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

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

Sponsors

Lead Sponsor: Rabin Medical Center

Source Rabin Medical Center
Brief 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.

Overall Status Recruiting
Start Date June 1, 2017
Completion Date December 1, 2020
Primary Completion Date December 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Psychological questionnaires change from baseline Psychological questionnaires at 3 months and at 1 year
Nutritional questionnaires change from baseline Nutritional questionnaires at 3 months and at 1 year
Secondary Outcome
Measure Time Frame
height change from baseline height at 3 months and at 1 year
weight change from baseline weight at 3 months and at 1 year
fat mass change from baseline fat mass at 3 months and at 1 year
circumference of hips change from baseline circumference of hips at 3 months and at 1 year
Enrollment 90
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Nutritional guidance intervention

Description: participants in this group will attend 12 meeting of nutritional guidance

Arm Group Label: girls with obesity attending a dietary intervention

Intervention Type: Behavioral

Intervention Name: Nutritional guidance intervention

Description: Participants in this group will only receive nutrition guidance once during the study

Eligibility

Criteria:

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.

Gender: Female

Minimum Age: 12 Years

Maximum Age: 17 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Joseph MD Meirovitch, Prof. Principal Investigator Schneider children Medical center
Overall Contact

Last Name: Joseph MD Meirovitch, Prof.

Phone: 972-39253619

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Schneider Children's Medical Center Alona Hamou, Msc 972-3-9253778 [email protected] Joseph Meirovitch, MD Principal Investigator
Location Countries

Israel

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: girls with obesity attending a dietary intervention

Type: Experimental

Description: Participants in this group will attend 12 meetings of dietary interventions that will be guided by a dietician.

Label: girls with obesity

Type: Active Comparator

Description: participants in this group will only receive nutrition guidance once during the study

Label: girls with normal weight

Type: Active Comparator

Description: participants in this group will only receive nutrition guidance once during the study

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov