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Diabetes Mellitus, Type 2NCT05493345

Active Communities - Adherence to Physical Activity

An observational study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bridge-building between municipality-based lifestyle programs and community-based physical activities
How many people
60 participants
Where
1 siteDenmark
Study dates
5 Aug 2022to 1 Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Citizens with type 2 diabetes, cardiovascular disease and/or obesity in the municipality of Odsherred undergoing a municipality-based lifestyle program

Who may be able to join

  • Citizens in the municipality of Odsherred undergoing a municipality-based lifestyle program
  • Obese, or diagnosed with type 2 diabetes or cardiovascular disease

Who cannot join

  • reliant on a wheelchair

Trial locations and contacts

1 site in 1 country.

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

Denmark1 site, 1 recruiting

  • Centre for Physical Activity Research, Rigshospitalet

    Copenhagen, 2100

    Mathias Ried-Larsen, PhD, 0045 35 45 06 99, mathias.ried-larsen@regionh.dk

    Inge Holm, 0045 35 45 76 21, inge.holm@regionh.dk

    Recruiting

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Bridge-building between municipality-based lifestyle programs and community-based physical activities
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bridge-building between municipality-based lifestyle programs and community-based physical activitiesBehavioural

    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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From baseline (0 months) to follow-up (9 months)

Secondary outcomes (19)

  1. Moderate and vigorous physical activity (MVPA) time

    Change in time spend in MVPA (Accelerometer AX3)

    Measured: From baseline (0 months) to follow-up (9 months)

  2. Sitting time

    Change in time spend sitting (Accelerometer AX3)

    Measured: From baseline (0 months) to follow-up (9 months)

  3. Low-intensity physical activity (LPA) time

    Change in time spend in LPA (Accelerometer AX3)

    Measured: From baseline (0 months) to follow-up (9 months)

  4. Total physical activity (TPA) level

    Change in TPA measured in counts per minute (CPM) (Accelerometer AX3)

    Measured: From baseline (0 months) to follow-up (9 months)

  5. Steps

    Change in number of steps (Acceleromter AX3)

    Measured: From baseline (0 months) to follow-up (9 months)

  6. Six-minute walk distance

    Change in distance walked in a period of 6 minutes (6-minute walk test)

    Measured: From baseline (0 months) to follow-up (9 months)

  7. Standing balance

    Change in time spend in three standing positions (0-30 sec)

    Measured: From baseline (0 months) to follow-up (9 months)

  8. Body weight

    Change in body weight (bioimpedance scale)

    Measured: From baseline (0 months) to follow-up (9 months)

  9. Fat mass

    Change in fat mass (bioimpedance scale)

    Measured: From baseline (0 months) to follow-up (9 months)

  10. Fat percentage

    Change in fat percentage (bioimpedance scale)

    Measured: From baseline (0 months) to follow-up (9 months)

  11. Fat free mass

    Change in fat free mass (bioimpedance scale)

    Measured: From baseline (0 months) to follow-up (9 months)

  12. Muscle mass

    Change in muscle mass (bioimpedance scale)

    Measured: From baseline (0 months) to follow-up (9 months)

  13. Body mass index

    Change in body mass index (BMI)

    Measured: From baseline (0 months) to follow-up (9 months)

  14. Mental well-being

    Change in 5-item World Health Organization well-being index (WHO-5)

    Measured: From baseline (0 months) to follow-up (9 months)

  15. Risk of depression

    Change in number of participants scoring <50 in the WHO-5

    Measured: From baseline (0 months) to follow-up (9 months)

  16. Physical health-related quality of life

    Change in the SF-12 physical component summary (PCS)

    Measured: From baseline (0 months) to follow-up (9 months)

  17. Mental health-related quality of life

    Change in the SF-12 mental component summary (MCS)

    Measured: From baseline (0 months) to follow-up (9 months)

  18. Perceived stress

    Change in perceived stress scale (PSS) score

    Measured: From baseline (0 months) to follow-up (9 months)

  19. Loneliness

    Change in Three-Item Loneliness Scale (T-ILS) score

    Measured: From baseline (0 months) to follow-up (9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2022
  2. Study start5 Aug 2022
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05493345
Sponsor's protocol ID
21076311
Status last verified
Aug 2022
First submitted
5 Aug 2022
Last updated
9 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mathias Ried-Larsen, PhD (0045 35 45 06 99, mathias.ried-larsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and fidelity (time frame: From baseline (0 months) to follow-up (9 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05493345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.

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