Tools for Lasting Lifestyle Changes

University of Tromso16 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cardiovascular Diseases Lifestyle Risk Reduction

Interventions

Lifestyle counselling and exerciseBEHAVIORAL

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.

Eligibility

Min age: 55 YearsMax age: 75 Years

Medical Language ↔ Plain English

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:

Locations (1)

UiT the Arctic University of Norway

Tromsø, Norway

Outcomes

Primary Outcomes

Change from baseline physical activity at 6 months

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

Time frame: 6 months

Secondary Outcomes

Change from baseline central obesity at 6 months

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

Time frame: 6 months

Change from baseline VO2max at 6 months

Change from baseline VO2max at 6 months measured on treadmill test

Time frame: 6 months

Data from ClinicalTrials.gov

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