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

A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in The South Danish Obesity Initiative (SDOI).

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05708417
Enrollment
120
Registered
2023-02-01
Start date
2023-02-01
Completion date
2026-02-01
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Related Quality of Life and Weight Condition

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.

Interventions

BEHAVIORALLifestyle Intervention

The intervention in SDOI has the predominantly focus on each individual reflection and realisation and is built upon ACT' six core processes: 1) Acceptance, 2) Cognitive defusion 3) Being present, 4) Self as context, 5) Values, and 6) Committed action. The program is based on up to 13 times attendance within the 12 months intervention period.

OTHERPlacebo

No lifestyle intervention within the study, only test/datacollection

Sponsors

Esbjerg Hospital - University Hospital of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention model description

The study is a one-site, single-blind, clinical intervention study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HRQoL .52 weeksMeasured 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

MeasureTime frameDescription
Body perception52 weeksQuestionnaire
Isometric muscle strength52 weeksMeasured by Biodex dynanometer
Self-esteem52 weeksMeasured by questionnaire
Total cholesterol (mml/L)52 weeksBlood sample
General physical activity52 weeksMeasured by Accelerometer
Diastolic and systolic Blood pressure (mm Hg)52 weeksBlood pressure monitor
Perceived chronic pain52 weeksMeasured 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
Aerobic capacity52 weeksOne-point Åstrand test
Insulin resistance (HOMA-IR)52 weeksBlood sample

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026