- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05708417
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).
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bibi Gram, PhD
- Phone Number: + 45 79182000
- Email: Bibi.Valgerdur.Gram@rsyd.dk
Study Contact Backup
- Name: Claus Bogh Juel, PhD
- Phone Number: + 45 79182000
- Email: Claus.Bogh.Juhl@rsyd.dk
Study Locations
-
-
Region Of Southern Denmark
-
Esbjerg, Region Of Southern Denmark, Denmark, 6700
- Hospital of Southwest Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Study Director: Claus Bogh Juhl, Professor, Hospital of South West Jutland, 6700 Esbjerg , Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lifestyle_intervention_SDOI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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