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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03171922
Other study ID # N-206
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 14, 2017
Est. completion date September 18, 2019

Study information

Verified date January 2019
Source Novindiet Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the efficacy of an internet based diet plus a regular dedicated dietary coach (ID group) versus clinic visit based weight loss program (CD group) on weight loss in obese and overweight female adults.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 18, 2019
Est. primary completion date September 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Must be female

- 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.

- Have access to a personal computer and the Internet

Exclusion Criteria:

- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.

- Taking medications 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Internet Diet
ID group have online dietary coach every 2 weeks
Clinic Diet
CD group have every 2 weeks visit at clinic

Locations

Country Name City State
Iran, Islamic Republic of NovinDiet Clinic Tehran
Iran, Islamic Republic of NovinDiet Clinic Tehran

Sponsors (3)

Lead Sponsor Collaborator
Novindiet Clinic Tehran University of Medical Sciences, University of Nottingham

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight kg 1year
Secondary Waist circumference cm 1year
Secondary fasting blood glucoses mmol/l 1year
Secondary fasting insulin level mU/l 1year
Secondary HbA1c Score 1year
Secondary HOMA-IR percentage (%) 1year
Secondary lipid profiles mmol/l 1year
Secondary liver function tests U/l 1year
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