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

NCT03087994 | Completed

• 1 other identifier: rmc027816ctil
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (3)

girls with obesity attending a dietary intervention

EXPERIMENTAL

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

Behavioral: Nutritional guidance intervention

girls with obesity

ACTIVE COMPARATOR

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

Behavioral: Nutritional guidance intervention

girls with normal weight

ACTIVE COMPARATOR

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

Behavioral: Nutritional guidance intervention

Interventions

Nutritional guidance intervention BEHAVIORAL

participants in this group will attend 12 meeting of nutritional guidance

girls with obesity attending a dietary intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph MD Meirovitch, Prof.

  Schneider children Medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 23, 2017
• Study Start: June 1, 2017
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)