Tools for Lasting Lifestyle Changes

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Lifestyle Risk Reduction
• Interventions: Behavioral: Lifestyle counselling and exercise

• Registration Number: NCT03807323
• Lead Sponsor: University of Tromso

Brief 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.

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.

Study Timeline

• Study Start: 2017-09-25
• Primary Completion: 2018-10-04
• Study Completion: 2018-10-04
• Study First Submitted: 2018-11-16
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-14
• Last Update Submitted: 2019-01-14
• Study First Posted: 2019-01-16
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 16

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:

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline physical activity at 6 months	6 months	Change from baseline steps counted by activity trackers (Polar M430) at 6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline central obesity at 6 months	6 months	Change from baseline waist circumference (cm) at 6 months standardized measured
Change from baseline VO2max at 6 months	6 months	Change from baseline VO2max at 6 months measured on treadmill test

Trial Locations

Locations (1)

UiT the Arctic University of Norway; 🇳🇴 Tromsø, Norway