Back to resultsEffects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Internet Diet
Clinic Diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring weight loss, internet-based diet, online dietary coach, clinic visit approach, Diet
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 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.
Sites / Locations
- NovinDiet Clinic
- NovinDiet Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Internet Diet
Clinic Diet
Arm Description
Internet Diet group have online dietary coach every 2 weeks
clinic visit based weight loss diet program group who have every 2 weeks visit at clinic.
Outcomes
Primary Outcome Measures
Weight
kg
Secondary Outcome Measures
Waist circumference
cm
fasting blood glucoses
mmol/l
fasting insulin level
mU/l
HbA1c
Score
HOMA-IR
percentage (%)
lipid profiles
mmol/l
liver function tests
U/l
Full Information
NCT ID
NCT03171922
First Posted
May 27, 2017
Last Updated
November 24, 2019
Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03171922
Brief Title
Effects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss
Official Title
Effects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss in Healthy Obese Women in a Weight-loss Program: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
September 29, 2018 (Actual)
Study Completion Date
September 18, 2019 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
weight loss, internet-based diet, online dietary coach, clinic visit approach, Diet
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
Internet Diet
Arm Type
Experimental
Arm Description
Internet Diet group have online dietary coach every 2 weeks
Arm Title
Clinic Diet
Arm Type
Experimental
Arm Description
clinic visit based weight loss diet program group who have every 2 weeks visit at clinic.
Intervention Type
Behavioral
Intervention Name(s)
Internet Diet
Other Intervention Name(s)
ID
Intervention Description
ID group have online dietary coach every 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
Clinic Diet
Other Intervention Name(s)
CD
Intervention Description
CD group have every 2 weeks visit at clinic
Primary Outcome Measure Information:
Title
Weight
Description
kg
Time Frame
1year
Secondary Outcome Measure Information:
Title
Waist circumference
Description
cm
Time Frame
1year
Title
fasting blood glucoses
Description
mmol/l
Time Frame
1year
Title
fasting insulin level
Description
mU/l
Time Frame
1year
Title
HbA1c
Description
Score
Time Frame
1year
Title
HOMA-IR
Description
percentage (%)
Time Frame
1year
Title
lipid profiles
Description
mmol/l
Time Frame
1year
Title
liver function tests
Description
U/l
Time Frame
1year
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 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.
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
Learn more about this trial
Effects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss
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