Chronic Kidney DiseasesNCT01194518

Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD

A study testing Lifestyle counseling Program in people with Chronic Kidney Diseases and Health Behaviors, run by National Cheng Kung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

to compare the effectiveness of tailored TTM-based interventions (intervention group) compared to usual care (control group) on biomarkers of kidney function, physical indicators, adoption of health-promoting lifestyle behaviors, kidney disease knowledge, perceived self-efficacy, perceived benefits and barriers to… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Chronic Kidney Diseases, Health Behaviors, Patient Education
What is being tested?: Lifestyle counseling Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteTaiwan
Study dates: Aug 2010to Oct 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1.at least 20 years old 2. diagnosed as stage 1-3 CKD (eGFR greater than ≧ 44 ml/min per 1.73 m2), 3. spoke Mandarin, 4.could be followed up every 6 months when they returned for a clinic outpatient visit.
-

Who cannot join

could not participate in moderate exercise
not able to verbalize understanding of the study
already enrolled in another program.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Cheng Kung University
Tainan, 70101

Other trials in Taiwan

About this study

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

Read the detailed description

A thirty-month clinical trial (ClinicalTrials.gov registration NCT01194518) was conducted from October 2010 through October 2013. The CONSORT checklist (Schulz et al., 2010) guided the study. Data were collected at baseline and at 6, 12, 18, 24, and 30 months post-intervention.

Participants and Setting After obtaining approval to conduct the study from the Institutional Review Board, the nephrology case managers from the outpatient clinics of two medical centers in southern Taiwan were contacted and asked to refer patients to the study. Participants were included if they were at least 20 years old, diagnosed with stages 1 to 3 CKD, spoke Mandarin, and could be followed up every 6 months when they returned for an outpatient visit. Patients who were unable to participate in moderate exercise, unable to verbalize that they understood the study, or were already enrolled in another program were excluded. Upon obtaining written informed consent subjects were randomly assigned to the control or intervention group at a ratio of 1 to 1 using paper ballots.

The Bureau of National Health Insurance (BNHI) in Taiwan launched the CKD care program for pre-ESRD care which suggested that CKD management and education depended on the stage of CKD (Chen et al., 2011). In addition, Taiwan established a medical system protocol to standardize and regulate pre-ESRD care with all medical expenditures covered by the National Health Insurance (NHI). Therefore, patients receive regular follow-ups as nephrology outpatients with the nephrology case managers providing usual care.

Conditions: Chronic Kidney Diseases, Health Behaviors, Patient Education
Being tested: Lifestyle counseling Program
Keywords: Chronic kidney disease, health-promoting, randomized controlled trial, tailored intervention, transtheoretical model
Medical subject headings: Renal Insufficiency, Chronic, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lifestyle counseling ProgramBehavioural
Also called tailored interventions
The tailored intervention made use of the 10 processes of change, important guides for developing intervention programs, which have received the most empirical support to date. The 10 processes include consciousness raising, dramatic relief, self-reevaluation, environmental reevaluation, self-liberation, social liberation, counterconditioning, stimulus control, reinforcement management, and helping relations. The different tailored interventions were based on the processes of change matched to the patient's stage of change, providing strategies that may be especially helpful to patients. According to the Lenio analysis of the TTM model of behavior change, the first five processes are used in the early stages, and the last five are used in the later stages.

