NCT03171922

Brief Summary

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.

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
14 days until next milestone

Study Start

First participant enrolled

June 14, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
Last Updated

November 26, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

May 27, 2017

Last Update Submit

November 24, 2019

Conditions

ObesityOverweight

Keywords

weight lossinternet-based dietonline dietary coachclinic visit approachDiet

Outcome Measures

Primary Outcomes (1)

  • Weight

    kg

    1year

Secondary Outcomes (7)

  • Waist circumference

    1year

  • fasting blood glucoses

    1year

  • fasting insulin level

    1year

  • HbA1c

    1year

  • HOMA-IR

    1year

  • +2 more secondary outcomes

Study Arms (2)

Internet Diet

EXPERIMENTAL

Internet Diet group have online dietary coach every 2 weeks

Behavioral: Internet Diet

Clinic Diet

EXPERIMENTAL

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

Behavioral: Clinic Diet

Interventions

Internet DietBEHAVIORAL

ID group have online dietary coach every 2 weeks

Also known as: ID
Internet Diet
Clinic DietBEHAVIORAL

CD group have every 2 weeks visit at clinic

Also known as: CD
Clinic Diet

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 a personal computer and the Internet

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 14, 2017

Primary Completion

September 29, 2018

Study Completion

September 18, 2019

Last Updated

November 26, 2019

Record last verified: 2019-01

Locations

IR(2)