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

  • Iran, Islamic Republic of
      • 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
Behavioral: online visit group
subjects has online visit with dietitian every 2 weeks+diet
Other Names:
  • OV
Experimental: clinic visit group
clinic visit group ,subject has every 2 weeks in person visit at clinic
Behavioral: Clinic visit group
Clinic visit group ,subjects has every 2 weeks in person visit at clinic+diet
Other Names:
  • CV
Experimental: self-directed group
self-directed group ,subjects receive nutritional information via web and their energy needs for weight loss
Behavioral: self-directed group
self-directed group receives nutritional information via web and their energy needs for weight loss
Other Names:
  • SD

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

Novindiet Clinic

Collaborators

Tehran University of Medical Sciences
University of Nottingham

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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