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临床试验/NCT02247219
NCT02247219已完成不适用

Promoting Health in Healthy Living Centres - Does it Work, How Does it Work and Why?

University of Bergen2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
2
主要终点
Physical activity changes measured with accelerometer

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All persons attending a participating Healthy living center who understands norwegian and can answer the questionnaires -

排除标准

  • Do not understand written norwegian language

研究组 & 干预措施

Intervention

Experimental

'Counselling and education individually and in groups'

干预措施: Counselling and education individually and in groups (Behavioral)

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.

干预措施: Counselling and education individually and in groups (Behavioral)

结局指标

主要结局

Physical activity changes measured with accelerometer

时间窗: 6 months

Dietary changes measured with validated questionnaire

时间窗: 6 months

次要结局

  • Wellbeing, self-rated health and body satisfaction(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eivind Meland

Professor at the Department of Global Publ Health and Prim Care

University of Bergen

研究点 (2)

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