Study groups in NCT01194518
Study group	Role	What they receive
Intervention group	Experimental	Intervention groups completed the stage-of-change and readiness-to-change assessments. Intervention groups were provided tailored interventions based on the premise that patient response to physical activity in stages for lifestyle counseling from baseline, 6, 12,18 24, and 30 months. Receives: Behavioral: Lifestyle counseling Program
Control group	No intervention	Control group only received usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
The eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) formula (eGFR (ml/min/1.73 m2) = 186 × (SCr)-1.154 × (Age)-0.203 × (0.742 if female) (National Kidney Foundation, 2002).
The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Measured: The baseline and at 6, 12, 18, 24, and 30 months post intervention
The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
Waist circumference in centimeters was measured at the level midway between the lowest rib margin and the iliac crest at baseline, 6, 12, 18, 24, and 30 months for each intervention.
The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Measured: The baseline and at 6, 12, 18, 24, and 30 months post intervention
The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
Hip circumference was measured at the widest area over the trochanters at 6, 12, 18, 24, and 30 months of every intervention.
The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Measured: The baseline and at 6, 12, 18, 24, and 30 months post intervention
The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
The HPLP-II is validated, Self-report questionnaires Health promotion lifestyle was measured by the 52-item Health-Promoting Lifestyle-II (HPLP-II) Chinese questionnaire. The total scores of the HPLP-II are determined by calculating a mean item response. The HPLP-II uses mean sums of scale items to remain the 1 to 4 metric of item. Higher scores indicated better health-promoting lifestyle behaviors.
The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Measured: The baseline and at 6, 12, 18, 24, and 30 months post intervention
The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
The renal protection checklist (RPK) is validated, Self-report questionnaires a disease-specific knowledge of renal protection checklist were developed by Yen, Huang, and Teng in 2008. The checklist consists of 20 items including three domains: renal function protection (11 items), knowledge of Chinese herbal medicine related to renal function (5 items), and diet with CKD (4 items). Item responses were "true" or "false." Each item is scored with 5 points for each correct answer. The total scores for the checklist range from 0-100. Higher scores indicate higher knowledge of renal function protection.
The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Measured: The baseline and at 6, 12, 18, 24, and 30 months post intervention
The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four.
The results presented the physical health QOL scores at each time point from baseline to 12, and 24 months.
Measured: The baseline and at 12, 24 months post intervention
The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four.
The results present the psychological health QOL scores from baseline to 12, and 24 Months.
Measured: The baseline and at 12, 24 months post intervention
The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months.
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four.
The results present the Social Relationships QOL scores at each time point from baseline to 12, and 24 months.
Measured: The baseline and at 12, 24 months post intervention
The Results of Environment QOL Scores From Baseline to 12, and 24 Months
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four.
The results present the Environment QOL scores at each time point from baseline to 12, 24 months.
Measured: The baseline and at 12, 24 months post intervention
The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months
The Perceived self-efficacy of physical activity is validated, and the Self-report questionnaire.
The perceived self-efficacy scale was used to measure perceived self-efficacy for physical activity. Fifteen items are answered on a six-point Likert scale ranging from 1 (completely uncertain) to 6 (completely certain). The total score ranges from 15-90, with a higher score representing greater perceived self-efficacy for physical activity.
The results present the Perceived self-efficacy of physical activity scores at each time point from baseline to 12, and 24 months.
Measured: The baseline and at 12, 24 months post intervention
The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months
The Decisional Balance Scale measures the perceived benefits and barriers of physical activity on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The scale of the benefits of changing physical activity behaviors (14 items) and the total score range from 14-84. The higher the scores represent the perceived benefits of physical activity is higher.
The results present the Decisional balance (perceived benefits of physical activity) scores at each time point from baseline to 12, and 24 months.
Measured: The baseline and at 12, 24 months post intervention
The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months
The Decisional Balance Scale measures the perceived benefits and barriers of physical activity on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The scale of the barrier of changing physical activity behaviors (15 items) and the total score range from 15-90. The higher the scores represent the perceived barrier to physical activity is higher.
The results present the Decisional Balance (Perceived Barrier of Physical Activity) scores at each time point from baseline to 12, and 24 months.
Measured: The baseline and at 12, 24 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Oct 2013

First posted3 Sep 2010 (estimated)
Study startAug 2010
Primary completionJul 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01194518
Sponsor's protocol ID: NSC992314B006048MY3
Status last verified: Jan 2023
First submitted: 31 Aug 2010
Last updated: 28 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: De-identified individuals participants data for all primary and secondary outcome measures.

