Active Communities - Adherence to Physical Activity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Active Communities - Adherence to Physical Activity Among Persons With Type 2 Diabetes, Cardiovascular Disease and/or Obesity - With a Focus on IT as a Tool

Conditions
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Diabetes Mellitus, Type 2, Cardiovascular Diseases, Obese

Intervention / Treatment
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* Behavioral: Bridge-building between municipality-based lifestyle programs and community-based physical activities


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate and vigorous physical activity (MVPA) time | Change in time spend in MVPA (Accelerometer AX3) | From baseline (0 months) to follow-up (9 months) | 
| Sitting time | Change in time spend sitting (Accelerometer AX3) | From baseline (0 months) to follow-up (9 months) | 
| Low-intensity physical activity (LPA) time | Change in time spend in LPA (Accelerometer AX3) | From baseline (0 months) to follow-up (9 months) | 
| 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) | 
| Steps | Change in number of steps (Acceleromter AX3) | From baseline (0 months) to follow-up (9 months) | 
| 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) | 
| Standing balance | Change in time spend in three standing positions (0-30 sec) | From baseline (0 months) to follow-up (9 months) | 
| Body weight | Change in body weight (bioimpedance scale) | From baseline (0 months) to follow-up (9 months) | 
| Fat mass | Change in fat mass (bioimpedance scale) | From baseline (0 months) to follow-up (9 months) | 
| Fat percentage | Change in fat percentage (bioimpedance scale) | From baseline (0 months) to follow-up (9 months) | 
| Fat free mass | Change in fat free mass (bioimpedance scale) | From baseline (0 months) to follow-up (9 months) | 
| Muscle mass | Change in muscle mass (bioimpedance scale) | From baseline (0 months) to follow-up (9 months) | 
| Body mass index | Change in body mass index (BMI) | From baseline (0 months) to follow-up (9 months) | 
| Mental well-being | Change in 5-item World Health Organization well-being index (WHO-5) | From baseline (0 months) to follow-up (9 months) | 
| Risk of depression | Change in number of participants scoring <50 in the WHO-5 | From baseline (0 months) to follow-up (9 months) | 
| Physical health-related quality of life | Change in the SF-12 physical component summary (PCS) | From baseline (0 months) to follow-up (9 months) | 
| Mental health-related quality of life | Change in the SF-12 mental component summary (MCS) | From baseline (0 months) to follow-up (9 months) | 
| Perceived stress | Change in perceived stress scale (PSS) score | From baseline (0 months) to follow-up (9 months) | 
| Loneliness | Change in Three-Item Loneliness Scale (T-ILS) score | From baseline (0 months) to follow-up (9 months) |