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Enrolling by invitation NCT05708417

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

No phase Interventional Health Related Quality of Life and Weight Condition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lifestyle Intervention, Placebo.
Who it may be relevant to
Registry conditions: Health Related Quality of Life and Weight Condition. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral Lifestyle 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.
  • Other Placebo
    No lifestyle intervention within the study, only test/datacollection

Primary outcome measures

  • HRQoL . [Time frame: 52 weeks]
Secondary outcome measures (9)
  • General physical activity [Time frame: 52 weeks]
  • Body perception [Time frame: 52 weeks]
  • Isometric muscle strength [Time frame: 52 weeks]
  • Self-esteem [Time frame: 52 weeks]
  • Total cholesterol (mml/L) [Time frame: 52 weeks]
  • Insulin resistance (HOMA-IR) [Time frame: 52 weeks]
  • Diastolic and systolic Blood pressure (mm Hg) [Time frame: 52 weeks]
  • Perceived chronic pain [Time frame: 52 weeks]
  • Aerobic capacity [Time frame: 52 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Denmark · 1 center
  • Hospital of Southwest Denmark — Esbjerg

Identifiers

NCT: NCT05708417 · Lifestyle_intervention_SDOI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