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.
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. The data collected for the cohort will be used to estimate the prevalence and development of new obesity-related diseases, and to identify predictors for obesity-related diseases. Finally, the effect of the lifestyle intervention-program will be evaluated.
Study Type
OBSERVATIONAL
Enrollment
2,700
Obese patients with obesity related diseases will be invited to participate in a personalized lifestyle intervention program with dieticians and physiotherapists focusing on health improvement through personal motivation and perceived limitations and body accept.
Patients with no obesity related diseases will not be offered lifestyle intervention, but encouraged to physical activity (self management)
Control groups (BMI 20-25 and BMI 25-30)
Hospital of South West Jutland, University hospital of Southern Denmark
Esbjerg, Denmark
RECRUITINGPrevalence of unrecognized obesity-related diseases
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).
Time frame: Baseline
Prevalence of unrecognized obesity-related diseases
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).
Time frame: 5 years
Consultation systolic and diastolic blood pressure
Standard cut-of values
Time frame: Baseline
Consultation systolic and diastolic blood pressure
Standard cut-of values
Time frame: 1 year
Consultation systolic and diastolic blood pressure
Standard cut-of values
Time frame: 5 years
24 hour blood pressure
Measures mean blood pressure, day and night
Time frame: Baseline
24 hour blood pressure
Measures mean blood pressure, day and night
Time frame: 5 years
HbA1c
HbA1c equal to or higher than 48 mmol/mol indicates diabetes
Time frame: Baseline
HbA1c
HbA1c equal to or higher than 48 mmol/mol indicates diabetes
Time frame: 1 year
HbA1c
HbA1c equal to or higher than 48 mmol/mol indicates diabetes
Time frame: 5 years
Prediabetes
Hba1c 43-47 indicates prediabetes
Time frame: Baseline
Prediabetes
Hba1c 43-47 indicates prediabetes
Time frame: 1 year
Prediabetes
Hba1c 43-47 indicates prediabetes
Time frame: 5 years
Low density lipoprotein
Dyslipidemia is defined as low density lipoprotein (LDL) \> 3 mmol/l or high density lipoprotein (HDL) cholesterol \< 1 mmol/l.
Time frame: Baseline
Low density lipoprotein
Dyslipidemia is defined as low density lipoprotein (LDL) \> 3 mmol/l or high density lipoprotein (HDL) cholesterol \< 1 mmol/l.
Time frame: 1 year
Low density lipoprotein
Dyslipidemia is defined as low density lipoprotein (LDL) \> 3 mmol/l or high density lipoprotein (HDL) cholesterol \< 1 mmol/l.
Time frame: 5 years
Berlin sleep apnea questionnaire
Berlin sleep apnea questionnaire: The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.
Time frame: Baseline
Berlin sleep apnea questionnaire
Berlin sleep apnea questionnaire: The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.
Time frame: 5 years
Epworth Sleepiness Scale
Epworth Sleepiness Scale: Score 0-24. 0-5 Lower Normal Daytime Sleepiness, 6-10 Higher Normal Daytime Sleepiness, 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness, 16-24 Severe Excessive Daytime Sleepiness
Time frame: Baseline
Epworth Sleepiness Scale
Epworth Sleepiness Scale: Score 0-24. 0-5 Lower Normal Daytime Sleepiness, 6-10 Higher Normal Daytime Sleepiness, 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness, 16-24 Severe Excessive Daytime Sleepiness
Time frame: 5 years
Apnea hypopnoea index (AHI)
Quantifies sleep apnea cardiorespiratory monitoring: AHI \< 5 per hour=normal or minimal, AHI ≥ 5, but \< 15 per hour: mild, AHI ≥ 15, but \< 30 per hour moderate and AHI ≥ 30 per hour: severe
Time frame: Baseline
Apnea hypopnoea index (AHI)
Quantifies sleep apnea cardiorespiratory monitoring: AHI \< 5 per hour=normal or minimal, AHI ≥ 5, but \< 15 per hour: mild, AHI ≥ 15, but \< 30 per hour moderate and AHI ≥ 30 per hour: severe
Time frame: 5 years
Elastography
Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better
Time frame: Baseline
Elastography
Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better
