NCT03171961

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

June 20, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
Last Updated

March 18, 2021

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

May 27, 2017

Last Update Submit

March 17, 2021

Conditions

Keywords

weight lossDietonline visitclinic visit

Outcome Measures

Primary Outcomes (1)

  • weight

    kg

    24 Weeks

Secondary Outcomes (7)

  • Waist circumference

    24 Weeks

  • Fasting blood glucose

    24 Weeks

  • Fasting insulin level

    24 Weeks

  • HbA1c

    24 Weeks

  • HOMA-IR

    24 Weeks

  • +2 more secondary outcomes

Study Arms (3)

online visit group

EXPERIMENTAL

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

Behavioral: online visit group

clinic visit group

EXPERIMENTAL

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

Behavioral: Clinic visit group

self-directed group

EXPERIMENTAL

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

Behavioral: self-directed group

Interventions

subjects has online visit with dietitian every 2 weeks+diet

Also known as: OV
online visit group

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

Also known as: CV
clinic visit group

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

Also known as: SD
self-directed group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NovinDiet Clinic

Tehran, Iran

Location

NovinDiet Clinic

Tehrān, Iran

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2017

First Posted

May 31, 2017

Study Start

June 20, 2017

Primary Completion

February 10, 2018

Study Completion

March 11, 2020

Last Updated

March 18, 2021

Record last verified: 2019-10

Locations