Health BehaviorNCT02247219
Promoting Health in Healthy Living Centres - a Clinical Study Among Adults
A study testing Counselling and education individually and in groups in people with Health Behavior, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Counselling and education individually and in groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: All persons attending a participating Healthy living center who understands norwegian and can answer the questionnaires -
Exclusion Criteria: Do not understand written norwegian language
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Health in Healthy Living Centres - Does it Work, How Does it Work and Why?
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.
Read the detailed description
Approaches, hypotheses and choice of method
A multidisciplinary team of researchers will work to realize this project according to a systematic stepwise approach that combines the use of the PRECEDE-PROCEED model and Intervention Mapping (IM) protocol. The PRECEDE-PROCEED model is a conceptual model serving the needs of the current project with an educational and ecological approach in health program planning. IM will be used as a planning approach to develop theory- and evidence based health promoting intervention programs. Following the IM process, it maps the path from needs assessment, development of program objectives, selection of intervention methods and strategies, and program design. A benefit of IM is its linkage with community-based participatory research as it includes engagement of community members to identify and refine priority areas. Thus, the process of including IM in developing intervention programs will secure that users and staff in the healthy living centres will have significant autonomy and may influence the development of the intervention programme, and tailor the intervention to fit local needs.
In the initial steps of the IM process will explore the research field utilizing qualitative research methods. The investigators will use focus groups and in-depth interviews to obtain sufficient information to tailor the intervention to local needs and resources. The investigators intend to explore the expectations staff and users of HLCs have about the different intervention programmes, and how they perceive attendance.
The research program will have Self Determination Theory (SDT) as a theoretical point of departure and as an overall theoretical framework for qualitative studies and RCTs of behavioral intervention programs across different behavioural domains. Even though our logic model for understanding behavioral change is linear, focusing on the presumed cause-effect identified in theory and empirical research, the investigators acknowledge that the behavioral treatment programs and proposed outcomes are part of a complex multilevel system (an ecological approach) (Bartholomew et al.2011). An ecological way of analyzing health problems and solutions support the use of a variety of theories when developing a program, as opposed to one single theory. Theories can help in describing the at-risk groups and environmental agents, understand the health-promotion behaviors and environmental agents, understanding the heath-promotion behaviors, and finding methods to promote change (Bartholomew, 2011).
The 0-hypothesis in the controlled studies is that the different behavioral treatment programs have no effects compared with controls. Alternative research hypotheses are:
- Participants who perceive the interpersonal health care-climate as autonomy supportive, will report more autonomous reasons for attending the program and following it's guidelines (self-determined).
- The program will predict increases in autonomous motivation for behavioral change, perceived self-efficacy for program constructs: e.g. physical exercise, healthy eating, and quality of life.
- The program will improve the participants' health behavior.
- The program will improve the participants' self-perceived health and risk factors of non-communicable diseases.
The investigators will also measure effects on health behaviour and health in ordinary practice in the municipalities, in studying effects of systemic and organisational interventions. This will benefit the external validity of the research project.
- Conditions
- Health Behavior
- Being tested
- Counselling and education individually and in groups
- Keywords
- Health education, Health services research
- Medical subject headings
- Health Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling and education individually and in groupsBehavioural
The counselling method is based om Motivational Interviewing
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 'Counselling and education individually and in groups' Receives: 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. Receives: Behavioral: Counselling and education individually and in groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity changes measured with accelerometer
Measured: 6 months
Dietary changes measured with validated questionnaire
Measured: 6 months
Secondary outcomes (1)
Wellbeing, self-rated health and body satisfaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Agder
- Responsible party
- Principal investigator, Eivind Meland, University of Bergen
- Investigators
- Gro B Samdal, Masters, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247219
- Sponsor's protocol ID
- 228454/DHE
- Status last verified
- May 2018
- First submitted
- 19 Sep 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: We will share data with faculty members at UoB and UoA based on agreements of analysing and Publishing.
Publications
Iglebaek MS, Espeland J, Meland E, Mildestvedt T. Self-reported physical activity in a randomized study from Norwegian Healthy Life Centres. Prim Health Care Res Dev. 2026 Sep 11;27:e100. doi: 10.1017/S1463423626101686.
