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| Name | Class |
|---|---|
| Steno Diabetes Center Sjaelland | OTHER_GOV |
| Center for Clinical Research and Prevention | NETWORK |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bridge-building between municipality-based lifestyle programs and community-based physical activities | Behavioral | 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. |
| 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:
| From baseline (0 months) to follow-up (9 months) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Citizens with type 2 diabetes, cardiovascular disease and/or obesity in the municipality of Odsherred undergoing a municipality-based lifestyle program
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathias Ried-Larsen, PhD | Contact | 0045 35 45 06 99 | mathias.ried-larsen@regionh.dk | |
| Ida K Thorsen, PhD | Contact | 0045 35 45 76 41 | ida.kaer.thorsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Mathias Ried-Larsen, PhD | Centre for Physical Activity Research, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Physical Activity Research, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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) |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |