South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease
SDOI
1 other identifier
observational
2,700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
ExpectedOctober 19, 2023
October 1, 2023
5 years
November 10, 2021
October 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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).
5 years
Secondary Outcomes (57)
Consultation systolic and diastolic blood pressure
Baseline
Consultation systolic and diastolic blood pressure
1 year
Consultation systolic and diastolic blood pressure
5 years
24 hour blood pressure
Baseline
24 hour blood pressure
5 years
- +52 more secondary outcomes
Study Arms (3)
OBESE (BMI>30)
BMI above 30 kg/m2 and being 18 to 60 years of age. Since the initiative is open for the general obese population, the investigators did not define the size of the cohort, but expect around 500 referrals per year.
CONTROL Normal weight (BMI 20-25)
100 persons with normal weight (BMI 20 - 25 kg/m2) 18 to 60 years of age
CONTROL Overweight (BMI 25-30)
100 persons with overweight (BMI 25 - 30 kg/m2) 18 to 60 years of age
Interventions
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)
Eligibility Criteria
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.
You may qualify if:
- BMI \>30 (Obese cohort), BMI 20-25 (control group I), BMI 25-30 (control group II)
- Age 18-60 years
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Claus Bogh Juhllead
- Steno Diabetes Center Odensecollaborator
- Odense University Hospitalcollaborator
Study Sites (1)
Hospital of South West Jutland, University hospital of Southern Denmark
Esbjerg, 6700, Denmark
Related Publications (1)
Juhl CB, Bladbjerg EM, Gram B, Knudsen T, Lauridsen MM, Nygaard NB, Drojdahl Ryg N, Skadhauge L, Munster AB. Prevalence of Obesity-Related Disease in a Danish Population - The Results of an Algorithm-Based Screening Program. Diabetes Metab Syndr Obes. 2024 Jun 19;17:2505-2517. doi: 10.2147/DMSO.S456028. eCollection 2024.
PMID: 38910914DERIVED
Biospecimen
Blood sample Feces sample Urine sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claus B Juhl, Prof. PhD MD
Hospital South West Jutland, University hospital of Southern Denmark
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
November 10, 2021
First Posted
January 4, 2022
Study Start
September 1, 2020
Primary Completion
September 1, 2025
Study Completion (Estimated)
September 1, 2030
Last Updated
October 19, 2023
Record last verified: 2023-10