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Completed

NCT Number: NCT03087994

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.

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Key information

Age range

12 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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).
  • Adolescent level according to Tanner: 4-5.
  • Participants with obesity: BMI above percentile 85 for age group.
  • Participants in control group with appropriate weight: BMI percentile 5-85 for age group.
  • Appropriate height (Percentiles 3-97 according to the CDC curve).
  • Parents' signature on informed consent form.

Exclusion criteria

  • Chronic illness or chronic use of medications.
  • Inability to comply with the research conditions.

Treatment and study plan

Nutritional guidance intervention

Behavioral

participants in this group will attend 12 meeting of nutritional guidance

Primary outcomes

  1. Psychological questionnaires

    Time frame: change from baseline Psychological questionnaires at 3 months and at 1 year

  2. Nutritional questionnaires

    Time frame: change from baseline Nutritional questionnaires at 3 months and at 1 year

Secondary outcomes

  1. height

    Time frame: change from baseline height at 3 months and at 1 year

  2. weight

    Time frame: change from baseline weight at 3 months and at 1 year

  3. fat mass

    Time frame: change from baseline fat mass at 3 months and at 1 year

  4. circumference of hips

    Time frame: change from baseline circumference of hips at 3 months and at 1 year

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2017
Registry last updated
Feb 22, 2022

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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