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

Primary Purpose

Obesity, Overweight

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

CBT + Hypo-energetic Diet

Hypo-energetic Diet only

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight maintenance, cognitive behavior therapy, successful weight loss

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

NovinDiet Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CBT + Hypo-energetic Diet

Hypo-energetic Diet only

Arm Description

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Fasting plasma glucose level

lipid profiles

Insulin resistance(HOMA)

Waist circumference

Body mass index reduction

Full Information

NCT ID

NCT02398253

First Posted

March 20, 2015

Last Updated

October 24, 2019

Sponsor

Novindiet Clinic

Collaborators

Tehran University of Medical Sciences, University of Nottingham

1. Study Identification

Unique Protocol Identification Number

NCT02398253

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novindiet Clinic

Collaborators

Tehran University of Medical Sciences, University of Nottingham

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

Keywords

weight maintenance, cognitive behavior therapy, successful weight loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT + Hypo-energetic Diet

Arm Type

Experimental

Arm Title

Hypo-energetic Diet only

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

CBT + Hypo-energetic Diet

Intervention Description

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

Intervention Name(s)

Hypo-energetic Diet only

Intervention Description

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.

Primary Outcome Measure Information:

Title

Weight loss

Time Frame

24 Weeks

Secondary Outcome Measure Information:

Title

Fasting plasma glucose level

Time Frame

24 weeks

Title

lipid profiles

Time Frame

48 weeks

Title

Insulin resistance(HOMA)

Time Frame

24 weeks

Title

Waist circumference

Time Frame

24 Weeks

Title

Body mass index reduction

Time Frame

24 Weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: