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

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Other: Diet

• Registration Number: NCT03120260
• Lead Sponsor: Novindiet Clinic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-15
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-19
• Study Start: 2017-06-15
• Primary Completion: 2017-10-02
• Study Completion: 2017-11-27
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Sleep	Diet	Diet+ have 7-8 hour sleep at night (NS)
Short Sleep	Diet	Diet+ have 5 hour sleep at night (SS)

Primary Outcome Measures

Name	Time	Method
weight loss	12 Weeks	kg

Secondary Outcome Measures

Name	Time	Method
lipid profiles	12 Weeks	mmol/l
Fasting plasma glucose level	12 Weeks	mmol/l
Body mass index reduction	12 Weeks	kg/m2
Insulin resistance (HOMA)	12 Weeks	score
liver enzymes (SGOT, SGPT)	12 Weeks	U/l

Trial Locations

Locations (1)

NovinDiet Clinic; 🇮🇷 Tehran, Iran, Islamic Republic of