search
Back to results

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
Novindiet Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Caloric Restriction, weight loss, sleep

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
April 15, 2017
Last Updated
March 28, 2018
Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences
search

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

Learn more about this trial

Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program

We'll reach out to this number within 24 hrs