Promoting Health in Healthy Living Centres - a Clinical Study Among Adults
Condition: Health Behavior
Study type: Interventional

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.
    

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.
    

Intervention name(s): Counselling and education individually and in groups
Intervention type(s): Behavioral
Intervention description(s): The counselling method is based om Motivational Interviewing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Health education; Health services research