Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001732178
Ethics application status
Approved
Date submitted
26/09/2019
Date registered
9/12/2019
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results information initially provided
9/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Caloric Restriction Associated with Low-Impact Aerobics and Strength Training Exercises on Body Composition and Cardiovascular Diseases Risk Factors among Obese Students with Metabolic Syndrome
Scientific title
Effects of Caloric Restriction Associated with Low-Impact Aerobics and Strength Training Exercises on Body Composition and Cardiovascular Diseases Risk Factors among Obese Students with Metabolic Syndrome
Secondary ID [1] 299989 0
None
Universal Trial Number (UTN)
U1111-1241-1159
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 314610 0
Metabolic syndrome 314611 0
Caloric restriction 314612 0
aerobic training 314613 0
Resistance exercises 314614 0
Diet and Nutrition 315228 0
Condition category
Condition code
Diet and Nutrition 312945 312945 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 312946 312946 0 0
Metabolic disorders
Cardiovascular 312947 312947 0 0
Other cardiovascular diseases
Public Health 312948 312948 0 0
Health promotion/education
Diet and Nutrition 313536 313536 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Enhanced Lifestyle Counseling
Each participant was offered one education session/month during 4 months with 30-60 min in length each one and conducted by lifestyle coaches, who were trained and certified in intervention before the experiment began. Participants were encouraged to produce a weight loss between 0.5 and 1%/week of the own weight by reducing calories intake and increasing energy expenditure. Coaches act to reinforce motivation and sustain the weight reduction programs by resolving problems derived from self-monitoring, behavioural modifications, controlling stimulus, physical training, and appearance.
2. Dietary Protocol
A dietician established a balanced and personalized dietary restriction program for each subject based on an initial dietary behavior assessment (the amounts of food and fluid consumed by each subject for a week and the relevant timestamps were recorded). Each individual’s diet was designed according to their dietary habits and other selected foods with low glycemic indices, which were mainly fruits, vegetables, and whole grains. Fast foods, sugar-sweetened drinks, energy drinks, French fries, potato chips, cake, donuts, and sweets were to be avoided. Subjects' targeted daily caloric intake deficit was approximately 500 kcal/day, and diets were composed of approximately 15-20% proteins and 25-30% lipids, with carbohydrates representing the remainder of the caloric intake. A software for food coaching was used to calculate participants' food intake and composition (S.C.D.A. Nutrisoft, Le Hallier 37390 Cerelles, France).
3. Physical activity
The program includes three sessions per week over a 12-week period of Low-impact aerobics (LIA), and resistance exercises performed on machines or with free weights. Each session involved a 5- to 10-minute warm up including walking and stretching exercises, an exercise session, and a 5- to 10-minute cooldown involving breathing and stretching exercises. The exercise session was divided into two sections (section I: LIA; section II: resistance exercises). The LIA section lasted between 30 and 40 min and involved rhythmic, non-jumping exercises, to elevate the heart rate and improve circulation without jarring knees or worsening back pain: walking on treadmill and/or moving on elliptical and/or a workout regimen combining taekwondo and boxing (TAE BO). The initial intensity was set at 65% of the theoretical heart rate max (200 - age in years), with monthly incrementation of 5%. The resistance training section involved a circuit of selected six exercises performed on machines or with free weights involving most muscle segments and groups. Each exercise was performed for three sets of 8-12 repetitions each with a 1-min rest between sets and a 3-min rest between exercises. The initial training load was set at 60% 1RM and was increased every four weeks by 5% for the upper limb exercises and 10% for the lower limb exercises. The 1-RM values were predicted from the 4-6-RM tests performed at the first workout of the first week. Professional trainers supervised all training sessions, and a polarity analyzer (Polar Electro Oy, Finland) was used to control heart rates throughout the session.
Intervention code [1] 315672 0
Prevention
Intervention code [2] 315673 0
Treatment: Other
Intervention code [3] 315674 0
Lifestyle
Comparator / control treatment
The comparator group received caloric restriction alone, however, the second group was subjected to caloric restriction associated with aerobic+resistance training exercises.
Control group
Active

