Skip to main content
OpenTrials
Completed

NCT Number: NCT03120260

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NovinDiet Clinic

Tehran, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet

Other

Intervention 'Diet+ short sleep versus normal sleep

Primary outcomes

  1. weight loss

    Time frame: 12 Weeks

    kg

Secondary outcomes

  1. Body mass index reduction

    Time frame: 12 Weeks

    kg/m2

  2. Fasting plasma glucose level

    Time frame: 12 Weeks

    mmol/l

  3. lipid profiles

    Time frame: 12 Weeks

    mmol/l

  4. Insulin resistance (HOMA)

    Time frame: 12 Weeks

    score

  5. liver enzymes (SGOT, SGPT)

    Time frame: 12 Weeks

    U/l

Sponsors and collaborators

Lead sponsor

Novindiet Clinic

Other

Collaborators

  • Tehran University of Medical Sciences
  • University of Nottingham

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2017
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.