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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Internet Diet; Behavioral: Clinic Diet

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • NovinDiet Clinic
  • Tehrān, Iran, Islamic Republic of
    • NovinDiet Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: CD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	kg	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	cm	1year
fasting blood glucoses	mmol/l	1year
fasting insulin level	mU/l	1year
HbA1c	Score	1year
HOMA-IR	percentage (%)	1year
lipid profiles	mmol/l	1year
liver function tests	U/l	1year

Collaborators and Investigators

• Sponsor: Novindiet Clinic
• Collaborators: Tehran University of Medical Sciences; University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): September 29, 2018
• Study Completion (Actual): September 18, 2019

Study Registration Dates

• First Submitted: May 27, 2017
• First Submitted That Met QC Criteria: May 27, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Diet; weight loss; internet-based diet; online dietary coach; clinic visit approach
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: N-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No