Effects of Cognitive Behavioral Therapy (CBT) on Weight Maintenance After Successful Weight Loss

October 24, 2019 updated by: Novindiet Clinic

Effects of Cognitive Behavioral Therapy After a Successful Weight Loss by a Comprehensive Weight Loss Plan (NovinDiet Plan) on Weight Maintenance in Healthy Obese Female Adults: a Randomized Clinical Trial

The purpose of this study is to assess the effects of CBT after a successful weight loss by a comprehensive weight loss plan on weight maintenance in obese female adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
  • Must be able to have moderate exercise.
  • Must be interested to keep weight loss.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT + Hypo-energetic Diet
Behavioral: CBT + Hypo-energetic Diet
This group will have cognitive behavioral therapy classes + follow the hypo-energetic diet after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.
Experimental: Hypo-energetic Diet only
Behavioral: Hypo-energetic Diet only
This group will receive the hypo-energetic diet only after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 24 Weeks
24 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting plasma glucose level
Time Frame: 24 weeks
24 weeks
lipid profiles
Time Frame: 48 weeks
48 weeks
Insulin resistance(HOMA)
Time Frame: 24 weeks
24 weeks
Waist circumference
Time Frame: 24 Weeks
24 Weeks
Body mass index reduction
Time Frame: 24 Weeks
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novindiet Clinic

Collaborators

Tehran University of Medical Sciences
University of Nottingham

Investigators

  • Study Chair: Hamid R Farshchi, MD, PhD, NovinDiet Clinic, School of Life Sciences, The University of Nottingham
  • Principal Investigator: Ameneh Madjd, Dr., NovinDiet Clinic, School of Life Sciences, The University of Nottingham
  • Principal Investigator: Ian A Macdonald, Prof., School of Life Sciences, The University of Nottingham
  • Principal Investigator: Moira A Taylor, PhD, School of Life Sciences, The University of Nottingham
  • Principal Investigator: Reza Malekzadeh, Prof., Digestive Disease Research Institute, Tehran University of Medical Sciences
  • Principal Investigator: Alireza Delavari, MD, Digestive Disease Research Institute, Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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