The Power of 24-hour: Co-designing Intervention Components

Overweight and Obesity Clinical Trial

Official title:

The Power of 24-hour: Co-designing Intervention Components to Stimulate 24-hour Movement Behaviors in Adults With Overweight and Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269159
• Other study ID #: ONZ-2023-0185
• Status: Recruiting
• Start date: September 5, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Ghent
• Contact: Iris Willems
• Phone: 093323638
• Email: willems.iris[@]ugent.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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)). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Group Health Care providers

Inclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Other:
• Concept mapping: brainstorm
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 rating
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.

Locations

Country	Name	City	State
Belgium	Ghent university Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	After session 2 clustering and rating
Primary	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.	After session 2 clustering and rating
Primary	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.	After session 2 clustering and rating
Primary	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.	After session 2 clustering and rating