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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05493345
Other study ID # 21076311
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 5, 2022
Est. completion date August 1, 2024

Study information

Verified date August 2022
Source Rigshospitalet, Denmark
Contact Mathias Ried-Larsen, PhD
Phone 0045 35 45 06 99
Email mathias.ried-larsen@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary aim of this study is to investigate whether a number of co-created bridge-building activities between municipality-based lifestyle programs and community-based physical activities (e.g. local sports and exercise associations) can support persons with type 2 diabetes, cardiovascular disease and/or obesity in maintain physical activity levels.


Description:

This study is an evaluation of a number of co-created bridge-building activities between municipality-based lifestyle programs and community-based physical activities. Persons with type 2 diabetes, cardiovascular disease and/or obesity initiating a lifestyle program (8-12 weeks duration) in the municipality of Odsherred, Denmark, will be included in the study. We will include sixty (n=60) persons or the number of persons recruited at the end of the recruitment period, December 1, 2022 - whichever is reached first. Participants will undergo objective measurement of physical activity level, test of standing balance, 6-minute walk test, measurement of body composition, and answer questionnaires related to their background (education, job situation, civil status), health, lifestyle and well-being. Measurements will be performed before and after participants undergo a lifestyle program, and 3 and 6 months after termination of the lifestyle program.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 1, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Citizens in the municipality of Odsherred undergoing a municipality-based lifestyle program - Obese, or diagnosed with type 2 diabetes or cardiovascular disease Exclusion Criteria: - reliant on a wheelchair

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Bridge-building between municipality-based lifestyle programs and community-based physical activities
Four co-created bridge-building activities has been implemented in the municipality of Odsherred, including (1) A digital portal for information and sharing of knowledge, (2) Visits between municipal rehabilitation programs and community-based physical activities, (3) Co-created teams for the target group, and (4) a 'Bridge builder' coordinator.

Locations

Country Name City State
Denmark Centre for Physical Activity Research, Rigshospitalet Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Center for Clinical Research and Prevention, Steno Diabetes Center Sjaelland

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility and fidelity Feasibility and fidelity are evaluated using research progression criteria. Every domain is scored as either 1) Progress to RCT (randomized controlled trial) (green), 2) Amend before progressing to RCT (amber) or 3 do not progress to RCT (red).
Domains include:
Satisfaction with project activities
Recruitment rate
Test- and participation burden
Retainment
Referral rate
Adherence
Physical activity improvement
From baseline (0 months) to follow-up (9 months)
Secondary Moderate and vigorous physical activity (MVPA) time Change in time spend in MVPA (Accelerometer AX3) From baseline (0 months) to follow-up (9 months)
Secondary Sitting time Change in time spend sitting (Accelerometer AX3) From baseline (0 months) to follow-up (9 months)
Secondary Low-intensity physical activity (LPA) time Change in time spend in LPA (Accelerometer AX3) From baseline (0 months) to follow-up (9 months)
Secondary Total physical activity (TPA) level Change in TPA measured in counts per minute (CPM) (Accelerometer AX3) From baseline (0 months) to follow-up (9 months)
Secondary Steps Change in number of steps (Acceleromter AX3) From baseline (0 months) to follow-up (9 months)
Secondary Six-minute walk distance Change in distance walked in a period of 6 minutes (6-minute walk test) From baseline (0 months) to follow-up (9 months)
Secondary Standing balance Change in time spend in three standing positions (0-30 sec) From baseline (0 months) to follow-up (9 months)
Secondary Body weight Change in body weight (bioimpedance scale) From baseline (0 months) to follow-up (9 months)
Secondary Fat mass Change in fat mass (bioimpedance scale) From baseline (0 months) to follow-up (9 months)
Secondary Fat percentage Change in fat percentage (bioimpedance scale) From baseline (0 months) to follow-up (9 months)
Secondary Fat free mass Change in fat free mass (bioimpedance scale) From baseline (0 months) to follow-up (9 months)
Secondary Muscle mass Change in muscle mass (bioimpedance scale) From baseline (0 months) to follow-up (9 months)
Secondary Body mass index Change in body mass index (BMI) From baseline (0 months) to follow-up (9 months)
Secondary Mental well-being Change in 5-item World Health Organization well-being index (WHO-5) From baseline (0 months) to follow-up (9 months)
Secondary Risk of depression Change in number of participants scoring <50 in the WHO-5 From baseline (0 months) to follow-up (9 months)
Secondary Physical health-related quality of life Change in the SF-12 physical component summary (PCS) From baseline (0 months) to follow-up (9 months)
Secondary Mental health-related quality of life Change in the SF-12 mental component summary (MCS) From baseline (0 months) to follow-up (9 months)
Secondary Perceived stress Change in perceived stress scale (PSS) score From baseline (0 months) to follow-up (9 months)
Secondary Loneliness Change in Three-Item Loneliness Scale (T-ILS) score From baseline (0 months) to follow-up (9 months)
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