The Influence of Obesity on Level of Depression and Cognitive and Executive Functions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Nutritional questionnaires
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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-
- •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.
排除标准
- •Chronic illness or chronic use of medications.
- •Inability to comply with the research conditions.
研究组 & 干预措施
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.
干预措施: Nutritional guidance intervention (Behavioral)
girls with obesity
participants in this group will only receive nutrition guidance once during the study
干预措施: Nutritional guidance intervention (Behavioral)
girls with normal weight
participants in this group will only receive nutrition guidance once during the study
干预措施: Nutritional guidance intervention (Behavioral)
结局指标
主要结局
Nutritional questionnaires
时间窗: change from baseline Nutritional questionnaires at 3 months and at 1 year
Psychological questionnaires
时间窗: change from baseline Psychological questionnaires at 3 months and at 1 year
次要结局
- 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)