Overweight and ObesityNCT06269159
The Power of 24-hour: Co-designing Intervention Components
An observational study of Overweight and Obesity, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Most of the existing lifestyle interventions in adults with overweight or obesity focus on one movement behavior in isolation (i.e. moderate to vigorous physical activity (MVPA)). Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Concept mapping: brainstorm and Concept mapping: clustering and rating
- How many people
- 210 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Sep 2023to 31 Mar 2025
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A group of health care providers as a group of adults with overweight and obesity will be included.
Who may be able to join
- The HCP will consist of physiotherapists and movement on referral coaches (https://www.gezondleven.be/projecten/bewegen-op-verwijzing). HCP are included when working on a healthy lifestyle as well as working with clients struggling with overweight or obesity.
- Group Adults with overweight and obesity
- Adults aged 25-64 years
- Active on the job market for at least 50 percent
- BMI ≥25kg/m²
Who cannot join
- - Retirement and early retirement
- Unemployment
- Working for less than 50 percent
- Working in night shifts
- Physical (e.g. amputations, paralysis, recovering from stroke, osteoarthritis), cognitive (e.g. dementia, psychological disorders) and major medical (e.g. Chronic respiratory diseases, heart failure, cardiovascular diseases, cancer) conditions that obstruct daily functioning
- Diabetes diagnosed by a general practitioner
Show all 12Show fewer
- Pregnancy
- Pregnancy <1 year ago
- Currently involved in study specific weight loss interventions
- Post-surgery weight loss interventions
- Waitlist for weight loss surgery
- Hospitalized
Trial locations and contacts
1 site in 1 country.
Marieke De Craemer contact
Belgium1 site, 1 recruiting
- Recruiting
Ghent university Hospital
Ghent, 9000
Bruno Lapauw, bruno.lapauw@uzgent.be
About this study
Official title: The Power of 24-hour: Co-designing Intervention Components to Stimulate 24-hour Movement Behaviors in Adults With Overweight and Obesity
Most of the existing lifestyle interventions in adults with overweight or obesity focus on one movement behavior in isolation (i.e. moderate to vigorous physical activity (MVPA)). However, recent research suggests to incorporate all movement behaviors performed in one day to explore the possible synergistic health effects of targeting more than one behavior. Moreover, more optimal 24-hour movement behavior compositions are related with better cardiometabolic health. Literature shows that adults with obesity have less optimal 24-hour compositions (8-9). Therefore it would be of interest to discover the needs related to an optimal 24-hour movement behavior intervention for a group of adults with overweight and obesity using co-design to develop an intervention.
This study will conduct a concept mapping protocol to explore the needs to of people with overweight and obesity to change their sedentary behavior into more physical activity as well to include the opinion of health care providers (HCP are physiotherapists) on the needs of their patients.
- Conditions
- Overweight and Obesity
- Being tested
- Concept mapping: brainstorm, Concept mapping: clustering and rating
- Keywords
- Concept mapping, physical activity, sedentary behavior, qualitative research
- Medical subject headings
- Overweight, Obesity, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concept mapping: brainstormOther
Group health care providers:
- Duration: 1.5 hour for HCP via zoom session
- Brainstorm question: what would help your clients to change their sedentary behavior into more physical activity?
Group adults with overweight and obesity
- Duration: online survey (REDCAP) of approx. 10 minutes
- Brainstorm question via an online survey. What would help you to change your sedentary behavior into more physical activity?
Concept mapping: clustering and ratingOther
The same participant of the brainstorm session are asked to join session 2 to complete the clustering and rating). All interested adults will get access to the online cluster and rate tool described below.
- Duration: flexible use of the online tool (available for two weeks)
- The clustering and rating of all needs mentioned in session 1 will be done online and individually via a web application. In this online tool, the final list of 'needs' generated in session 1 will be presented.
- Individually sort the 'needs' into groups and give the group a theme. In addition, each need will be scored on effectiviness, feasibility, modifiability. Thhe participants have unlimited access for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Health care providers | 10 health care providers: physiotherapist working with adults with overweight and obesity Receives: Other: Concept mapping: brainstorm; Other: Concept mapping: clustering and rating | |
| Adults with overweight and obesity | Inclusion criteria
* Adults aged 25-64 years
* Active on the job market for at least 50 percent
* BMI ≥25kg/m²
Exclusion criteria
* Retirement and early retirement
* Unemployment
* Working for less than 50 percent
* Working in night shifts
* Physical (e.g. amputations, paralysis, recovering from stroke, osteoarthritis), cognitive (e.g. dementia, psychological disorders) and major medical (e.g. Chronic respiratory diseases, heart failure, cardiovascular diseases, cancer) conditions that obstruct daily functioning
* Diabetes diagnosed by a general practitioner
* Pregnancy
* Pregnancy <1 year ago
* Currently involved in study specific weight loss interventions
* Post-surgery weight loss interventions
* Waitlist for weight loss surgery
* Hospitalized Receives: Other: Concept mapping: brainstorm; Other: Concept mapping: clustering and rating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes
Themes will be created that bundle different factors explaining needs to change sedentary behavior into more physical activity for both the group of health care providers as the group of adults with overweight and obesity
Measured: After session 2 clustering and rating
Score of effectiveness
Each need will be scored on effectiveness by both the health care providers as the groups adults with overweight and obesity.
How effective do you think the 'need' is. Likert scale of 1-5.
Measured: After session 2 clustering and rating
Score of feasibility
Each need will be scored on feasibility by both the health care providers as the groups adults with overweight and obesity. How feasible do you think the 'need' is. Likert scale of 1-5.
Measured: After session 2 clustering and rating
Score of modifiability
Each need will be scored on modifiability by both the health care providers as the groups adults with overweight and obesity. How modifiable do you think the 'need' is. Likert scale of 1-5.
