Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Caloric Restriction, weight loss, sleep
Eligibility Criteria
Inclusion Criteria:
- Must be female
- Must have < 7 hour sleep per night
- Must be 18-45 years of age.
- Must have Body mass index (BMI) between 27-35 kg/ m².
- Must be able to have moderate exercise.
- Must be interested to have weight loss.
Exclusion Criteria:
- Participating in a research project involving weight loss or physical activity in the previous six months.
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- Taking medication that could affect metabolism or change body weight.
- Report heart problems, chest pain, and cancer within the last five years.
- Smoking
- Menopause
- Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Sites / Locations
- NovinDiet Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Short Sleep
Normal Sleep
Arm Description
Diet+ have 5 hour sleep at night (SS)
Diet+ have 7-8 hour sleep at night (NS)
Outcomes
Primary Outcome Measures
weight loss
kg
Secondary Outcome Measures
Body mass index reduction
kg/m2
Fasting plasma glucose level
mmol/l
lipid profiles
mmol/l
Insulin resistance (HOMA)
score
liver enzymes (SGOT, SGPT)
U/l
Full Information
NCT ID
NCT03120260
First Posted
April 15, 2017
Last Updated
March 28, 2018
Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03120260
Brief Title
Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program
Official Title
Comparing the Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program: A 12 Week Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the present study is to evaluate the effect of sleep duration on weight loss of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The investigators aim is to compare the effects of short term sleep duration with normal sleep duration with respect to body weight (and abdominal adiposity).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Caloric Restriction, weight loss, sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short Sleep
Arm Type
Experimental
Arm Description
Diet+ have 5 hour sleep at night (SS)
Arm Title
Normal Sleep
Arm Type
Experimental
Arm Description
Diet+ have 7-8 hour sleep at night (NS)
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
Intervention 'Diet+ short sleep versus normal sleep
Primary Outcome Measure Information:
Title
weight loss
Description
kg
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Body mass index reduction
Description
kg/m2
Time Frame
12 Weeks
Title
Fasting plasma glucose level
Description
mmol/l
Time Frame
12 Weeks
Title
lipid profiles
Description
mmol/l
Time Frame
12 Weeks
Title
Insulin resistance (HOMA)
Description
score
Time Frame
12 Weeks
Title
liver enzymes (SGOT, SGPT)
Description
U/l
Time Frame
12 Weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be female
Must have < 7 hour sleep per night
Must be 18-45 years of age.
Must have Body mass index (BMI) between 27-35 kg/ m².
Must be able to have moderate exercise.
Must be interested to have weight loss.
Exclusion Criteria:
Participating in a research project involving weight loss or physical activity in the previous six months.
Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
Taking medication that could affect metabolism or change body weight.
Report heart problems, chest pain, and cancer within the last five years.
Smoking
Menopause
Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Facility Information:
Facility Name
NovinDiet Clinic
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program
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