NCT01194518

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 17, 2010

Status Verified

September 1, 2010

Enrollment Period

2.9 years

First QC Date

August 31, 2010

Last Update Submit

September 16, 2010

Conditions

Chronic Kidney Disease

Keywords

Life experienceLife styleHealth behaviorMixed method

Outcome Measures

Primary Outcomes (7)

  • Body weight

    six months

  • Waist to hip ratio

    six months

  • Overall knowledge of renal protection

    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.

    six months

  • Health promotion lifestyle

    Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).

    six months

  • Quality of Life

    The study will use WHOQOL-BREF to measure the outcome.

    six months

  • Physical activity

    The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.

    six months

  • General Health Perceptions

    The study will use General Health Perceptions Subscale of SF-36 Health Status Scale to measure the outcome.

    six months

Study Arms (1)

Lifestyle Intervention Program

EXPERIMENTAL
Behavioral: Lifestyle Intervention Program

Interventions

Lifestyle Intervention ProgramBEHAVIORAL
Lifestyle Intervention Program

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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/㎡

You may not qualify if:

  • Patient who limited to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHealth Behavior

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 3, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 17, 2010

Record last verified: 2010-09

Locations

TW(1)