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CompletedNCT03087994Updated Feb 22, 2022

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

An interventional study of Nutritional guidance intervention and Nutritional guidance intervention in Obesity, sponsored by Rabin Medical Center. Completed at 1 site in Israel. Open to female participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-22.

Sponsored by Rabin Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Obesity

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 80 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Chronic illness or chronic use of medications.
  2. Inability to comply with the research conditions.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • 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

  • Active comparator
    girls with obesity

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

    Behavioral: Nutritional guidance intervention

  • Active comparator
    girls with normal weight

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

    Behavioral: Nutritional guidance intervention

Interventions

  • BehavioralNutritional guidance intervention

    participants in this group will attend 12 meeting of nutritional guidance

  • BehavioralNutritional guidance intervention

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

06

What researchers measure

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

07

Study locations

1 site
  • Schneider Children's Medical Center
    Petah-Tikva, 49202, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03087994
Lead sponsor
Rabin Medical Center
Responsible party
Sponsor
First posted
Mar 23, 2017
Start date
Jun 1, 2017
Primary completion
Feb 20, 2022
Completion
Feb 20, 2022
Last update
Feb 22, 2022

Study contacts

Joseph MD Meirovitch, Prof.
principal investigator · Schneider children Medical center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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