Effectiveness of Online Visit Compared With In-person Clinic Visit 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:

NCT03171961

First received: May 27, 2017

Last updated: May 27, 2017

Last verified: May 2017

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.

Obesity
Overweight
Behavioral: online visit group
Behavioral: Clinic visit group
Behavioral: self-directed group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss in Overweight and Obese Women, a Randomized Clinical Trial

Primary Outcome Measures:

  • weight [ Time Frame: 24 Weeks ]

    kg

Secondary Outcome Measures:

  • Waist circumference [ Time Frame: 24 Weeks ]

    cm

  • Fasting blood glucose [ Time Frame: 24 Weeks ]

    mmol/l

  • Fasting insulin level [ Time Frame: 24 Weeks ]

    mU/l

  • HbA1c [ Time Frame: 24 Weeks ]

    score

  • HOMA-IR [ Time Frame: 24 Weeks ]

    Percentage (%)

  • lipid profiles [ Time Frame: 24 Weeks ]

    mmol/l

  • liver function tests [ Time Frame: 24 Weeks ]

    U/l

Estimated Enrollment: 120
Anticipated Study Start Date: June 1, 2017
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Experimental: online visit group

in online visit group , subjects has online visit with dietitian every 2 weeks

Behavioral: online visit group

subjects has online visit with dietitian every 2 weeks+diet

Other Name: OV

Experimental: clinic visit group

clinic visit group ,subject has every 2 weeks in person visit at clinic

Behavioral: Clinic visit group

Clinic visit group ,subjects has every 2 weeks in person visit at clinic+diet

Other Name: CV

Experimental: self-directed group

self-directed group ,subjects receive nutritional information via web and their energy needs for weight loss

Behavioral: self-directed group

self-directed group receives nutritional information via web and their energy needs for weight loss

Other Name: SD

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 the internet via broad- band ADSL or Mobile 4G

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: NCT03171961

NovinDiet Clinic
Tehran, Iran, Islamic Republic of
Contact: Ameneh Madjd, Pharm D    00982122263002    mbxsama@nottingham.ac.uk   
Contact: Hamidreza Farshchi Nasr, 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: NCT03171961     History of Changes
Other Study ID Numbers: ND-207
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
Diet
online visit
clinic visit

Additional relevant MeSH terms:

Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 31, 2017