Time frame: 5 years
FEV1/FVC
Indication of Chronic obstructive pulmonary disease as measured by spirometry
Time frame: Baseline
FEV1/FVC
Indication of Chronic obstructive pulmonary disease as measured by spirometry
Time frame: 5 years
EKG
Under resting conditions, standard 12 lead electrocardiography
Time frame: Baseline
EKG
Under resting conditions, standard 12 lead electrocardiography
Time frame: 5 years
Ferriman-Gallwey score self-reported
Measures hirsutism and indicates risk of Polycystic ovary syndrome (PCOS): Whole body equal or less than 10: normal, over 10: increased, Face: more than 2 is considered high and indicates hirsutism
Time frame: Baseline
Ferriman-Gallwey score self-reported
Measures hirsutism and indicates risk of Polycystic ovary syndrome (PCOS): Whole body equal or less than 10: normal, over 10: increased, Face: more than 2 is considered high and indicates hirsutism
Time frame: 5 years
Hand-grip force
Handgrip force: Higher is better, no defined cut-off value
Time frame: Baseline
Hand-grip force
Handgrip force: Higher is better, no defined cut-off value
Time frame: 1 year
Hand-grip force
Handgrip force: Higher is better, no defined cut-off value
Time frame: five years
Fat-free mass
Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value
Time frame: Baseline
Fat-free mass
Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value
Time frame: 1 year
Fat-free mass
Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value
Time frame: 5 years
Gait-speed
Gait Speed in 6 meters: High more than 1.1 m/s, Median 0.7-1.1 m/s, Low \<0.7 m/s
Time frame: Baseline
Gait-speed
Gait Speed in 6 meters: High more than 1.1 m/s, Median 0.7-1.1 m/s, Low \<0.7 m/s
Time frame: 1 year
Gait-speed
Gait Speed in 6 meters: High more than 1.1 m/s, Median 0.7-1.1 m/s, Low \<0.7 m/s
Time frame: 5 years
Body weight
Participants are weighed in light clothes with no shoes or pocket items, lower is better
Time frame: Baseline
Body weight
Participants are weighed in light clothes with no shoes or pocket items, lower is better
Time frame: 1 year
Body weight
Participants are weighed in light clothes with no shoes or pocket items, lower is better
Time frame: 5 years
BMI
Body weight / m2, lower is better
Time frame: Baseline
BMI
Body weight / m2, lower is better
Time frame: 1 year
BMI
Body weight / m2, lower is better
Time frame: 5 years
Waist circumference
Lower is better
Time frame: Baseline
Waist circumference
Lower is better
Time frame: 1 year
Waist circumference
Lower is better
Time frame: 5 years
Work-ability Index
Measures the ability of a person to work, higher values are better, no cut-of value
Time frame: Baseline
Work-ability Index
Measures the ability of a person to work, higher values are better, no cut-of value
Time frame: 5 years
Impact of weight on quality of life-lite
Measures weight associated quality of life, higher values are better, no cut-of value
Time frame: Baseline
Impact of weight on quality of life-lite
Measures weight associated quality of life, higher values are better, no cut-of value
Time frame: 1 year
Impact of weight on quality of life-lite
Measures weight associated quality of life, higher values are better, no cut-of value
Time frame: 5 years
Adult Eating Behavior Questionnaire
Measures eating behavior and appetite traits, descriptive
Time frame: Baseline
Adult Eating Behavior Questionnaire
Measures eating behavior and appetite traits, descriptive
Time frame: 1 year
Adult Eating Behavior Questionnaire
Measures eating behavior and appetite traits, descriptive
Time frame: 5 years
SDOI attitude to physical activity questionnaire
Measures a persons attitude to physical activity, higher is better, no cut-of value
Time frame: baseline
SDOI attitude to physical activity questionnaire
Measures a persons attitude to physical activity, higher is better, no cut-of value
Time frame: 1 year
SDOI attitude to physical activity questionnaire
Measures a persons attitude to physical activity, higher is better, no cut-of value
Time frame: 5 years
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