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

March 13, 2023 updated by: Hospital of South West Jutland

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

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Region Of Southern Denmark
      • Esbjerg, Region Of Southern Denmark, Denmark, 6700
        • Hospital of Southwest Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weight neutral intervention

The intervention is based on the concept of Acceptance and Commitment Therapy (ACT) and is conducted by specially trained physiotherapist and a dietician. The intervention in SDOI has the predominantly focus on each individual reflection and realization and is built upon ACT' six core processes. Specific focus on teach participant with different narrative and background and on coaching and back-and-forth dialogue with physiotherapist and dietician. The program is based on up to 13 times attendance within the 12 months intervention period. Part 1: Three to five individual coaching, Part 2: six group sessions and Part 3: one or two individual coaching.

Compliance to the intervention is classified as 'good' if the participants participate for a minimum four out of six group sessions, a minimum three out of five initial individual coaching and a minimum one out of two individual coaching post 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.

Placebo Comparator: Reference group
The reference group will not receive the intervention in the study and only participate in the test/data collection. The reference group will established consisting of participants participating in the SDOI program but, who of some reasons have refused participating in the lifestyle program. In case of insufficient recruitment of participants to the reference group, individuals meeting inclusion criteria such as age and BMI will be recruited via advertising in local newspapers and social media.
No lifestyle intervention within the study, only test/datacollection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General physical activity
Time Frame: 52 weeks
Measured by Accelerometer
52 weeks
Body perception
Time Frame: 52 weeks
Questionnaire
52 weeks
Isometric muscle strength
Time Frame: 52 weeks
Measured by Biodex dynanometer
52 weeks
Self-esteem
Time Frame: 52 weeks
Measured by questionnaire
52 weeks
Total cholesterol (mml/L)
Time Frame: 52 weeks
Blood sample
52 weeks
Insulin resistance (HOMA-IR)
Time Frame: 52 weeks
Blood sample
52 weeks
Diastolic and systolic Blood pressure (mm Hg)
Time Frame: 52 weeks
Blood pressure monitor
52 weeks
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
52 weeks
Aerobic capacity
Time Frame: 52 weeks
One-point Åstrand test
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Claus Bogh Juhl, Professor, Hospital of South West Jutland, 6700 Esbjerg , Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2026

Study Completion (Anticipated)

February 1, 2026

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Lifestyle_intervention_SDOI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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