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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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 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

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

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

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

Rigshospitalet, Denmark

Collaborators

Steno Diabetes Center Sjaelland
Center for Clinical Research and Prevention

Investigators

  • 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)

August 5, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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