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Completed

NCT Number: NCT02398253

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NovinDiet Clinic

Tehran, 1913635136, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT + Hypo-energetic Diet

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

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.

Primary outcomes

  1. Weight loss

    Time frame: 24 Weeks

Secondary outcomes

  1. Fasting plasma glucose level

    Time frame: 24 weeks

  2. lipid profiles

    Time frame: 48 weeks

  3. Insulin resistance(HOMA)

    Time frame: 24 weeks

  4. Waist circumference

    Time frame: 24 Weeks

  5. Body mass index reduction

    Time frame: 24 Weeks

Sponsors and collaborators

Lead sponsor

Novindiet Clinic

Other

Collaborators

  • Tehran University of Medical Sciences
  • University of Nottingham

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2015
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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