Clinical trial NCT03087994: The Influence of Obesity on Level of Depression and Cognitive and Executive Functions
Official title: The Influence of Obesity on Level of Depression and Cognitive and Executive Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Psychological questionnaires
timeFrame: change from baseline Psychological questionnaires at 3 months and at 1 year
measure: Nutritional questionnaires
timeFrame: change from baseline Nutritional questionnaires at 3 months and at 1 year
Secondary outcomes:
measure: height
timeFrame: change from baseline height at 3 months and at 1 year
measure: weight
timeFrame: change from baseline weight at 3 months and at 1 year
measure: fat mass
timeFrame: change from baseline fat mass at 3 months and at 1 year
measure: circumference of hips
timeFrame: change from baseline circumference of hips at 3 months and at 1 year
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Schneider children Medical center
name: Joseph MD Meirovitch, Prof.
role: PRINCIPAL_INVESTIGATOR
References: