Obesity Clinical Trial
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
| NCT number | NCT03171922 |
| Other study ID # | N-206 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 14, 2017 |
| Est. completion date | September 18, 2019 |
| Verified date | January 2019 |
| Source | Novindiet Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | September 18, 2019 |
| Est. primary completion date | September 29, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | NovinDiet Clinic | Tehran | |
| Iran, Islamic Republic of | NovinDiet Clinic | Tehran |
| Lead Sponsor | Collaborator |
|---|---|
| Novindiet Clinic | Tehran University of Medical Sciences, University of Nottingham |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Weight | kg | 1year | |
| Secondary | Waist circumference | cm | 1year | |
| Secondary | fasting blood glucoses | mmol/l | 1year | |
| Secondary | fasting insulin level | mU/l | 1year | |
| Secondary | HbA1c | Score | 1year | |
| Secondary | HOMA-IR | percentage (%) | 1year | |
| Secondary | lipid profiles | mmol/l | 1year | |
| Secondary | liver function tests | U/l | 1year |
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