PubMed 42723291Abildsnes 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.
PubMed 28056906Stea 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.
PubMed 27756346
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Health in Healthy Living Centres - Does it Work, How Does it Work and Why?
- ClinicalTrials.gov ID
- NCT02247219
- Acronym / sponsor ID
- 228454/DHE
- Conditions
- Health Behavior
- Keywords
- Health education, Health services research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- University of Agder
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approaches, hypotheses and choice of method
A multidisciplinary team of researchers will work to realize this project according to a systematic stepwise approach that combines the use of the PRECEDE-PROCEED model and Intervention Mapping (IM) protocol. The PRECEDE-PROCEED model is a conceptual model serving the needs of the current project with an educational and ecological approach in health program planning. IM will be used as a planning approach to develop theory- and evidence based health promoting intervention programs. Following the IM process, it maps the path from needs assessment, development of program objectives, selection of intervention methods and strategies, and program design. A benefit of IM is its linkage with community-based participatory research as it includes engagement of community members to identify and refine priority areas. Thus, the process of including IM in developing intervention programs will secure that users and staff in the healthy living centres will have significant autonomy and may influence the development of the intervention programme, and tailor the intervention to fit local needs.
In the initial steps of the IM process will explore the research field utilizing qualitative research methods. The investigators will use focus groups and in-depth interviews to obtain sufficient information to tailor the intervention to local needs and resources. The investigators intend to explore the expectations staff and users of HLCs have about the different intervention programmes, and how they perceive attendance.
The research program will have Self Determination Theory (SDT) as a theoretical point of departure and as an overall theoretical framework for qualitative studies and RCTs of behavioral intervention programs across different behavioural domains. Even though our logic model for understanding behavioral change is linear, focusing on the presumed cause-effect identified in theory and empirical research, the investigators acknowledge that the behavioral treatment programs and proposed outcomes are part of a complex multilevel system (an ecological approach) (Bartholomew et al.2011). An ecological way of analyzing health problems and solutions support the use of a variety of theories when developing a program, as opposed to one single theory. Theories can help in describing the at-risk groups and environmental agents, understand the health-promotion behaviors and environmental agents, understanding the heath-promotion behaviors, and finding methods to promote change (Bartholomew, 2011).
The 0-hypothesis in the controlled studies is that the different behavioral treatment programs have no effects compared with controls. Alternative research hypotheses are:
- Participants who perceive the interpersonal health care-climate as autonomy supportive, will report more autonomous reasons for attending the program and following it's guidelines (self-determined).
- The program will predict increases in autonomous motivation for behavioral change, perceived self-efficacy for program constructs: e.g. physical exercise, healthy eating, and quality of life.
- The program will improve the participants' health behavior.
- The program will improve the participants' self-perceived health and risk factors of non-communicable diseases.
The investigators will also measure effects on health behaviour and health in ordinary practice in the municipalities, in studying effects of systemic and organisational interventions. This will benefit the external validity of the research project.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Counselling and education individually and in groups'Counselling and education individually and in groups' |
| Waiting list control | Other | Behavioral: Counselling and education individually and in groupsThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counselling and education individually and in groupsThe counselling method is based om Motivational Interviewing | Behavioural | Intervention, Waiting list control |
Primary outcome
Physical activity changes measured with accelerometer
Time frame: 6 months
Dietary changes measured with validated questionnaire
Time frame: 6 months
1 secondary outcome
Wellbeing, self-rated health and body satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 42723291Iglebaek MS, Espeland J, Meland E, Mildestvedt T. Self-reported physical activity in a randomized study from Norwegian Healthy Life Centres. Prim Health Care Res Dev. 2026 Sep 11;27:e100. doi: 10.1017/S1463423626101686.
- Derived from this study: PubMed 28056906Abildsnes 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.
- Derived from this study: PubMed 27756346Stea 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.
- Home page of principal investigatorLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We will share data with faculty members at UoB and UoA based on agreements of analysing and Publishing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gro B Samdal, Masters principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling and education individually and in groups in people with Health Behavior, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity changes measured with accelerometer (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02247219, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.