ObesityNCT03171922
Effects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss
A study testing Internet Diet and Clinic Diet in people with Obesity and Overweight, run by Novindiet Clinic at 2 sites in Iran.
Trial 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. 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?
- Internet Diet and Clinic Diet
- 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
- 14 Jun 2017to 18 Sep 2019
- 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 a personal computer and the Internet
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: 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
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.
- Conditions
- Obesity, Overweight
- Being tested
- Internet Diet, Clinic Diet
- Keywords
- weight loss, internet-based diet, online dietary coach, clinic visit approach, Diet
- 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.
Internet DietBehavioural
Also called ID
ID group have online dietary coach every 2 weeks
Clinic DietBehavioural
Also called CD
CD group have every 2 weeks visit at clinic
| Study group | Role | What they receive |
|---|---|---|
| Internet Diet | Experimental | Internet Diet group have online dietary coach every 2 weeks Receives: Behavioral: Internet Diet |
| Clinic Diet | Experimental | clinic visit based weight loss diet program group who have every 2 weeks visit at clinic. Receives: Behavioral: Clinic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
kg
Measured: 1year
Secondary outcomes (7)
Waist circumference
cm
Measured: 1year
fasting blood glucoses
mmol/l
Measured: 1year
fasting insulin level
mU/l
Measured: 1year
HbA1c
Score
Measured: 1year
HOMA-IR
percentage (%)
Measured: 1year
lipid profiles
mmol/l
Measured: 1year
liver function tests
U/l
Measured: 1year
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 start14 Jun 2017
- Primary completion29 Sep 2018
- Study completion18 Sep 2019
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
- NCT03171922
- Sponsor's protocol ID
- N-206
- Status last verified
- Jan 2019
- First submitted
- 27 May 2017
- Last updated
- 26 Nov 2019
- 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 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03171922
- Acronym / sponsor ID
- N-206
- Conditions
- Obesity, Overweight
- Keywords
- weight loss, internet-based diet, online dietary coach, clinic visit approach, Diet
- 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
- 14 Jun 2017 (actual)
- Primary completion
- 29 Sep 2018 (actual)
- Study completion
- 18 Sep 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet Diet | Experimental | Behavioral: Internet DietInternet Diet group have online dietary coach every 2 weeks |
| Clinic Diet | Experimental | Behavioral: Clinic Dietclinic visit based weight loss diet program group who have every 2 weeks visit at clinic. |
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 |
|---|---|---|
| Internet DietAlso: IDID group have online dietary coach every 2 weeks | Behavioural | Internet Diet |
| Clinic DietAlso: CDCD group have every 2 weeks visit at clinic | Behavioural | Clinic Diet |
Primary outcome
Weight
Time frame: 1year
kg
7 secondary outcomes
Waist circumference
Time frame: 1year
fasting blood glucoses
Time frame: 1year
fasting insulin level
Time frame: 1year
HbA1c
Time frame: 1year
HOMA-IR
Time frame: 1year
lipid profiles
Time frame: 1year
liver function tests
Time frame: 1year
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 26 Nov 2019.
- 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 Internet Diet and Clinic Diet 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 26 Nov 2019. 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: 1year). 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 26 Nov 2019.