ObesityNCT03087994
The Influence of Obesity on Level of Depression and Cognitive and Executive Functions
A study testing Nutritional guidance intervention in people with Obesity, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutritional guidance intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2017to 20 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Chronic illness or chronic use of medications.
- Inability to comply with the research conditions.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Nutritional guidance intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional guidance interventionBehavioural
participants in this group will attend 12 meeting of nutritional guidance
Nutritional guidance interventionBehavioural
Participants in this group will only receive nutrition guidance once during the study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutritional guidance intervention |
| girls with obesity | Active comparator | participants in this group will only receive nutrition guidance once during the study Receives: Behavioral: Nutritional guidance intervention |
| girls with normal weight | Active comparator | participants in this group will only receive nutrition guidance once during the study Receives: Behavioral: Nutritional guidance intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological questionnaires
Measured: change from baseline Psychological questionnaires at 3 months and at 1 year
Nutritional questionnaires
Measured: change from baseline Nutritional questionnaires at 3 months and at 1 year
Secondary outcomes (4)
height
Measured: change from baseline height at 3 months and at 1 year
weight
Measured: change from baseline weight at 3 months and at 1 year
fat mass
Measured: change from baseline fat mass at 3 months and at 1 year
circumference of hips
Measured: change from baseline circumference of hips at 3 months and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Jun 2017
- Primary completion20 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph MD Meirovitch, Prof., Principal investigator, Schneider children Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087994
- Sponsor's protocol ID
- rmc027816ctil
- Status last verified
- Feb 2022
- First submitted
- 6 Mar 2017
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Obesity on Level of Depression and Cognitive and Executive Functions
- ClinicalTrials.gov ID
- NCT03087994
- Acronym / sponsor ID
- rmc027816ctil
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| girls with obesity attending a dietary intervention | Experimental | Behavioral: Nutritional guidance interventionParticipants in this group will attend 12 meetings of dietary interventions that will be guided by a dietician. |
| girls with obesity | Active comparator | Behavioral: Nutritional guidance interventionparticipants in this group will only receive nutrition guidance once during the study |
| girls with normal weight | Active comparator | Behavioral: Nutritional guidance interventionparticipants in this group will only receive nutrition guidance once during the study |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- Chronic illness or chronic use of medications.
- Inability to comply with the research conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional guidance interventionparticipants in this group will attend 12 meeting of nutritional guidance | Behavioural | girls with obesity attending a dietary intervention |
| Nutritional guidance interventionParticipants in this group will only receive nutrition guidance once during the study | Behavioural | girls with normal weight, girls with obesity |
Primary outcome
Psychological questionnaires
Time frame: change from baseline Psychological questionnaires at 3 months and at 1 year
Nutritional questionnaires
Time frame: change from baseline Nutritional questionnaires at 3 months and at 1 year
4 secondary outcomes
height
Time frame: change from baseline height at 3 months and at 1 year
weight
Time frame: change from baseline weight at 3 months and at 1 year
fat mass
Time frame: change from baseline fat mass at 3 months and at 1 year
circumference of hips
Time frame: change from baseline circumference of hips at 3 months and at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph MD Meirovitch, Prof. principal investigator
Schneider children Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional guidance intervention in people with Obesity, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological questionnaires (time frame: change from baseline Psychological questionnaires at 3 months and at 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.