The Influence of Obesity on Level of Depression and Cognitive and Executive Functions

Obesity Clinical Trial

Official title:

The Influence of Obesity on Level of Depression and Cognitive and Executive Functions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087994
• Other study ID #: rmc027816ctil
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: February 20, 2022

Study information

• Verified date: February 2022
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study is a randomized, open, comparative research involving an intervention group and two control groups.

The aims of the study are: 1.To compare levels of depression in female adolescents with obesity and a control group of female adolescents with appropriate weight and height. 2. To investigate whether a decrease in weight due to a short range intervention program provided by dietician for female adolescents with obesity will lead to change in the levels of symptoms of depression and cognitive and executive functions in comparison to a control group of adolescent girls with obesity, matched in age that does not receive such an intervention program.

60 Female adolescents with obesity will be recruited to the study and will be randomized to 1 of two groups- 1. intervention group- participants in this group will attend an intervention program consisting of 12 meetings with dietician and will attend two study visits at the clinic- in the beginning of the study and after three months. 2.Control group- Participants in this group will only come to two study visits at the clinic. In the first two visits they will meet with a dietician and will receive nutrition guidance.

Another 30 girls with appropriate weight will be recruited to second control group- this group will come to two study visits at the clinic- in the beginning of the study and after three months. In the first visit participants will receive nutrition guidance by the dietician.

In the study visits the following procedures will be performed for all study groups: Blood tests, completion of psychological and nutritional questionnaires, completion of computerized tests and measurements of height, weight, fat mass and circumference of hips.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 20, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Adolescent girls aged 12-17, who attend the Endocrinology Institute in Schneider Hospital and comply with the research criteria: obesity (BMI above percentile 85) and appropriate weight (BMI between percentiles 5-85).

2. Adolescent level according to Tanner: 4-5.

3. Participants with obesity: BMI above percentile 85 for age group.

4. Participants in control group with appropriate weight: BMI percentile 5-85 for age group.

5. Appropriate height (Percentiles 3-97 according to the CDC curve).

6. Parents' signature on informed consent form.

Exclusion Criteria:

1. Chronic illness or chronic use of medications.

2. Inability to comply with the research conditions.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Nutritional guidance intervention
participants in this group will attend 12 meeting of nutritional guidance
• Nutritional guidance intervention
Participants in this group will only receive nutrition guidance once during the study

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological questionnaires		change from baseline Psychological questionnaires at 3 months and at 1 year
Primary	Nutritional questionnaires		change from baseline Nutritional questionnaires at 3 months and at 1 year
Secondary	height		change from baseline height at 3 months and at 1 year
Secondary	weight		change from baseline weight at 3 months and at 1 year
Secondary	fat mass		change from baseline fat mass at 3 months and at 1 year
Secondary	circumference of hips		change from baseline circumference of hips at 3 months and at 1 year