Measured: After session 2 clustering and rating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start5 Sep 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Lapauw, Principal investigator, University Hospital, GhentMarieke De Craemer, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269159
- Sponsor's protocol ID
- ONZ-2023-0185
- Status last verified
- May 2024
- First submitted
- 13 Feb 2024
- Last updated
- 20 May 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Power of 24-hour: Co-designing Intervention Components to Stimulate 24-hour Movement Behaviors in Adults With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT06269159
- Acronym / sponsor ID
- ONZ-2023-0185
- Conditions
- Overweight and Obesity
- Keywords
- Concept mapping, physical activity, sedentary behavior, qualitative research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Feb 2024 (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.
Most of the existing lifestyle interventions in adults with overweight or obesity focus on one movement behavior in isolation (i.e. moderate to vigorous physical activity (MVPA)). However, recent research suggests to incorporate all movement behaviors performed in one day to explore the possible synergistic health effects of targeting more than one behavior. Moreover, more optimal 24-hour movement behavior compositions are related with better cardiometabolic health. Literature shows that adults with obesity have less optimal 24-hour compositions (8-9). Therefore it would be of interest to discover the needs related to an optimal 24-hour movement behavior intervention for a group of adults with overweight and obesity using co-design to develop an intervention.
This study will conduct a concept mapping protocol to explore the needs to of people with overweight and obesity to change their sedentary behavior into more physical activity as well to include the opinion of health care providers (HCP are physiotherapists) on the needs of their patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care providers | – | Other: Concept mapping: brainstorm, Other: Concept mapping: clustering and rating10 health care providers: physiotherapist working with adults with overweight and obesity |
| Adults with overweight and obesity | – | Other: Concept mapping: brainstorm, Other: Concept mapping: clustering and ratingInclusion criteria * Adults aged 25-64 years * Active on the job market for at least 50 percent * BMI ≥25kg/m² Exclusion criteria * Retirement and early retirement * Unemployment * Working for less than 50 percent * Working in night shifts * Physical (e.g. amputations, paralysis, recovering from stroke, osteoarthritis), cognitive (e.g. dementia, psychological disorders) and major medical (e.g. Chronic respiratory diseases, heart failure, cardiovascular diseases, cancer) conditions that obstruct daily functioning * Diabetes diagnosed by a general practitioner * Pregnancy * Pregnancy <1 year ago * Currently involved in study specific weight loss interventions * Post-surgery weight loss interventions * Waitlist for weight loss surgery * Hospitalized |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A group of health care providers as a group of adults with overweight and obesity will be included.
Key inclusion criteria (5 listed)
- The HCP will consist of physiotherapists and movement on referral coaches (https://www.gezondleven.be/projecten/bewegen-op-verwijzing). HCP are included when working on a healthy lifestyle as well as working with clients struggling with overweight or obesity.
- Group Adults with overweight and obesity
- Adults aged 25-64 years
- Active on the job market for at least 50 percent
- BMI ≥25kg/m²
Key exclusion criteria (12 listed)
- - Retirement and early retirement
- Unemployment
- Working for less than 50 percent
- Working in night shifts
- Physical (e.g. amputations, paralysis, recovering from stroke, osteoarthritis), cognitive (e.g. dementia, psychological disorders) and major medical (e.g. Chronic respiratory diseases, heart failure, cardiovascular diseases, cancer) conditions that obstruct daily functioning
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 |
|---|---|---|
| Concept mapping: brainstormGroup health care providers: * Duration: 1.5 hour for HCP via zoom session * Brainstorm question: what would help your clients to change their sedentary behavior into more physical activity? Group adults with overweight and obesity * Duration: online survey (REDCAP) of approx. 10 minutes * Brainstorm question via an online survey. What would help you to change your sedentary behavior into more physical activity? | Other | Adults with overweight and obesity, Health care providers |
| Concept mapping: clustering and ratingThe same participant of the brainstorm session are asked to join session 2 to complete the clustering and rating). All interested adults will get access to the online cluster and rate tool described below. * Duration: flexible use of the online tool (available for two weeks) * The clustering and rating of all needs mentioned in session 1 will be done online and individually via a web application. In this online tool, the final list of 'needs' generated in session 1 will be presented. * Individually sort the 'needs' into groups and give the group a theme. In addition, each need will be scored on effectiviness, feasibility, modifiability. Thhe participants have unlimited access for two weeks. | Other | Adults with overweight and obesity, Health care providers |
Primary outcome
Themes
Time frame: After session 2 clustering and rating
Themes will be created that bundle different factors explaining needs to change sedentary behavior into more physical activity for both the group of health care providers as the group of adults with overweight and obesity
Score of effectiveness
Time frame: After session 2 clustering and rating
Each need will be scored on effectiveness by both the health care providers as the groups adults with overweight and obesity. How effective do you think the 'need' is. Likert scale of 1-5.
Score of feasibility
Time frame: After session 2 clustering and rating
Each need will be scored on feasibility by both the health care providers as the groups adults with overweight and obesity. How feasible do you think the 'need' is. Likert scale of 1-5.
Score of modifiability
Time frame: After session 2 clustering and rating
Each need will be scored on modifiability by both the health care providers as the groups adults with overweight and obesity. How modifiable do you think the 'need' is. Likert scale of 1-5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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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.
Marieke De Craemer contact
Bruno Lapauw principal investigator
University Hospital, Ghent
Marieke De Craemer principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 12 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 20 May 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 Belgium. 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. 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?
Contact Iris Willems (093323638, willems.iris@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Themes (time frame: After session 2 clustering and rating). The study lists 4 primary outcomes in all. 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 20 May 2024.