Outcomes
Primary outcome [1] 321536 0
Changes in weight, waist circumference (WC), body mass index (BMI), percentage of body fat (PBF), and waist-to-hip ratio (WHR) determined by bioelectrical impedance analysis using a body composition analyzer with an Ultrasonic Anthropometer (ACCUNIQ BC360, SELVAS Healthcare, Inc., Republic of Korea).
Timepoint [1] 321536 0
Baseline: done during the two weeks preceding the intervention, for all participants that accept to participate in our study.
16 weeks after intervention commencement, for all obese participants diagnosed with metabolic syndrome.
Primary outcome [2] 321988 0
Changes in the level of metabolic syndrome components: This is a composite primary outcome. The diagnosis of metabolic syndrome is based on the existence of three or more of the following conditions: central obesity, high blood pressure, high fasting blood glucose, hypertriglyceridemia, and low level of high density lipoprotein cholesterol.
Participant blood pressures (BPs) were measured in duplicate using the right arm, and using a wireless BP monitor (iHealth Labs Inc., Canada). Fasting Blood Glucose (FBG) concentrations were measured with a VITROS GLU Slide method using VITROS GLU Slides and VITROS Chemistry Products Calibrator Kit 1 on VITROS Chemistry Systems (Ortho-Clinical Diagnostics, Inc. Rochester, NY, USA). Total Cholesterol (TC) and Triglycerides (TG) concentrations were determined enzymatically on Vitros 250 chemistry analyzer (J&J/Ortho Clinical Diagnostics, Rochester, NJ, USA). High density lipoproteins cholesterol (HDL-c) level was determined by a precipitation assay with dextran sulfate on Vitros 250 chemistry analyzer (J&J/Ortho Clinical Diagnostics, Rochester, NJ, USA).
Timepoint [2] 321988 0
Baseline: done during the three days before the beginning of the intervention, for all participants with a BMI between 30 and 40 kg.m-2 .
16 weeks after intervention commencement, for all obese participants diagnosed with metabolic syndrome.
Primary outcome [3] 322144 0
Energy input assessed using a four day weighed dietary record. Each participant was requested to record dietary intake over two weekdays and two weekend days in a diary
Timepoint [3] 322144 0
Seven days before the intervention commencement, for all participants with BMI between 30 and 40 kg/m2 and.
Secondary outcome [1] 375275 0
Changes in Low density lipoproteins cholesterol (LDL-c) concentrations determined by direct assay by Polymedco (Cortlandt Manor, NY) for CX3/7 (Beckman, Fullerton, CA), All measurements were performed at the KFU Medical Center Laboratory.
Timepoint [1] 375275 0
Baseline: done during the three days before the beginning of the intervention, for all participants with a BMI between 30 and 40 kg.m-2 .
16 weeks after intervention commencement, for all obese participants diagnosed with metabolic syndrome.
Secondary outcome [2] 376931 0
Changes in very low density lipoproteins cholesterol (VLDL-c) estimated by dividing the triglyceride value by 5.
Timepoint [2] 376931 0
Baseline: done during the three days before the beginning of the intervention, for all participants with a BMI between 30 and 40 kg.m-2 .
16 weeks after intervention commencement, for all obese participants diagnosed with metabolic syndrome.

Eligibility
Key inclusion criteria
sedentary lifestyle (walking less than 1.5 miles daily), a BMI between 30 and 40 kg.m-2, and a lack of any contraindications regarding physical exercises according to the American College of Sports Medicine guidelines.
Minimum age
19 Years
Maximum age
24 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Completing less than of 80% of the intervention
Diagnosed without metabolic syndrome

