NCT03807323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

November 16, 2018

Last Update Submit

January 14, 2019

Conditions

Cardiovascular DiseasesLifestyle Risk Reduction

Keywords

Primary intervention

Outcome Measures

Primary Outcomes (1)

  • Change from baseline physical activity at 6 months

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

    6 months

Secondary Outcomes (2)

  • Change from baseline central obesity at 6 months

    6 months

  • Change from baseline VO2max at 6 months

    6 months

Study Arms (1)

'Lifestyle counselling and exercise' .

EXPERIMENTAL

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

Behavioral: Lifestyle counselling and exercise

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.

'Lifestyle counselling and exercise' .

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55-74 years
  • BMI\> 30
  • Moderate elevated NORRISK 2 score
  • Motivation for lifestyle change
  • Has agreed to attend and participate in a student study during the study period

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UiT the Arctic University of Norway

Tromsø, 9037, Norway

Location

Related Publications (3)

  • 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.

    PMID: 34706777DERIVED

  • 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.

    PMID: 34432850DERIVED

  • 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.

    PMID: 32854671DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesRisk Reduction Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sameline Grimsgaard, MD, MPH, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

January 16, 2019

Study Start

September 25, 2017

Primary Completion

October 4, 2018

Study Completion

October 4, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)