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Tools for Lasting Lifestyle Changes (TLC)

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ClinicalTrials.gov Identifier: NCT03807323
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
University Hospital of North Norway
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Lifestyle Risk Reduction Behavioral: Lifestyle counselling and exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 'Lifestyle counselling and exercise' .
The study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' .
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.




Primary Outcome Measures :
  1. Change from baseline physical activity at 6 months [ Time Frame: 6 months ]
    Change from baseline steps counted by activity trackers (Polar M430) at 6 months


Secondary Outcome Measures :
  1. Change from baseline central obesity at 6 months [ Time Frame: 6 months ]
    Change from baseline waist circumference (cm) at 6 months standardized measured

  2. Change from baseline VO2max at 6 months [ Time Frame: 6 months ]
    Change from baseline VO2max at 6 months measured on treadmill test



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807323


Locations
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Norway
UiT the Arctic University of Norway
Tromsø, Norway, 9037
Sponsors and Collaborators
University of Tromso
University Hospital of North Norway
Investigators
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Principal Investigator: Sameline Grimsgaard, MD, MPH, PhD Professor

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Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT03807323     History of Changes
Other Study ID Numbers: 2017-1100
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Tromso:
Primary intervention

Additional relevant MeSH terms:
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Cardiovascular Diseases