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

NCT06269159 | Recruiting

• 1 other identifier: ONZ-2023-0185
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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

Keywords

Concept mapping; physical activity; sedentary behavior; qualitative research

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Health care providers

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

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

Other: Concept mapping: brainstorm; Other: Concept mapping: clustering and rating

Interventions

Concept mapping: brainstorm 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?

Adults with overweight and obesity; Health care providers

Concept mapping: clustering and rating 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; Health care providers

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A group of health care providers as a group of adults with overweight and obesity will be included.

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent university Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Bruno Lapauw

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Marieke De Craemer

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Willems

CONTACT

093323638; willems.iris@ugent.be

Marieke De Craemer

CONTACT

Marieke.decraemer@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: September 5, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

BE (1)