NCT02247219

Brief Summary

The study aims at: Using Intervention mapping as a planning approach for behavior change intervention programs, based on an ecological approach to health and local community and user participation.

  • Explore the behavioral change processes utilizing qualitative methods.
  • Develop theory-based behavior change programs across different domain at healthy living centres.
  • Evaluate the effect of behavior change intervention programs across different domains.
  • Increase health providers' competence in effective behavioral change intervention techniques by networks and education seminars between municipalities and research groups.
  • The programs will specifically target the underlying causes of chronic disease. The investigators will map the distribution of lifestyle habits among individuals and families. The investigators will also explore how lifestyle habits relate to known determinants of social health inequality, such as adverse previous experiences, participation in working life and low income.
  • The investigators also intend to study if socioeconomic differences are of importance for entering or dropping out of HLC interventions, and the ability to sustain lifestyle changes. The investigators will do so by stratified analyses, or by using socioeconomic variables as determinants in effect analyses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

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

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

September 19, 2014

Last Update Submit

May 2, 2018

Conditions

Health Behavior

Keywords

Health educationHealth services research

Outcome Measures

Primary Outcomes (2)

  • Physical activity changes measured with accelerometer

    6 months

  • Dietary changes measured with validated questionnaire

    6 months

Secondary Outcomes (1)

  • Wellbeing, self-rated health and body satisfaction

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

'Counselling and education individually and in groups'

Behavioral: Counselling and education individually and in groups

Waiting list control

OTHER

The waiting list group waits 6 months after assessment and allocation and is reassessed after 6 and 12 months. Both groups are reassessed after 24 months, and the second part of the study is a one group longitudinal cohort study.

Behavioral: Counselling and education individually and in groups

Interventions

Counselling and education individually and in groupsBEHAVIORAL

The counselling method is based om Motivational Interviewing

InterventionWaiting list control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5018, Norway

Location

Related Publications (2)

  • Abildsnes E, Meland E, Mildestvedt T, Stea TH, Berntsen S, Samdal GB. The Norwegian Healthy Life Study: protocol for a pragmatic RCT with longitudinal follow-up on physical activity and diet for adults. BMC Public Health. 2017 Jan 5;17(1):18. doi: 10.1186/s12889-016-3981-1.

    PMID: 28056906DERIVED

  • Stea TH, Haugen T, Berntsen S, Guttormsen V, Overby NC, Haraldstad K, Meland E, Abildsnes E. Using the Intervention Mapping protocol to develop a family-based intervention for improving lifestyle habits among overweight and obese children: study protocol for a quasi-experimental trial. BMC Public Health. 2016 Oct 18;16(1):1092. doi: 10.1186/s12889-016-3766-6.

    PMID: 27756346DERIVED

Related Links

MeSH Terms

Conditions

Health BehaviorHealth Education

Interventions

Counseling

Condition Hierarchy (Ancestors)

BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gro B Samdal, Masters

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor at the Department of Global Publ Health and Prim Care

Study Record Dates

First Submitted

September 19, 2014

First Posted

September 23, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

March 1, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

NO(1)