Clinical trial NCT05708417: A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in SDOI
Official title: A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in The South Danish Obesity Initiative (SDOI).
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Health Related Quality of Life and Weight Condition
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a one-site, single-blind, clinical intervention study.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HRQoL .
timeFrame: 52 weeks
Secondary outcomes:
measure: General physical activity
timeFrame: 52 weeks
measure: Body perception
timeFrame: 52 weeks
measure: Isometric muscle strength
timeFrame: 52 weeks
measure: Self-esteem
timeFrame: 52 weeks
measure: Total cholesterol (mml/L)
timeFrame: 52 weeks
measure: Insulin resistance (HOMA-IR)
timeFrame: 52 weeks
measure: Diastolic and systolic Blood pressure (mm Hg)
timeFrame: 52 weeks
measure: Perceived chronic pain
timeFrame: 52 weeks
measure: Aerobic capacity
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of Southwest Denmark
state: Region Of Southern Denmark
Study officials:
affiliation: Hospital of South West Jutland, 6700 Esbjerg , Denmark
name: Claus Bogh Juhl, Professor
role: STUDY_DIRECTOR
References: