Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01194518
Recruitment Status : Unknown
Verified September 2010 by National Cheng Kung University.
Recruitment status was:  Active, not recruiting
First Posted : September 3, 2010
Last Update Posted : September 17, 2010
National Cheng-Kung University Hospital
E-DA Hospital
Information provided by:
National Cheng Kung University

Brief Summary:
The lifestyle consulting program through one year follow-up could effective increase the scores of health responsibility and nutrition according to the past three-year study. Behavior change is a dynamic and complex process. Using a long-term follow up approach will be able to understand the trajectory of behavior change. The purpose of this study is to explore life experience and lifestyle intervention program for patients with chronic kidney disease using mixed methods with a longitudinal approach. The first year of this study will include a qualitative study with in depth interview of the subjects who attend previous study in the research team and have the scores of health promoting lifestyle among the highest 27% and lowest 27%. The life experience will be explored. The quantitative study will be an experimental design. Qualified subjects will be randomly assigned to intervention or control group. The intervention protocol is based on trans-theoretical model. Each subject will be followed every six months. The second and third year of studies will continue to use the qualitative and quantitative approach to understand the life experience and meaning among patients with chronic kidney diseases. The trajectory of life experience and life style changes will be explored. The method may strengthen the effectiveness of lifestyle program and may provide comprehensive understanding of the trajectory of behavior changes among patient with chronic kidney disease.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: Lifestyle Intervention Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: Exploring Life Experience and Lifestyle Intervention Program Among Patients
Study Start Date : August 2010
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lifestyle Intervention Program Behavioral: Lifestyle Intervention Program

Primary Outcome Measures :
  1. Body weight [ Time Frame: six months ]
  2. Waist to hip ratio [ Time Frame: six months ]
  3. Overall knowledge of renal protection [ Time Frame: six months ]
    The 20 item Renal Protection Knowledge Checklist was developed by researchers will use to measure three dimensions of knowledge: renal function protection, use of Chinese herbs and diet.

  4. Health promotion lifestyle [ Time Frame: six months ]
    Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).

  5. Quality of Life [ Time Frame: six months ]
    The study will use WHOQOL-BREF to measure the outcome.

  6. Physical activity [ Time Frame: six months ]
    The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.

  7. General Health Perceptions [ Time Frame: six months ]
    The study will use General Health Perceptions Subscale of SF-36 Health Status Scale to measure the outcome.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Clinical diagnosis of Early Stages of Chronic Kidney Disease (GFR≧30ml/min/1.73㎡)
  • Must be able to commmunicate in Chinese or Taiwanese
  • Muse be voluntarily to attend
  • Patient who does not exercise regularly
  • Patient whose blood pressure higher than 140/90 mmHg
  • Patient who is overweight or BMI>25kg/㎡

Exclusion Criteria:

  • Patient who limited to exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01194518

National Cheng Kung University
Tainan City, Taiwan
Sponsors and Collaborators
National Cheng Kung University
National Cheng-Kung University Hospital
E-DA Hospital

Responsible Party: Miaofen Yen, National Cheng Kung University Identifier: NCT01194518     History of Changes
Other Study ID Numbers: NSC992314B006048MY3
First Posted: September 3, 2010    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: September 2010

Keywords provided by National Cheng Kung University:
Life experience
Life style
Health behavior
Mixed method

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency