- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03171961
Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss
March 17, 2021 updated by: Novindiet Clinic
Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss in Overweight and Obese Women, a Randomized Clinical Trial
Online visit and online counseling via telemedicine technology is a new service for obese people who wish to lose weight but because of their active lifestyle and time limitation cannot come to clinic.
The purpose of this study was to examine the efficacy this technology-based intervention on weight loss in obese and overweight female adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- NovinDiet Clinic
-
Tehrān, Iran, Islamic Republic of
- NovinDiet Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 the internet via broad- band ADSL or Mobile 4G
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: online visit group
in online visit group , subjects has online visit with dietitian every 2 weeks
|
subjects has online visit with dietitian every 2 weeks+diet
Other Names:
|
Experimental: clinic visit group
clinic visit group ,subject has every 2 weeks in person visit at clinic
|
Clinic visit group ,subjects has every 2 weeks in person visit at clinic+diet
Other Names:
|
Experimental: self-directed group
self-directed group ,subjects receive nutritional information via web and their energy needs for weight loss
|
self-directed group receives nutritional information via web and their energy needs for weight loss
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight
Time Frame: 24 Weeks
|
kg
|
24 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lipid profiles
Time Frame: 24 Weeks
|
mmol/l
|
24 Weeks
|
Waist circumference
Time Frame: 24 Weeks
|
cm
|
24 Weeks
|
Fasting blood glucose
Time Frame: 24 Weeks
|
mmol/l
|
24 Weeks
|
Fasting insulin level
Time Frame: 24 Weeks
|
mU/l
|
24 Weeks
|
HbA1c
Time Frame: 24 Weeks
|
score
|
24 Weeks
|
HOMA-IR
Time Frame: 24 Weeks
|
Percentage (%)
|
24 Weeks
|
liver function tests
Time Frame: 24 Weeks
|
U/l
|
24 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2017
Primary Completion (Actual)
February 10, 2018
Study Completion (Actual)
March 11, 2020
Study Registration Dates
First Submitted
May 27, 2017
First Submitted That Met QC Criteria
May 27, 2017
First Posted (Actual)
May 31, 2017
Study Record Updates
Last Update Posted (Actual)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ND-207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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