South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease
ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorClaus Bogh Juhl
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
BMI >30 (Obese cohort), BMI 20-25 (control group I), BMI 25-30 (control group II)
Age 18-60 years
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Life style intervention (dietician+ physiotherapist)
Other interventionObese 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.
Self management
Other interventionPatients with no obesity related diseases will not be offered lifestyle intervention, but encouraged to physical activity (self management)
No intervention
Other interventionControl groups (BMI 20-25 and BMI 25-30)
Treatment groups
2,700 Participants
are divided into 3 treatment groupsGroup A: OBESE (BMI>30)2 interventions
Group B: CONTROL Normal weight (BMI 20-25)1 intervention
Group C: CONTROL Overweight (BMI 25-30)1 intervention
Trial outcomes
Primary outcomes
1
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
Baseline2
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 yearsSecondary outcomes
1
Consultation systolic and diastolic blood pressure
Standard cut-of values
Time frame
Baseline2
Consultation systolic and diastolic blood pressure
Standard cut-of values
Time frame
1 year3
Consultation systolic and diastolic blood pressure
Standard cut-of values
Time frame
5 years4
24 hour blood pressure
Measures mean blood pressure, day and night
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Claus Bogh Juhl
Lead sponsor
Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor institution
Steno Diabetes Center Odense
Collaborator
Odense University Hospital
Collaborator
Source ClinicalTrials.gov