Tools for Lasting Lifestyle Changes (TLC)

University of Tromso (UiT)

Status: Completed

Conditions: Lifestyle Risk Reduction; Cardiovascular Diseases

Treatments: Behavioral: Lifestyle counselling and exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03807323

2017-1100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Age 55-74 years
2. BMI> 30
3. Moderate elevated NORRISK 2 score
4. Motivation for lifestyle change
5. 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:

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

'Lifestyle counselling and exercise' .

Experimental group

Description:

The study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' .

Treatment:

Behavioral: Lifestyle counselling and exercise