ObesityNCT03171961
Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss
A study testing online visit group, Clinic visit group and self-directed group in people with Obesity and Overweight, run by Novindiet Clinic at 2 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- online visit group, Clinic visit group and self-directed group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesIran
- Study dates
- 20 Jun 2017to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity, Overweight
- Being tested
- online visit group, Clinic visit group, self-directed group
- Keywords
- weight loss, Diet, online visit, clinic visit
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online visit groupBehavioural
Also called OV
subjects has online visit with dietitian every 2 weeks+diet
Clinic visit groupBehavioural
Also called CV
Clinic visit group ,subjects has every 2 weeks in person visit at clinic+diet
self-directed groupBehavioural
Also called SD
self-directed group receives nutritional information via web and their energy needs for weight loss
| Study group | Role | What they receive |
|---|---|---|
| online visit group | Experimental | in online visit group , subjects has online visit with dietitian every 2 weeks Receives: Behavioral: online visit group |
| clinic visit group | Experimental | clinic visit group ,subject has every 2 weeks in person visit at clinic Receives: Behavioral: Clinic visit group |
| self-directed group | Experimental | self-directed group ,subjects receive nutritional information via web and their energy needs for weight loss Receives: Behavioral: self-directed group |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
kg
Measured: 24 Weeks
Secondary outcomes (7)
Waist circumference
cm
Measured: 24 Weeks
Fasting blood glucose
mmol/l
Measured: 24 Weeks
Fasting insulin level
mU/l
Measured: 24 Weeks
HbA1c
score
Measured: 24 Weeks
HOMA-IR
Percentage (%)
Measured: 24 Weeks
lipid profiles
mmol/l
Measured: 24 Weeks
liver function tests
U/l
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start20 Jun 2017
- Primary completion10 Feb 2018
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novindiet Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171961
- Sponsor's protocol ID
- ND-207
- Status last verified
- Oct 2019
- First submitted
- 27 May 2017
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss in Overweight and Obese Women, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03171961
- Acronym / sponsor ID
- ND-207
- Conditions
- Obesity, Overweight
- Keywords
- weight loss, Diet, online visit, clinic visit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Novindiet ClinicUniversity, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| online visit group | Experimental | Behavioral: online visit groupin online visit group , subjects has online visit with dietitian every 2 weeks |
| clinic visit group | Experimental | Behavioral: Clinic visit groupclinic visit group ,subject has every 2 weeks in person visit at clinic |
| self-directed group | Experimental | Behavioral: self-directed groupself-directed group ,subjects receive nutritional information via web and their energy needs for weight loss |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online visit groupAlso: OVsubjects has online visit with dietitian every 2 weeks+diet | Behavioural | online visit group |
| Clinic visit groupAlso: CVClinic visit group ,subjects has every 2 weeks in person visit at clinic+diet | Behavioural | clinic visit group |
| self-directed groupAlso: SDself-directed group receives nutritional information via web and their energy needs for weight loss | Behavioural | self-directed group |
Primary outcome
weight
Time frame: 24 Weeks
kg
7 secondary outcomes
Waist circumference
Time frame: 24 Weeks
Fasting blood glucose
Time frame: 24 Weeks
Fasting insulin level
Time frame: 24 Weeks
HbA1c
Time frame: 24 Weeks
HOMA-IR
Time frame: 24 Weeks
lipid profiles
Time frame: 24 Weeks
liver function tests
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online visit group, Clinic visit group and self-directed group in people with Obesity and Overweight, run by Novindiet Clinic at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.