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

NCT ID: NCT03120260

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2017-11-27

Brief Summary

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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

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Short Sleep

Diet+ have 5 hour sleep at night (SS)

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

Intervention 'Diet+ short sleep versus normal sleep

Normal Sleep

Diet+ have 7-8 hour sleep at night (NS)

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

Intervention 'Diet+ short sleep versus normal sleep

Interventions

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Diet

Intervention 'Diet+ short sleep versus normal sleep

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role collaborator

Novindiet Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NovinDiet Clinic

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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ND-201

Identifier Type: -

Identifier Source: org_study_id

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