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Enrolling by Invitation

NCT Number: NCT05708417

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Southwest Denmark

Esbjerg, Region Syddanmark, 6700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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.

Placebo

Other

No lifestyle intervention within the study, only test/datacollection

Primary outcomes

  1. HRQoL .

    Time frame: 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 outcomes

  1. General physical activity

    Time frame: 52 weeks

    Measured by Accelerometer

  2. Body perception

    Time frame: 52 weeks

    Questionnaire

  3. Isometric muscle strength

    Time frame: 52 weeks

    Measured by Biodex dynanometer

  4. Self-esteem

    Time frame: 52 weeks

    Measured by questionnaire

  5. Total cholesterol (mml/L)

    Time frame: 52 weeks

    Blood sample

  6. Insulin resistance (HOMA-IR)

    Time frame: 52 weeks

    Blood sample

  7. Diastolic and systolic Blood pressure (mm Hg)

    Time frame: 52 weeks

    Blood pressure monitor

  8. Perceived chronic pain

    Time frame: 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

  9. Aerobic capacity

    Time frame: 52 weeks

    One-point Åstrand test

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 1, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.