NCT05493345

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

August 5, 2022

Last Update Submit

August 5, 2022

Conditions

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (19)

  • Moderate and vigorous physical activity (MVPA) time

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

  • Sitting time

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

  • Low-intensity physical activity (LPA) time

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

  • Total physical activity (TPA) level

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

  • Steps

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

  • +14 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • reliant on a wheelchair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Physical Activity Research, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mathias Ried-Larsen, PhD

    Centre for Physical Activity Research, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor and Senior researcher

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 9, 2022

Study Start

August 5, 2022

Primary Completion

September 1, 2023

Study Completion

August 1, 2024

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations