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Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
online visit group
Clinic visit group
self-directed group
Sponsored by
Novindiet Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss, Diet, online visit, clinic visit

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • NovinDiet Clinic
  • NovinDiet Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

online visit group

clinic visit group

self-directed group

Arm Description

in online visit group , subjects has online visit with dietitian every 2 weeks

clinic visit group ,subject has every 2 weeks in person visit at clinic

self-directed group ,subjects receive nutritional information via web and their energy needs for weight loss

Outcomes

Primary Outcome Measures

weight
kg

Secondary Outcome Measures

Waist circumference
cm
Fasting blood glucose
mmol/l
Fasting insulin level
mU/l
HbA1c
score
HOMA-IR
Percentage (%)
lipid profiles
mmol/l
liver function tests
U/l

Full Information

First Posted
May 27, 2017
Last Updated
March 17, 2021
Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03171961
Brief Title
Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss
Official Title
Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss in Overweight and Obese Women, a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
February 10, 2018 (Actual)
Study Completion Date
March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
weight loss, Diet, online visit, clinic visit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
online visit group
Arm Type
Experimental
Arm Description
in online visit group , subjects has online visit with dietitian every 2 weeks
Arm Title
clinic visit group
Arm Type
Experimental
Arm Description
clinic visit group ,subject has every 2 weeks in person visit at clinic
Arm Title
self-directed group
Arm Type
Experimental
Arm Description
self-directed group ,subjects receive nutritional information via web and their energy needs for weight loss
Intervention Type
Behavioral
Intervention Name(s)
online visit group
Other Intervention Name(s)
OV
Intervention Description
subjects has online visit with dietitian every 2 weeks+diet
Intervention Type
Behavioral
Intervention Name(s)
Clinic visit group
Other Intervention Name(s)
CV
Intervention Description
Clinic visit group ,subjects has every 2 weeks in person visit at clinic+diet
Intervention Type
Behavioral
Intervention Name(s)
self-directed group
Other Intervention Name(s)
SD
Intervention Description
self-directed group receives nutritional information via web and their energy needs for weight loss
Primary Outcome Measure Information:
Title
weight
Description
kg
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Waist circumference
Description
cm
Time Frame
24 Weeks
Title
Fasting blood glucose
Description
mmol/l
Time Frame
24 Weeks
Title
Fasting insulin level
Description
mU/l
Time Frame
24 Weeks
Title
HbA1c
Description
score
Time Frame
24 Weeks
Title
HOMA-IR
Description
Percentage (%)
Time Frame
24 Weeks
Title
lipid profiles
Description
mmol/l
Time Frame
24 Weeks
Title
liver function tests
Description
U/l
Time Frame
24 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
NovinDiet Clinic
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
NovinDiet Clinic
City
Tehrān
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss

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