South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease (SDOI)

South Danish Obesity Initiative (SDOI)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Life style intervention (dietician+ physiotherapist); Other: Self management; Other: No intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 2700

Contacts and Locations

• Study Contact: Name: Claus B Juhl, Prof. PhD MD; Phone Number: 60867172; Email: claus.bogh.juhl@rsyd.dk
• Study Contact Backup: Name: Nina Drøjdahl Ryg, MSc PhD; Phone Number: 26353163; Email: nina.droejdahl.ryg@rsyd.dk

Study Locations

• Denmark
  • Esbjerg, Denmark, 6700
    • Recruiting
    • Hospital of South West Jutland, University hospital of Southern Denmark
    • Contact: Nina Drøjdahl Ryg, MSc PhD; Phone Number: 26353163; Email: nina.droejdahl.ryg@rsyd.dk
    • Contact: Claus B Juhl, MD PhD; Phone Number: 60867172; Email: claus.bogh.juhl@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Life style intervention (dietician+ physiotherapist); 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.; Other: Self management; Patients with no obesity related diseases will not be offered lifestyle intervention, but encouraged to physical activity (self management)
CONTROL Normal weight (BMI 20-25); 100 persons with normal weight (BMI 20 - 25 kg/m2) 18 to 60 years of age	Other: No intervention; Control groups (BMI 20-25 and BMI 25-30)
CONTROL Overweight (BMI 25-30); 100 persons with overweight (BMI 25 - 30 kg/m2) 18 to 60 years of age	Other: No intervention; Control groups (BMI 20-25 and BMI 25-30)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consultation systolic and diastolic blood pressure	Standard cut-of values	Baseline
Consultation systolic and diastolic blood pressure	Standard cut-of values	1 year
Consultation systolic and diastolic blood pressure	Standard cut-of values	5 years
24 hour blood pressure	Measures mean blood pressure, day and night	Baseline
24 hour blood pressure	Measures mean blood pressure, day and night	5 years
HbA1c	HbA1c equal to or higher than 48 mmol/mol indicates diabetes	Baseline
HbA1c	HbA1c equal to or higher than 48 mmol/mol indicates diabetes	1 year
HbA1c	HbA1c equal to or higher than 48 mmol/mol indicates diabetes	5 years
Prediabetes	Hba1c 43-47 indicates prediabetes	Baseline
Prediabetes	Hba1c 43-47 indicates prediabetes	1 year
Prediabetes	Hba1c 43-47 indicates prediabetes	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.	Baseline
Low density lipoprotein	Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.	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.	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.	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.	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	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	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	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	5 years
Elastography	Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better	Baseline
Elastography	Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better	5 years
FEV1/FVC	Indication of Chronic obstructive pulmonary disease as measured by spirometry	Baseline
FEV1/FVC	Indication of Chronic obstructive pulmonary disease as measured by spirometry	5 years
EKG	Under resting conditions, standard 12 lead electrocardiography	Baseline
EKG	Under resting conditions, standard 12 lead electrocardiography	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	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	5 years
Hand-grip force	Handgrip force: Higher is better, no defined cut-off value	Baseline
Hand-grip force	Handgrip force: Higher is better, no defined cut-off value	1 year
Hand-grip force	Handgrip force: Higher is better, no defined cut-off value	five years
Fat-free mass	Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value	Baseline
Fat-free mass	Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value	1 year
Fat-free mass	Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value	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	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	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	5 years
Body weight	Participants are weighed in light clothes with no shoes or pocket items, lower is better	Baseline
Body weight	Participants are weighed in light clothes with no shoes or pocket items, lower is better	1 year
Body weight	Participants are weighed in light clothes with no shoes or pocket items, lower is better	5 years
BMI	Body weight / m2, lower is better	Baseline
BMI	Body weight / m2, lower is better	1 year
BMI	Body weight / m2, lower is better	5 years
Waist circumference	Lower is better	Baseline
Waist circumference	Lower is better	1 year
Waist circumference	Lower is better	5 years
Work-ability Index	Measures the ability of a person to work, higher values are better, no cut-of value	Baseline
Work-ability Index	Measures the ability of a person to work, higher values are better, no cut-of value	5 years
Impact of weight on quality of life-lite	Measures weight associated quality of life, higher values are better, no cut-of value	Baseline
Impact of weight on quality of life-lite	Measures weight associated quality of life, higher values are better, no cut-of value	1 year
Impact of weight on quality of life-lite	Measures weight associated quality of life, higher values are better, no cut-of value	5 years
Adult Eating Behavior Questionnaire	Measures eating behavior and appetite traits, descriptive	Baseline
Adult Eating Behavior Questionnaire	Measures eating behavior and appetite traits, descriptive	1 year
Adult Eating Behavior Questionnaire	Measures eating behavior and appetite traits, descriptive	5 years
SDOI attitude to physical activity questionnaire	Measures a persons attitude to physical activity, higher is better, no cut-of value	baseline
SDOI attitude to physical activity questionnaire	Measures a persons attitude to physical activity, higher is better, no cut-of value	1 year
SDOI attitude to physical activity questionnaire	Measures a persons attitude to physical activity, higher is better, no cut-of value	5 years

Collaborators and Investigators

• Sponsor: Claus Bogh Juhl
• Collaborators: Odense University Hospital; Steno Diabetes Center Odense
• Investigators: Principal Investigator: Claus B Juhl, Prof. PhD MD, Hospital South West Jutland, University hospital of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: diabetes; Obesity; Hypertension; PCOS; Cohort; NAFLD; Hyperlipidemia; BMI; sleep apnea; Lifestyle intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: SDOI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No