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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398253
• Other study ID #: ND-105
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2019
• Source: Novindiet Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	NovinDiet Clinic	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Novindiet Clinic	Tehran University of Medical Sciences, University of Nottingham

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		24 Weeks
Secondary	Fasting plasma glucose level		24 weeks
Secondary	lipid profiles		48 weeks
Secondary	Insulin resistance(HOMA)		24 weeks
Secondary	Waist circumference		24 Weeks
Secondary	Body mass index reduction		24 Weeks