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

NCT ID: NCT06269159

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-05
• Study Completion Date: 2025-03-31

Brief 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.

Conditions

Overweight and Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Health care providers

10 health care providers: physiotherapist working with adults with overweight and obesity

Concept mapping: brainstorm

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

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

Concept mapping: brainstorm

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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?

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Lapauw

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Marieke De Craemer

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Ghent university Hospital

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Iris Willems

Role: CONTACT

willems.iris@ugent.be

093323638

Marieke De Craemer

Role: CONTACT

Marieke.decraemer@ugent.be

Facility Contacts

Bruno Lapauw

Role: primary

bruno.lapauw@uzgent.be

Other Identifiers

ONZ-2023-0185

Identifier Type: -

Identifier Source: org_study_id