A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in SDOI

Not Applicable

• Conditions: Health Related Quality of Life and Weight Condition

• Registration Number: NCT05708417
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

Brief Summary

The study aim is to evaluate a patient-centred intervention focusing on improved quality of life and wellbeing among individuals with obesity and risk factors for adverse outcome.

Detailed Description

In Denmark, University Hospital of Southern Denmark in Esbjerg has initiated The South Danish Obesity Initiative (SDOI) to optimize the treatment of and the research in obesity. The hospital has for years, offered treatment to individuals with obesity, however, SDOI is an investigation program with the aim to identify people with undiagnosed obesity-related diseases by a systematic and stepwise approach, delivering an up-to-date treatment of diagnosed diseases and offering personalized lifestyle advice based on the finding in the investigation program. The SDOI program comprises collaboration between different medical departments at the hospital and furthermore, entails the establishment of a well-defined cohort as a basis for research. ACT is of interest in the construction of the personalized lifestyle advice in the SDOI program. However, there is limited research available on the effect of the behaviour therapy ACT as a basic method for a lifestyle program targeting overweight individuals who have been made aware of obesity related diseases and re-conditions. ACT might be a valuable tool to assist these individuals to increase their quality of life and thereby, ability to make lifestyle changes.

Study Timeline

• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-23
• Study Start: 2023-02-01
• Study First Posted: 2023-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Participants will be eligible for inclusion if they are ≥18 years
• Body mass index above 30 kg/m2

Exclusion Criteria

• Individuals referred for bariatric surgery will not be eligible for inclusion in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HRQoL .	52 weeks	Measured by the questionnaire Impact of Weight on Quality of Life-Lite at week 52. Scores range from 0 to 100, with 100 representing the best quality of life.

Secondary Outcome Measures

Name	Time	Method
Self-esteem	52 weeks	Measured by questionnaire
General physical activity	52 weeks	Measured by Accelerometer
Isometric muscle strength	52 weeks	Measured by Biodex dynanometer
Aerobic capacity	52 weeks	One-point Åstrand test
Body perception	52 weeks	Questionnaire
Total cholesterol (mml/L)	52 weeks	Blood sample
Diastolic and systolic Blood pressure (mm Hg)	52 weeks	Blood pressure monitor
Insulin resistance (HOMA-IR)	52 weeks	Blood sample
Perceived chronic pain	52 weeks	Measured on VAS scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100

Trial Locations

Locations (1)

Hospital of Southwest Denmark; 🇩🇰 Esbjerg, Region Of Southern Denmark, Denmark