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Cardiovascular DiseasesTLCNCT03807323

Tools for Lasting Lifestyle Changes

A study testing Lifestyle counselling and exercise in people with Cardiovascular Diseases and Lifestyle Risk Reduction, run by University of Tromso at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pilot and feasibility study; a complex intervention focusing on lifestyle change to increase physical activity and reduce cardiovascular disease (CVD) risk among high risk individuals. Read more about this study

Who is it for?
Ages 55 to 75 years
What is being tested?
Lifestyle counselling and exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteNorway
Study dates
25 Sep 2017to 4 Oct 2018
Phase
Interventional
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 55 to 75 years
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 55-74 years
  • BMI> 30
  • Moderate elevated NORRISK 2 score
  • Motivation for lifestyle change
  • Has agreed to attend and participate in a student study during the study period
  • Exclusion criteria: 1.External disease with short life expectancy 2.Diseases that limit physical activity in the project 3.Serious mental illness 4. Previous myocardial infarction 5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack
  • 5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack:

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • UiT the Arctic University of Norway

    Tromsø, 9037

Other trials in Norway

About this study

Official title: New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)

Pilot and feasibility study; a complex intervention focusing on lifestyle change to increase physical activity and reduce cardiovascular disease (CVD) risk among high risk individuals.

Read the detailed description

Interdisciplinary, mixed-method, prospective and single-arm exploratory study aimed to explore study feasibility, responsiveness, participants adherence and adverse events among the participants before deciding to proceed to full-scale evaluation.

Enrollment of max. 20 obese people (BMI>30) with sedentary lifestyle and increased CVD-risk (NORRISK2)..

Participants general health status including cardiopulmonary fitness will be assessed both before and after the intervention (blood pressure, ECG, spirometry, treadmill tests VO2max, blood tests, body composition by Dual-energy X-ray absorptiometry (DEXA) measurements) Participants´ functional capacity assessed by several range of motion tests. Participants nutritional and psychological status assessed by validated questionnaires.

Several blood-tests and ECG will be recorded at three months.

Daily activity level during and six months after the intervention period monitored by Polar M430 pulse watch.

The participants will be interviewed with focus on their prior health, activity habits and intervention experiences at three months and six months after end of the intervention. Two focus-group interviews at end of intervention.

Being tested
Lifestyle counselling and exercise
Keywords
Primary intervention
Medical subject headings
Cardiovascular Diseases, Risk Reduction Behavior

What participants receive

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

  • Lifestyle counselling and exerciseBehavioural

    The program consists of:

    1. Instructor-led training twice a week,
    2. One individual nutritionist counselling session of followed by three group based two-hour nutritionist counselling focusing on practical food purchase and preparation and
    3. Three two-hour psychologist-led group counselling sessions based on implementation intentions theory and practical help to make if-then plans focusing on changing food and activity habits.
Study groups in NCT03807323
Study groupRoleWhat they receive
'Lifestyle counselling and exercise' .ExperimentalThe study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' .
Receives: Behavioral: Lifestyle counselling and exercise

What is being measured

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

  1. Change from baseline physical activity at 6 months

    Change from baseline steps counted by activity trackers (Polar M430) at 6 months

    Measured: 6 months

Secondary outcomes (2)

  1. Change from baseline central obesity at 6 months

    Change from baseline waist circumference (cm) at 6 months standardized measured

    Measured: 6 months

  2. Change from baseline VO2max at 6 months

    Change from baseline VO2max at 6 months measured on treadmill test

    Measured: 6 months

Timeline

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

  1. First posted16 Jan 2019
  2. Study start25 Sep 2017
  3. Primary completion4 Oct 2018
  4. Study completion4 Oct 2018

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility study
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03807323
Sponsor's protocol ID
2017-1100
Acronym
TLC
Status last verified
Jan 2019
First submitted
16 Nov 2018
Last updated
16 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deraas TS, Hopstock L, Henriksen A, Morseth B, Sand AS, Njolstad I, Pedersen S, Sagelv E, Johansson J, Grimsgaard S. Complex lifestyle intervention among inactive older adults with elevated cardiovascular disease risk and obesity: a mixed-method, single-arm feasibility study for RESTART-a randomized controlled trial. Pilot Feasibility Stud. 2021 Oct 27;7(1):190. doi: 10.1186/s40814-021-00921-0.

    PubMed 34706777

  • Hopstock LA, Deraas TS, Henriksen A, Martiny-Huenger T, Grimsgaard S. Changes in adiposity, physical activity, cardiometabolic risk factors, diet, physical capacity and well-being in inactive women and men aged 57-74 years with obesity and cardiovascular risk - A 6-month complex lifestyle intervention with 6-month follow-up. PLoS One. 2021 Aug 25;16(8):e0256631. doi: 10.1371/journal.pone.0256631. eCollection 2021.

    PubMed 34432850

  • Henriksen A, Sand AS, Deraas T, Grimsgaard S, Hartvigsen G, Hopstock L. Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. BMC Public Health. 2020 Aug 27;20(1):1300. doi: 10.1186/s12889-020-09406-w.

    PubMed 32854671

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle counselling and exercise in people with Cardiovascular Diseases and Lifestyle Risk Reduction, run by University of Tromso at 1 site in Norway.

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 7 inclusion and 0 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: finished, as of the sponsor's last update on 16 Jan 2019. 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 Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline physical activity at 6 months (time frame: 6 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 NCT03807323, which also lists 3 linked publications.

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 16 Jan 2019.

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