Clinical trial NCT05176132: South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease
Official title: South Danish Obesity Initiative (SDOI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: Obesity
Lifestyle intervention
BMI
Cohort
sleep apnea
diabetes
PCOS
NAFLD
Hypertension
Hyperlipidemia
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Odense
name: Odense University Hospital
First posted: 2022-01-04
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with BMI \> 30 refered from 1) Genaral practice, 2) Other hospital Departments at Hosital South West Jutland, or 3) Psychiatric Department.

The uptake area are 5 muncipalities with mixed urban and rural areas.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BMI \>30 (Obese cohort), BMI 20-25 (control group I), BMI 25-30 (control group II)
* Age 18-60 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence of unrecognized obesity-related diseases
timeFrame: Baseline
measure: Prevalence of unrecognized obesity-related diseases
timeFrame: 5 years
Secondary outcomes:
measure: Consultation systolic and diastolic blood pressure
timeFrame: Baseline
measure: Consultation systolic and diastolic blood pressure
timeFrame: 1 year
measure: Consultation systolic and diastolic blood pressure
timeFrame: 5 years
measure: 24 hour blood pressure
timeFrame: Baseline
measure: 24 hour blood pressure
timeFrame: 5 years
measure: HbA1c
timeFrame: Baseline
measure: HbA1c
timeFrame: 1 year
measure: HbA1c
timeFrame: 5 years
measure: Prediabetes
timeFrame: Baseline
measure: Prediabetes
timeFrame: 1 year
measure: Prediabetes
timeFrame: 5 years
measure: Low density lipoprotein
timeFrame: Baseline
measure: Low density lipoprotein
timeFrame: 1 year
measure: Low density lipoprotein
timeFrame: 5 years
measure: Berlin sleep apnea questionnaire
timeFrame: Baseline
measure: Berlin sleep apnea questionnaire
timeFrame: 5 years
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: 5 years
measure: Apnea hypopnoea index (AHI)
timeFrame: Baseline
measure: Apnea hypopnoea index (AHI)
timeFrame: 5 years
measure: Elastography
timeFrame: Baseline
measure: Elastography
timeFrame: 5 years
measure: FEV1/FVC
timeFrame: Baseline
measure: FEV1/FVC
timeFrame: 5 years
measure: EKG
timeFrame: Baseline
measure: EKG
timeFrame: 5 years
measure: Ferriman-Gallwey score self-reported
timeFrame: Baseline
measure: Ferriman-Gallwey score self-reported
timeFrame: 5 years
measure: Hand-grip force
timeFrame: Baseline
measure: Hand-grip force
timeFrame: 1 year
measure: Hand-grip force
timeFrame: five years
measure: Fat-free mass
timeFrame: Baseline
measure: Fat-free mass
timeFrame: 1 year
measure: Fat-free mass
timeFrame: 5 years
measure: Gait-speed
timeFrame: Baseline
measure: Gait-speed
timeFrame: 1 year
measure: Gait-speed
timeFrame: 5 years
measure: Body weight
timeFrame: Baseline
measure: Body weight
timeFrame: 1 year
measure: Body weight
timeFrame: 5 years
measure: BMI
timeFrame: Baseline
measure: BMI
timeFrame: 1 year
measure: BMI
timeFrame: 5 years
measure: Waist circumference
timeFrame: Baseline
measure: Waist circumference
timeFrame: 1 year
measure: Waist circumference
timeFrame: 5 years
measure: Work-ability Index
timeFrame: Baseline
measure: Work-ability Index
timeFrame: 5 years
measure: Impact of weight on quality of life-lite
timeFrame: Baseline
measure: Impact of weight on quality of life-lite
timeFrame: 1 year
measure: Impact of weight on quality of life-lite
timeFrame: 5 years
measure: Adult Eating Behavior Questionnaire
timeFrame: Baseline
measure: Adult Eating Behavior Questionnaire
timeFrame: 1 year
measure: Adult Eating Behavior Questionnaire
timeFrame: 5 years
measure: SDOI attitude to physical activity questionnaire
timeFrame: baseline
measure: SDOI attitude to physical activity questionnaire
timeFrame: 1 year
measure: SDOI attitude to physical activity questionnaire
timeFrame: 5 years
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of South West Jutland, University hospital of Southern Denmark
Study officials:
affiliation: Hospital South West Jutland, University hospital of Southern Denmark
name: Claus B Juhl, Prof. PhD MD
role: PRINCIPAL_INVESTIGATOR
References: