Tools for Lasting Lifestyle Changes

NCT ID: NCT03807323

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2018-10-04

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.

Conditions

Cardiovascular Diseases; Lifestyle Risk Reduction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

'Lifestyle counselling and exercise' .

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

Group Type: EXPERIMENTAL

Lifestyle counselling and exercise

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack:

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sameline Grimsgaard, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

UiT the Arctic University of Norway

Tromsø, , Norway

Countries

Norway

References

Deraas TS, Hopstock L, Henriksen A, Morseth B, Sand AS, Njolstad I, Pedersen S, Sagelv E, Johansson J, Grimsgaard S. Complex lifestyle intervention among inactive older adults with elevated cardiovascular disease risk and obesity: a mixed-method, single-arm feasibility study for RESTART-a randomized controlled trial. Pilot Feasibility Stud. 2021 Oct 27;7(1):190. doi: 10.1186/s40814-021-00921-0.

Reference Type: DERIVED

PMID: 34706777 (View on PubMed)

Hopstock LA, Deraas TS, Henriksen A, Martiny-Huenger T, Grimsgaard S. Changes in adiposity, physical activity, cardiometabolic risk factors, diet, physical capacity and well-being in inactive women and men aged 57-74 years with obesity and cardiovascular risk - A 6-month complex lifestyle intervention with 6-month follow-up. PLoS One. 2021 Aug 25;16(8):e0256631. doi: 10.1371/journal.pone.0256631. eCollection 2021.

Reference Type: DERIVED

PMID: 34432850 (View on PubMed)

Henriksen A, Sand AS, Deraas T, Grimsgaard S, Hartvigsen G, Hopstock L. Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. BMC Public Health. 2020 Aug 27;20(1):1300. doi: 10.1186/s12889-020-09406-w.

Reference Type: DERIVED

PMID: 32854671 (View on PubMed)

Other Identifiers

2017-1100

Identifier Type: -

Identifier Source: org_study_id