NCT03807323

Tools for Lasting Lifestyle Changes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Tromso · Academic / Other
• Sex: —
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Lifestyle Risk Reduction

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle counselling and exercise	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.

Timeline

• Start date: 2017-09-25
• Primary completion: 2018-10-04
• Completion: 2018-10-04
• First posted: 2019-01-16
• Last updated: 2019-01-16

Locations

1 site across 1 country: Norway