Protocol summary

Summary
The role of physical activity with diet to lose weight is clear . The purpose of this study was to evaluate the effect of high and low frequency of physical activity on weight loss in healthy obese and overweight women . For this purpose, 60 eligible healthy obese and overweight women(Body mass index 27-35 kg/m2), age 18-50 years, no regular exercise,no self-report of acute or chronic disease, no evidence of amenorrhea were selected and divided into two groups (n=30); 1) physical activity with high frequency ( 6 days / 50 min ) and 2 ) physical activity with low frequency ( 3 days / 100 min ). Participants are involved in other weight loss programs with dietary regimen intervention as a component, are anemic (Hematocrit < 34%), report total cholesterol > 300 mg/dl, report triglyceride > 350 mg/dl will be excluded. During the study period, all of the participants will follow a diet with caloric restriction ( 500 kcal less than BMR). Before and after the study, blood parameters including triglycerides, total cholesterol, HDL, LDL, fibrinogen, and HOMA-IR are measured. Weight and waist circumference is measured at the beginning of the study and every two weeks . Physical activity adherence is controlled by pedometer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402157754N4
Registration date: 2014-03-11, 1392/12/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-11, 1392/12/20
Registrant information
Name
Leila Shafiei Neek
Name of organization / entity
Faculty of Physical Education and Sport Sciences, University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 9952
Email address
shafieineek@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Novin Diet Clinic (Dr. Farshchi)
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of High and Low Frequency of Physical Activity on Long Term Efficacy of Weight Loss in Healthy Overweight and Obese Women
Public title
Effects of exercise on weight loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Body mass index 27-35 kg/m2;Age 18-50 years; No regular exercise (> 1 bout of exercise/wk or participation in any sporting activities > 1 hr/wk.); No self-report of acute or chronic disease (diabetes, heart diseases, and joint problems in particular); For females;No evidence of amenorrhea (Regular menstrual cycles of 21-35 days). Exclusion Criteria: Sedentary or are involved with other weight loss programs with dietary regimen intervention as a component; Anemia (Hematocrit < 34%); Total cholesterol > 300 mg/dl; Triglyceride > 350 mg/dl.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Digestive Disease Reaserch Institute
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Postal code
Approval date
2014-01-28, 1392/11/08
Ethics committee reference number
FWA00001331

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Weight
Timepoint
At the beginning of the study and every two weeks
Method of measurement
Scale

2

Description
Waist circumference
Timepoint
At the beginning of the study and every two weeks
Method of measurement
meter

Secondary outcomes

1

Description
Triglyceride
Timepoint
At the beginning of study and after 6 month
Method of measurement
Blood testing

2

Description
Total cholesterol
Timepoint
At the beginning of study and after 6 month
Method of measurement
Blood testing

3

Description
HDL
Timepoint
At the beginning of study and after 6 month
Method of measurement
Blood testing

4

Description
LDL
Timepoint
At the beginning of study and after 6 month
Method of measurement
Blood testing

5

Description
HOMA-IR
Timepoint
At the beginning of study and after 6 month
Method of measurement
Blood testing

6

Description
Fibrinogen
Timepoint
At the beginning of study and after 6 month
Method of measurement
Blood testing

Intervention groups

1

Description
walking with low frequency (3 days a week and a day, 100 minutes, 300 minutes per week) followed a restiricted diet (500 calorie less than BMR). The participants are asked to record their daily step count. Diet and physical activity will follow every two weeks.
Category
Behavior

2

Description
walking with high frequency (5 days per week and a daily 50-minute, 300 minutes per week) followed a restiricted diet (500 calorie less than BMR). The participants are asked to record their daily step count. Diet and physical activity will follow every two weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Novin Diet Clinic
Full name of responsible person
Dr.Hamidreza Farshchi
Street address
No.5, 4th Floor, Nikan Bldg., Shariati Ave.,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Novin Diet Clinic
Full name of responsible person
Dr. Hamidreza Farshchi
Street address
No.5, 4th Floor, Nikan Bldg., Shariati Ave.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Novin Diet Clinic
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Novin Diet Clinic
Full name of responsible person
Dr.Seyedeh Ameneh Majd
Position
Pharmacologist
Other areas of specialty/work
Street address
No.5, 4th Floor, Nikan Bldg., Shariati Ave.,
City
Tehran
Postal code
Phone
+98 21 2226 3002
Fax
Email
amameneh@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Novin Diet Clinic
Full name of responsible person
Dr.Hamidreza Farshchi
Position
Clinical Nutritionist & Metabolism
Other areas of specialty/work
Street address
No.5, 4th Floor, Nikan Bldg., Shariati Ave.,
City
Tehran
Postal code
Phone
+98 21 2226 3002
Fax
Email
hrfarshchi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Novin Diet Clinic
Full name of responsible person
Leila Shafiei Neek
Position
PhD student of exercise physiology
Other areas of specialty/work
Street address
No.5, 4th Floor, Nikan Bldg., Shariati Ave.,
City
Tehran
Postal code
Phone
+98 21 2226 3002
Fax
Email
shafieineek@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...