Effects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss


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Verified May 2017 by Novindiet Clinic

Sponsor:

Collaborators:

University of Nottingham

Tehran University of Medical Sciences

Information provided by (Responsible Party):

Novindiet Clinic

ClinicalTrials.gov Identifier:

NCT03171922

First received: May 27, 2017

Last updated: May 27, 2017

Last verified: May 2017

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.

Obesity
Overweight
Behavioral: Internet Diet
Behavioral: Clinic Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
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

Primary Outcome Measures:

  • Weight [ Time Frame: 12 Weeks ]

    kg

Secondary Outcome Measures:

  • Waist circumference [ Time Frame: 12 Weeks ]

    cm

  • fasting blood glucoses [ Time Frame: 12 Weeks ]

    mmol/l

  • fasting insulin level [ Time Frame: 12 Weeks ]

    mU/l

  • HbA1c [ Time Frame: 12 Weeks ]

    Score

  • HOMA-IR [ Time Frame: 12 Weeks ]

    percentage (%)

  • lipid profiles [ Time Frame: 12 Weeks ]

    mmol/l

  • liver function tests [ Time Frame: 12 Weeks ]

    U/l

Estimated Enrollment: 120
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Experimental: Internet Diet

Internet Diet group have online dietary coach every 2 weeks

Behavioral: Internet Diet

ID group have online dietary coach every 2 weeks

Other Name: ID

Experimental: Clinic Diet

clinic visit based weight loss diet program group who have every 2 weeks visit at clinic.

Behavioral: Clinic Diet

CD group have every 2 weeks visit at clinic

Other Name: CD

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03171922

NovinDiet Clinic
Tehran, Iran, Islamic Republic of
Contact: Ameneh Madjd, Pharm D    00982122263002    mbxsama@nottingham.ac.uk   
Contact: Hamidreza Farshchi, MD, PhD    00982122263002    hrfarshchi@gmail.com   
NovinDiet Clinic
Tehrān, Iran, Islamic Republic of
Contact: Ameneh Madjd, Pharm. D    00982122263002    mbxsama@nottingham.ac.uk   
Contact: Hamidreza , Farshchi, MD, PhD    00982122263002    hrfarshchi@gmail.com   

Novindiet Clinic

University of Nottingham

Tehran University of Medical Sciences

Responsible Party: Novindiet Clinic
ClinicalTrials.gov Identifier: NCT03171922     History of Changes
Other Study ID Numbers: N-206
Study First Received: May 27, 2017
Last Updated: May 27, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novindiet Clinic:

weight loss
internet-based diet
online dietary coach
clinic visit approach
Diet

Additional relevant MeSH terms:

Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 31, 2017