Health Related Quality of Life and Weight ConditionNCT05708417
A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in SDOI
A study testing Lifestyle Intervention in people with Health Related Quality of Life and Weight Condition, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Related Quality of Life and Weight Condition
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be eligible for inclusion if they are ≥18 years
- Body mass index above 30 kg/m2
Who cannot join
- Individuals referred for bariatric surgery will not be eligible for inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Lifestyle Intervention, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
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.
PlaceboOther
No lifestyle intervention within the study, only test/datacollection
| Study group | Role | What they receive |
|---|---|---|
| Weight neutral intervention | Experimental | 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. Receives: Behavioral: Lifestyle Intervention |
| Reference group | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL .
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.
Measured: 52 weeks
Secondary outcomes (9)
General physical activity
Measured by Accelerometer
Measured: 52 weeks
Body perception
Questionnaire
Measured: 52 weeks
Isometric muscle strength
Measured by Biodex dynanometer
Measured: 52 weeks
Self-esteem
Measured by questionnaire
Measured: 52 weeks
Total cholesterol (mml/L)
Blood sample
Measured: 52 weeks
Insulin resistance (HOMA-IR)
Blood sample
Measured: 52 weeks
Diastolic and systolic Blood pressure (mm Hg)
Blood pressure monitor
Measured: 52 weeks
Perceived chronic pain
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
Measured: 52 weeks
Aerobic capacity
One-point Åstrand test
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Related Quality of Life and Weight ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study is a one-site, single-blind, clinical intervention study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Bogh Juhl, Professor, Study director, Hospital of South West Jutland, 6700 Esbjerg , Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708417
- Sponsor's protocol ID
- Lifestyle_intervention_SDOI
- Status last verified
- Sep 2024
- First submitted
- 13 Jan 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in The South Danish Obesity Initiative (SDOI).
- ClinicalTrials.gov ID
- NCT05708417
- Acronym / sponsor ID
- Lifestyle_intervention_SDOI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study is a one-site, single-blind, clinical intervention study.
| Arm | Type | Receives |
|---|---|---|
| Weight neutral intervention | Experimental | Behavioral: Lifestyle InterventionThe 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. |
| Reference group | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will be eligible for inclusion if they are ≥18 years
- Body mass index above 30 kg/m2
Key exclusion criteria (1 listed)
- Individuals referred for bariatric surgery will not be eligible for inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionThe 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. | Behavioural | Weight neutral intervention |
| PlaceboNo lifestyle intervention within the study, only test/datacollection | Other | Reference group |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
Related trials for Health Related Quality of Life and Weight Condition
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
Neurodevelopment Outcome, Linear Growth
RecruitingObservational study
Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Mental Health, Child Wellbeing
Not yet recruiting
Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Not yet recruiting
ProGo Menopause Wellbeing Study
Menopause Related Conditions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Bogh Juhl, Professor study director
Hospital of South West Jutland, 6700 Esbjerg , Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Health Related Quality of Life and Weight Condition, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL . (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.