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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Nutritional guidance intervention; Behavioral: Nutritional guidance intervention

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah-Tikva, Israel, 49202
    • Schneider Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: girls with obesity attending a dietary intervention; Participants in this group will attend 12 meetings of dietary interventions that will be guided by a dietician.	Behavioral: Nutritional guidance intervention; participants in this group will attend 12 meeting of nutritional guidance; Behavioral: Nutritional guidance intervention; Participants in this group will only receive nutrition guidance once during the study
Active Comparator: girls with obesity; participants in this group will only receive nutrition guidance once during the study	Behavioral: Nutritional guidance intervention; participants in this group will attend 12 meeting of nutritional guidance; Behavioral: Nutritional guidance intervention; Participants in this group will only receive nutrition guidance once during the study
Active Comparator: girls with normal weight; participants in this group will only receive nutrition guidance once during the study	Behavioral: Nutritional guidance intervention; participants in this group will attend 12 meeting of nutritional guidance; Behavioral: Nutritional guidance intervention; Participants in this group will only receive nutrition guidance once during the study

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Joseph MD Meirovitch, Prof., Schneider Children Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): February 20, 2022

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 19, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: rmc027816ctil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No