<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02247219</url>
  </required_header>
  <id_info>
    <org_study_id>228454/DHE</org_study_id>
    <nct_id>NCT02247219</nct_id>
  </id_info>
  <brief_title>Promoting Health in Healthy Living Centres - a Clinical Study Among Adults</brief_title>
  <official_title>Promoting Health in Healthy Living Centres - Does it Work, How Does it Work and Why?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Agder</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bergen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims at:&#xD;
&#xD;
      Using Intervention mapping as a planning approach for behavior change intervention programs,&#xD;
      based on an ecological approach to health and local community and user participation.&#xD;
&#xD;
        -  Explore the behavioral change processes utilizing qualitative methods.&#xD;
&#xD;
        -  Develop theory-based behavior change programs across different domain at healthy living&#xD;
           centres.&#xD;
&#xD;
        -  Evaluate the effect of behavior change intervention programs across different domains.&#xD;
&#xD;
        -  Increase health providers' competence in effective behavioral change intervention&#xD;
           techniques by networks and education seminars between municipalities and research&#xD;
           groups.&#xD;
&#xD;
        -  The programs will specifically target the underlying causes of chronic disease. The&#xD;
           investigators will map the distribution of lifestyle habits among individuals and&#xD;
           families. The investigators will also explore how lifestyle habits relate to known&#xD;
           determinants of social health inequality, such as adverse previous experiences,&#xD;
           participation in working life and low income.&#xD;
&#xD;
        -  The investigators also intend to study if socioeconomic differences are of importance&#xD;
           for entering or dropping out of HLC interventions, and the ability to sustain lifestyle&#xD;
           changes. The investigators will do so by stratified analyses, or by using socioeconomic&#xD;
           variables as determinants in effect analyses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approaches, hypotheses and choice of method&#xD;
&#xD;
      A multidisciplinary team of researchers will work to realize this project according to a&#xD;
      systematic stepwise approach that combines the use of the PRECEDE-PROCEED model and&#xD;
      Intervention Mapping (IM) protocol. The PRECEDE-PROCEED model is a conceptual model serving&#xD;
      the needs of the current project with an educational and ecological approach in health&#xD;
      program planning. IM will be used as a planning approach to develop theory- and evidence&#xD;
      based health promoting intervention programs. Following the IM process, it maps the path from&#xD;
      needs assessment, development of program objectives, selection of intervention methods and&#xD;
      strategies, and program design. A benefit of IM is its linkage with community-based&#xD;
      participatory research as it includes engagement of community members to identify and refine&#xD;
      priority areas. Thus, the process of including IM in developing intervention programs will&#xD;
      secure that users and staff in the healthy living centres will have significant autonomy and&#xD;
      may influence the development of the intervention programme, and tailor the intervention to&#xD;
      fit local needs.&#xD;
&#xD;
      In the initial steps of the IM process will explore the research field utilizing qualitative&#xD;
      research methods. The investigators will use focus groups and in-depth interviews to obtain&#xD;
      sufficient information to tailor the intervention to local needs and resources. The&#xD;
      investigators intend to explore the expectations staff and users of HLCs have about the&#xD;
      different intervention programmes, and how they perceive attendance.&#xD;
&#xD;
      The research program will have Self Determination Theory (SDT) as a theoretical point of&#xD;
      departure and as an overall theoretical framework for qualitative studies and RCTs of&#xD;
      behavioral intervention programs across different behavioural domains. Even though our logic&#xD;
      model for understanding behavioral change is linear, focusing on the presumed cause-effect&#xD;
      identified in theory and empirical research, the investigators acknowledge that the&#xD;
      behavioral treatment programs and proposed outcomes are part of a complex multilevel system&#xD;
      (an ecological approach) (Bartholomew et al.2011). An ecological way of analyzing health&#xD;
      problems and solutions support the use of a variety of theories when developing a program, as&#xD;
      opposed to one single theory. Theories can help in describing the at-risk groups and&#xD;
      environmental agents, understand the health-promotion behaviors and environmental agents,&#xD;
      understanding the heath-promotion behaviors, and finding methods to promote change&#xD;
      (Bartholomew, 2011).&#xD;
&#xD;
      The 0-hypothesis in the controlled studies is that the different behavioral treatment&#xD;
      programs have no effects compared with controls. Alternative research hypotheses are:&#xD;
&#xD;
        -  Participants who perceive the interpersonal health care-climate as autonomy supportive,&#xD;
           will report more autonomous reasons for attending the program and following it's&#xD;
           guidelines (self-determined).&#xD;
&#xD;
        -  The program will predict increases in autonomous motivation for behavioral change,&#xD;
           perceived self-efficacy for program constructs: e.g. physical exercise, healthy eating,&#xD;
           and quality of life.&#xD;
&#xD;
        -  The program will improve the participants' health behavior.&#xD;
&#xD;
        -  The program will improve the participants' self-perceived health and risk factors of&#xD;
           non-communicable diseases.&#xD;
&#xD;
      The investigators will also measure effects on health behaviour and health in ordinary&#xD;
      practice in the municipalities, in studying effects of systemic and organisational&#xD;
      interventions. This will benefit the external validity of the research project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity changes measured with accelerometer</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary changes measured with validated questionnaire</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wellbeing, self-rated health and body satisfaction</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>'Counselling and education individually and in groups'</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counselling and education individually and in groups</intervention_name>
    <description>The counselling method is based om Motivational Interviewing</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Waiting list control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: All persons attending a participating Healthy living center who&#xD;
        understands norwegian and can answer the questionnaires -&#xD;
&#xD;
        Exclusion Criteria: Do not understand written norwegian language&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gro B Samdal, Masters</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Bergen</name>
      <address>
        <city>Bergen</city>
        <state>Hordaland</state>
        <zip>5018</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://www.uib.no/personer/Eivind.Meland</url>
    <description>Home page of principal investigator</description>
  </link>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bergen</investigator_affiliation>
    <investigator_full_name>Eivind Meland</investigator_full_name>
    <investigator_title>Professor at the Department of Global Publ Health and Prim Care</investigator_title>
  </responsible_party>
  <keyword>Health education</keyword>
  <keyword>Health services research</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We will share data with faculty members at UoB and UoA based on agreements of analysing and Publishing.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02247219
org study id: 228454/DHE
nct id: NCT02247219
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Physical activity changes measured with accelerometer
time frame: 6 months
measure: Dietary changes measured with validated questionnaire
time frame: 6 months
measure: Wellbeing, self-rated health and body satisfaction
time frame: 6 months
arm group label: Intervention
arm group type: Experimental
description: 'Counselling and education individually and in groups'
arm group label: Waiting list control
arm group type: Other
description: 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.
intervention type: Behavioral
intervention name: Counselling and education individually and in groups
description: The counselling method is based om Motivational Interviewing
arm group label: Intervention
arm group label: Waiting list control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gro B Samdal, Masters
role: Principal Investigator
affiliation: University of Bergen
facility: 
country: Norway
url: http://www.uib.no/personer/Eivind.Meland
description: Home page of principal investigator
responsible party type: Principal Investigator
investigator affiliation: University of Bergen
investigator full name: Eivind Meland
investigator title: Professor at the Department of Global Publ Health and Prim Care
sharing ipd: Undecided
ipd description: We will share data with faculty members at UoB and UoA based on agreements of analysing and Publishing.