Clinical trial NCT05493345: Active Communities - Adherence to Physical Activity
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Cardiovascular Diseases
Obese
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Sjaelland
name: Center for Clinical Research and Prevention
First posted: 2022-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Citizens with type 2 diabetes, cardiovascular disease and/or obesity in the municipality of Odsherred undergoing a municipality-based lifestyle program

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and fidelity
timeFrame: From baseline (0 months) to follow-up (9 months)
Secondary outcomes:
measure: Moderate and vigorous physical activity (MVPA) time
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Sitting time
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Low-intensity physical activity (LPA) time
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Total physical activity (TPA) level
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Steps
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Six-minute walk distance
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Standing balance
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Body weight
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Fat mass
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Fat percentage
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Fat free mass
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Muscle mass
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Body mass index
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Mental well-being
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Risk of depression
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Physical health-related quality of life
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Mental health-related quality of life
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Perceived stress
timeFrame: From baseline (0 months) to follow-up (9 months)
measure: Loneliness
timeFrame: From baseline (0 months) to follow-up (9 months)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Centre for Physical Activity Research, Rigshospitalet
Study officials:
affiliation: Centre for Physical Activity Research, Rigshospitalet
name: Mathias Ried-Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: