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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120260
• Other study ID #: ND-201
• Status: Completed
• Phase: N/A
• First received: April 15, 2017
• Last updated: March 28, 2018
• Start date: June 15, 2017
• Est. completion date: November 27, 2017

Study information

• Verified date: March 2018
• Source: Novindiet Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 27, 2017
• Est. primary completion date: October 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Other:
• Diet
Intervention 'Diet+ short sleep versus normal sleep

Locations

Country	Name	City	State
Iran, Islamic Republic of	NovinDiet Clinic	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Novindiet Clinic	Tehran University of Medical Sciences, University of Nottingham

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	kg	12 Weeks
Secondary	Body mass index reduction	kg/m2	12 Weeks
Secondary	Fasting plasma glucose level	mmol/l	12 Weeks
Secondary	lipid profiles	mmol/l	12 Weeks
Secondary	Insulin resistance (HOMA)	score	12 Weeks
Secondary	liver enzymes (SGOT, SGPT)	U/l	12 Weeks