Active Communities - Adherence to Physical Activity

August 5, 2022 updated by: Mathias Ried-Larsen, Rigshospitalet, Denmark

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility and fidelity
Time Frame: From baseline (0 months) to follow-up (9 months)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Moderate and vigorous physical activity (MVPA) time
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in time spend in MVPA (Accelerometer AX3)
From baseline (0 months) to follow-up (9 months)
Sitting time
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in time spend sitting (Accelerometer AX3)
From baseline (0 months) to follow-up (9 months)
Low-intensity physical activity (LPA) time
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in time spend in LPA (Accelerometer AX3)
From baseline (0 months) to follow-up (9 months)
Total physical activity (TPA) level
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in TPA measured in counts per minute (CPM) (Accelerometer AX3)
From baseline (0 months) to follow-up (9 months)
Steps
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in number of steps (Acceleromter AX3)
From baseline (0 months) to follow-up (9 months)
Six-minute walk distance
Time Frame: From baseline (0 months) to follow-up (9 months)
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
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in time spend in three standing positions (0-30 sec)
From baseline (0 months) to follow-up (9 months)
Body weight
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in body weight (bioimpedance scale)
From baseline (0 months) to follow-up (9 months)
Fat mass
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in fat mass (bioimpedance scale)
From baseline (0 months) to follow-up (9 months)
Fat percentage
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in fat percentage (bioimpedance scale)
From baseline (0 months) to follow-up (9 months)
Fat free mass
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in fat free mass (bioimpedance scale)
From baseline (0 months) to follow-up (9 months)
Muscle mass
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in muscle mass (bioimpedance scale)
From baseline (0 months) to follow-up (9 months)
Body mass index
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in body mass index (BMI)
From baseline (0 months) to follow-up (9 months)
Mental well-being
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in 5-item World Health Organization well-being index (WHO-5)
From baseline (0 months) to follow-up (9 months)
Risk of depression
Time Frame: From baseline (0 months) to follow-up (9 months)
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
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in the SF-12 physical component summary (PCS)
From baseline (0 months) to follow-up (9 months)
Mental health-related quality of life
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in the SF-12 mental component summary (MCS)
From baseline (0 months) to follow-up (9 months)
Perceived stress
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in perceived stress scale (PSS) score
From baseline (0 months) to follow-up (9 months)
Loneliness
Time Frame: From baseline (0 months) to follow-up (9 months)
Change in Three-Item Loneliness Scale (T-ILS) score
From baseline (0 months) to follow-up (9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Steno Diabetes Center Sjaelland
Center for Clinical Research and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mathias Ried-Larsen, PhD, Centre for Physical Activity Research, Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21076311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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