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

NCT ID: NCT02398253

Last Updated: 2019-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CBT + Hypo-energetic Diet

Group Type EXPERIMENTAL

CBT + Hypo-energetic Diet

Intervention Type BEHAVIORAL

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.

Hypo-energetic Diet only

Group Type EXPERIMENTAL

Hypo-energetic Diet only

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role collaborator

Novindiet Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid R Farshchi, MD, PhD

Role: STUDY_CHAIR

NovinDiet Clinic, School of Life Sciences, The University of Nottingham

Ameneh Madjd, Dr.

Role: PRINCIPAL_INVESTIGATOR

NovinDiet Clinic, School of Life Sciences, The University of Nottingham

Ian A Macdonald, Prof.

Role: PRINCIPAL_INVESTIGATOR

School of Life Sciences, The University of Nottingham

Moira A Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Life Sciences, The University of Nottingham

Reza Malekzadeh, Prof.

Role: PRINCIPAL_INVESTIGATOR

Digestive Disease Research Institute, Tehran University of Medical Sciences

Alireza Delavari, MD

Role: PRINCIPAL_INVESTIGATOR

Digestive Disease Research Institute, Tehran University of Medical Sciences

Locations

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NovinDiet Clinic

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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ND-105

Identifier Type: -

Identifier Source: org_study_id

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