South Danish Obesity Initiative (SDOI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- Prevalence of unrecognized obesity-related diseases
研究概览
简要总结
People with BMI >30 kg/m2 will be included in at population-based cohort. Additionally, one control group with BMI 18.5-25 kg/m2 and one control group with BMI 25-30 kg/m2 will be included. All participants with age 18 and 60 years.
To evaluate health status participants will be screened by for undetected obesity-related diseases (hypertension, diabetes, dyslipidemia, sleep apnea, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease, EKG-abnormalities, polycystic ovary syndrome (PCOS), and joint pain and for quality of life at baseline, 1 year, and 5 years. Additionally, anthropometric measurements are collected and a biobank is established for future research studies.
People with obesity related disease will be offered participation in a 12 month personalized lifestyle intervention program aimed at improvement of health and self-perception.
The collected data will be used to detect the prevalence for obesity-related disease to identify predictors for future obesity related disease and to evaluate the effect of a lifestyle intervention on health and quality of life.
详细描述
Obesity is associated with a variety of adverse health problems, and there is currently no effective scalable treatment with a durable effect. Additionally, well-known obesity related health problems are often underdiagnosed.
A Danish cohort of people with BMI >30 kg/m2 is established on University Hospital South West Jutland. Additionally, one control group with BMI 18.5-25 kg/m2 and one control group with BMI 25-30 kg/m2 will be included. Age range is defined as 18 and 60 years.
To evaluate health status all participants are screened by for undetected obesity-related diseases (hypertension, diabetes, dyslipidemia, sleep apnea, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease, EKG-abnormalities, polycystic ovary syndrome (PCOS) and joint pain.
Data will be collected from questionnaires (Impact of Weight related on Quality of Life, Attitude to physical activity questionnaire, Adult Eating Behavior questionnaire, Berlin sleep apnea and Epworths Sleepiness scale, PCOS related questionnaire including Ferriman-Gallwey score, Work Ability Index, and weight history); clinical laboratory variables (HbA1c, glucose, c-peptide, lipid status, thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), hemoglobin, thrombocytes, alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), bilirubin, gamma glutamic transferase, lactate dehydrogenase (LDH), alkaline phosphatase, and creatinine levels); and anthropometric measurements (blood pressure, EKG, liver elastography, spirometry (forced expiratory volume during first second as a fraction of forced vital capacity (FEV1/FVC), hand grip strength, gait speed, and CT scan for estimation of the subcutaneous and visceral fat volume). People with diseases uncovered by the screening program will be referred to specialized departments or general practice for further assessment and treatment.
A biobank (blood, feces, urine) is established for future research studies. Patients with obesity related diseases will be invited to participate in a personalized lifestyle intervention program with dietitians and physiotherapists focusing on health improvement through personal motivation, perceived limitations and body accept. Additionally, participants are invited to a 1 year follow-up. All participants, independent of disease status, will be invited for at new screening 5 years after the initial visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI >30 (Obese cohort), BMI 20-25 (control group I), BMI 25-30 (control group II)
- •Age 18-60 years
排除标准
- 未提供
结局指标
主要结局
Prevalence of unrecognized obesity-related diseases
时间窗: 5 years
Undetected obesity-related diseases (hypertension, diabetes, dyslipidemia, sleep apnea, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease, EKG-abnormalities, and polycystic ovary syndrome (PCOS).
次要结局
- HbA1c(5 years)
- Epworth Sleepiness Scale(5 years)
- Elastography(5 years)
- Gait-speed(5 years)
- Body weight(5 years)
- Berlin sleep apnea questionnaire(5 years)
- EKG(5 years)
- BMI(5 years)
- Adult Eating Behavior Questionnaire(5 years)
- Fat-free mass(5 years)
- Prediabetes(5 years)
- Apnea hypopnoea index (AHI)(5 years)
- Ferriman-Gallwey score self-reported(5 years)
- Hand-grip force(five years)
- Waist circumference(5 years)
- Work-ability Index(5 years)
- SDOI attitude to physical activity questionnaire(5 years)
- Consultation systolic and diastolic blood pressure(5 years)
- 24 hour blood pressure(5 years)
- Low density lipoprotein(5 years)
- FEV1/FVC(5 years)
- Impact of weight on quality of life-lite(5 years)
研究者
Claus Bogh Juhl
Professor, MD, PhD
Esbjerg Hospital - University Hospital of Southern Denmark