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Completed

NCT Number: NCT03807323

Tools for Lasting Lifestyle Changes

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Lifestyle Risk Reduction Risk Reduction Behavior

Age range

55 year–75 year

Study type

Interventional

Phase

Not applicable

Primary location

UiT the Arctic University of Norway

Tromsø, 9037, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

Treatment and study plan

Lifestyle counselling and exercise

Behavioral

The program consists of:

  • Instructor-led training twice a week,
  • One individual nutritionist counselling session of followed by three group based two-hour nutritionist counselling focusing on practical food purchase and preparation and
  • 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.

Primary outcomes

  1. Change from baseline physical activity at 6 months

    Time frame: 6 months

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

Secondary outcomes

  1. Change from baseline central obesity at 6 months

    Time frame: 6 months

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

  2. Change from baseline VO2max at 6 months

    Time frame: 6 months

    Change from baseline VO2max at 6 months measured on treadmill test

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • University Hospital of North Norway

Registry information

Official study title

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

Acronym: TLC

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2019
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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