Effects of Late Dinner Against Early Dinner on Weight Los... | NCT03129841

Studies
Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women

NCT03129841

Sponsor

Novindiet Clinic

Status

Completed

Last Update Posted

Oct 28, 2019Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Obesity
Overweight

Interventions

Early dinner+Diet
Late dinner+Diet

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Oct 5, 2017Actual

Completion Date

Nov 18, 2017Actual

First Submitted Date

Apr 15, 2017

First Submission Date that Met QC Criteria

Apr 22, 2017

First Posted Date

Apr 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2019

Last Update Posted Date

Oct 28, 2019Actual

Name	Class
University of Nottingham	OTHER
Tehran University of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the present study is to test whether late eating dinner could affect the amount of weight loss in healthy obese women in a weight-loss program.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
early dinner+Diet	Experimental		Behavioral: Early dinner+Diet
late dinner+Diet	Experimental		Behavioral: Late dinner+Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early dinner+Diet	Behavioral	Subjects are asked to eat dinner meals between 7:00- 7:30 PM in the ED group, while they are on a multidisciplinary weight loss plan for 12 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight loss	kg	12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
waist circumference	cm	12 Weeks
fasting plasma glucose	mmol/L	12 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight
D015431	Weight Loss

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided