Tools for Lasting Lifestyle Changes

Cardiovascular Diseases Clinical Trial

— TLC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807323
• Other study ID #: 2017-1100
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: October 4, 2018

Study information

• Verified date: January 2019
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 4, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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:

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Lifestyle Risk Reduction

Intervention

Behavioral:
• Lifestyle counselling and exercise
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.

Locations

Country	Name	City	State
Norway	UiT the Arctic University of Norway	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
University of Tromso	University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline physical activity at 6 months	Change from baseline steps counted by activity trackers (Polar M430) at 6 months	6 months
Secondary	Change from baseline central obesity at 6 months	Change from baseline waist circumference (cm) at 6 months standardized measured	6 months
Secondary	Change from baseline VO2max at 6 months	Change from baseline VO2max at 6 months measured on treadmill test	6 months