NCT03129841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2017

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

April 15, 2017

Last Update Submit

October 24, 2019

Conditions

Keywords

weight lossdietary patternlate dinnerearly dinner

Outcome Measures

Primary Outcomes (1)

  • weight loss

    kg

    12 Weeks

Secondary Outcomes (7)

  • waist circumference

    12 Weeks

  • fasting plasma glucose

    12 Weeks

  • insulin level

    12 Weeks

  • insulin resistance (HOMA-IR)

    12 Weeks

  • glycosylated hemoglobin (HbA1c)

    12 Weeks

  • +2 more secondary outcomes

Study Arms (2)

early dinner+Diet

EXPERIMENTAL
Behavioral: Early dinner+Diet

late dinner+Diet

EXPERIMENTAL
Behavioral: Late dinner+Diet

Interventions

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.

Also known as: ED
early dinner+Diet

Subjects are asked to eat their dinner meal between 10:30-11:00PM, while they are on a multidisciplinary weight loss plan for 12 weeks.

Also known as: LD
late dinner+Diet

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NovinDiet Clinic

Tehran, Iran

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2017

First Posted

April 26, 2017

Study Start

June 1, 2017

Primary Completion

October 5, 2017

Study Completion

November 18, 2017

Last Updated

October 28, 2019

Record last verified: 2019-10

Locations