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Considering the effect size around 0.6SD for the smallest-powered designed comparison, we calculated a sample size of 291 participants to allow 80% power for comparisons (overall a = .05 overall). Calculated for a 20% dropout rate, 340 participants were randomized for potential participation and an E- mail was sent to each one. In all, 299 individuals have provided a positive response and have been subjected to the assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization scheme consists of an arbitrary introduction of all students from the same college to one of the two intervention groups. Each group acts separately from the other one, and a prospective single-blinded was adopted for this study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In all, 299 male students from four colleges of King Faisal University (KFU), were evaluated for potential enrollment. Participants who met the eligibility criteria (N = 64) were screened for MetS, and participants diagnosed with this disease (N = 23) were randomly introduced to a dieting program (the dieting group, or DG: N = 9) or to dieting associated with a supervised physical training program (the diet and training group, or DTG: N = 14). The Gaussian distribution for independent parameters was assessed by a Shapiro-Wilk test. Changes expressed in units (X2 – X1) and in percentage (X2 – X1)*100 / X1 were calculated and all results were presented as mean ± standard deviation (SD). Unpaired t-test was used to compare the between groups values at baseline, after interventions and changes. A paired t-test was employed to assess the statistical significance of intra-group modifications after interventions. Pearson's correlation coefficient (r) was used to assess the linear relationships, which exist between the studied variables. Analyses were performed using the SPSS software, version 16.0 (IBM Inc., Armonk, NY, USA), and differences were considered significant at p < 0.05 (two-sided).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2017
Date of last participant enrolment
Anticipated
Actual
15/11/2017
Date of last data collection
Anticipated
Actual
30/04/2018
Sample size
Target
299
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 21885 0
Saudi Arabia
State/province [1] 21885 0
Al-Hasa

Funding & Sponsors
Funding source category [1] 303933 0
University
Name [1] 303933 0
Deanship of Scientific Research, King Faisal University
Country [1] 303933 0
Saudi Arabia
Primary sponsor type
University
Name
Laboratory of Medical Center, King Faisal University
Address
King Faisal University, 31982 Al-Hassa, Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 304084 0
University
Name [1] 304084 0
Physical Education Department, College of Education, King Faisal University
Address [1] 304084 0
College of Education, King Faisal University, 31982 Al-Hassa, Saudi Arabia
Country [1] 304084 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304429 0
Ethical Committee of the Deanship of Scientific Research of King Faisal University (project number 186020, Saudi Arabia).
Ethics committee address [1] 304429 0
Deanship of Scientific Research, King Faisal University.
Ethics committee country [1] 304429 0
Saudi Arabia
Date submitted for ethics approval [1] 304429 0
01/03/2017
Approval date [1] 304429 0
30/09/2017
Ethics approval number [1] 304429 0

Summary
Brief summary
Subjects
Sedentary overweight or obese men will be evaluated for potential participation. Exclusion criteria are angina pectoris during the intervention period, myocardial infarction, heart failure, coronary artery disease, uncontrolled hypertension, kidney failure, neurological limitations to exercise. A compliance with the training program of 80% will be also listed as a criterion for completing the study (Schjerve et al., 2008). Subjects who will meted the eligibility criteria and agreed to participate will be assigned to caloric restriction alone or caloric restriction associated to Low-Impact Aerobic combined to a Strength Training program. All participants will be informed about possible risks and benefits of the exercises, and will signed a consent before beginning of the study.
Anthropometric measurements including Body height, body mass, waist and hip circumference, and 04 Skinfolds thicknesses will be measured for each subject.
Physical Fitness variables including aerobic fitness (AF), speed and agility (SA), explosive power of the lower limbs, abdominal muscle endurance (AME), and the flexibility of the lower back and hamstrings, and metabolic syndrome components will be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96926 0
Dr Mohamed SAID
Address 96926 0
Physical Education Department, College of Education, King Faisal University
Country 96926 0
Saudi Arabia
Phone 96926 0
+966541993997
Fax 96926 0
+966541993997
Email 96926 0
[email protected]
Contact person for public queries
Name 96927 0
Dr Mohamed SAID
Address 96927 0
Physical Education Department, College of Education, King Faisal University
Country 96927 0
Saudi Arabia
Phone 96927 0
+966541993997
Fax 96927 0
+966541993997
Email 96927 0
[email protected]
Contact person for scientific queries
Name 96928 0
Dr Mohamed SAID
Address 96928 0
Physical Education Department, College of Education, King Faisal University
Country 96928 0
Saudi Arabia
Phone 96928 0
+966541993997
Fax 96928 0
+966541993997
Email 96928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial.
When will data be available (start and end dates)?
Immediately following publication and no end date determined.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]; [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.