6 months of publication and would be available forever. AlI IPD and any additional supporting information will be shared. With whom: researchers who provide a methodologically sound proposal. Types of analyses: For individual participant data (metanalysis). Mechanism: the proposals should be submitted to ramyghazy1986@hotmail.com.to gain access data requestors needs to sigh data access agreement. Who will review requests: Ramy Ghazy Criteria for reviewing requests: Clinical trial (registered)
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