Publications

Araujo-Soares V, Hankonen N, Presseau J, Rodrigues A, Sniehotta FF. Developing Behavior Change Interventions for Self-Management in Chronic Illness: An Integrative Overview. Eur Psychol. 2019;24(1):7-25. doi: 10.1027/1016-9040/a000330. Epub 2018 Aug 16.
PubMed 31496632
Barzin M, Hosseinpanah F, Serahati S, Salehpour M, Nassiri AA, Azizi F. Changes in waist circumference and incidence of chronic kidney disease. Eur J Clin Invest. 2014 May;44(5):470-6. doi: 10.1111/eci.12253.
PubMed 24580088
Chang PY, Chien LN, Lin YF, Wu MS, Chiu WT, Chiou HY. Risk factors of gender for renal progression in patients with early chronic kidney disease. Medicine (Baltimore). 2016 Jul;95(30):e4203. doi: 10.1097/MD.0000000000004203.
PubMed 27472690
Chen YC, Lai SH, Tsai YW, Chang SS. Visceral Adiposity Index as a Predictor of Chronic Kidney Disease in a Relatively Healthy Population in Taiwan. J Ren Nutr. 2018 Mar;28(2):91-100. doi: 10.1053/j.jrn.2017.07.006. Epub 2017 Nov 14.
PubMed 29146142
Chen SH, Tsai YF, Sun CY, Wu IW, Lee CC, Wu MS. The impact of self-management support on the progression of chronic kidney disease--a prospective randomized controlled trial. Nephrol Dial Transplant. 2011 Nov;26(11):3560-6. doi: 10.1093/ndt/gfr047. Epub 2011 Mar 17.
PubMed 21414969
Coresh J, Turin TC, Matsushita K, Sang Y, Ballew SH, Appel LJ, Arima H, Chadban SJ, Cirillo M, Djurdjev O, Green JA, Heine GH, Inker LA, Irie F, Ishani A, Ix JH, Kovesdy CP, Marks A, Ohkubo T, Shalev V, Shankar A, Wen CP, de Jong PE, Iseki K, Stengel B, Gansevoort RT, Levey AS; New Collective Author. Decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality. JAMA. 2014 Jun 25;311(24):2518-2531. doi: 10.1001/jama.2014.6634.
PubMed 24892770
Fischer F, Lange K, Klose K, Greiner W, Kraemer A. Barriers and Strategies in Guideline Implementation-A Scoping Review. Healthcare (Basel). 2016 Jun 29;4(3):36. doi: 10.3390/healthcare4030036.
PubMed 27417624
Fung E, Kurella Tamura M. Epidemiology and Public Health Concerns of CKD in Older Adults. Adv Chronic Kidney Dis. 2016 Jan;23(1):8-11. doi: 10.1053/j.ackd.2015.10.001.
PubMed 26709057
GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
PubMed 32061315
Hsu CC, Hwang SJ, Wen CP, Chang HY, Chen T, Shiu RS, Horng SS, Chang YK, Yang WC. High prevalence and low awareness of CKD in Taiwan: a study on the relationship between serum creatinine and awareness from a nationally representative survey. Am J Kidney Dis. 2006 Nov;48(5):727-38. doi: 10.1053/j.ajkd.2006.07.018.
PubMed 17059992
Jha V, Modi GK. Getting to know the enemy better-the global burden of chronic kidney disease. Kidney Int. 2018 Sep;94(3):462-464. doi: 10.1016/j.kint.2018.05.009. Epub 2018 Aug 3.
PubMed 30078513
Lee MC, Wu SV, Hsieh NC, Tsai JM. Self-Management Programs on eGFR, Depression, and Quality of Life among Patients with Chronic Kidney Disease: A Meta-Analysis. Asian Nurs Res (Korean Soc Nurs Sci). 2016 Dec;10(4):255-262. doi: 10.1016/j.anr.2016.04.002. Epub 2016 May 13.
PubMed 28057311
Lopez-Vargas PA, Tong A, Howell M, Craig JC. Educational Interventions for Patients With CKD: A Systematic Review. Am J Kidney Dis. 2016 Sep;68(3):353-70. doi: 10.1053/j.ajkd.2016.01.022. Epub 2016 Mar 26.
PubMed 27020884
Luyckx VA, Tuttle KR, Garcia-Garcia G, Gharbi MB, Heerspink HJL, Johnson DW, Liu ZH, Massy ZA, Moe O, Nelson RG, Sola L, Wheeler DC, White SL. Reducing major risk factors for chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):71-87. doi: 10.1016/j.kisu.2017.07.003. Epub 2017 Sep 20.
PubMed 30675422
McCoy CE. Understanding the Intention-to-treat Principle in Randomized Controlled Trials. West J Emerg Med. 2017 Oct;18(6):1075-1078. doi: 10.5811/westjem.2017.8.35985. Epub 2017 Sep 18.
PubMed 29085540

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study
ClinicalTrials.gov ID: NCT01194518
Acronym / sponsor ID: NSC992314B006048MY3
Conditions: Chronic Kidney Diseases, Health Behaviors, Patient Education
Keywords: Chronic kidney disease, health-promoting, randomized controlled trial, tailored intervention, transtheoretical model
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: National Cheng Kung UniversityUniversity, hospital or other
Collaborators: National Cheng-Kung University Hospital, E-DA Hospital
Study start: Aug 2010
Primary completion: Jul 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 3 Sep 2010 (estimated)
Results: Posted 28 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intervention group	Experimental	Behavioral: Lifestyle counseling ProgramIntervention groups completed the stage-of-change and readiness-to-change assessments. Intervention groups were provided tailored interventions based on the premise that patient response to physical activity in stages for lifestyle counseling from baseline, 6, 12,18 24, and 30 months.
Control group	No intervention	–Control group only received usual care.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

1.at least 20 years old 2. diagnosed as stage 1-3 CKD (eGFR greater than ≧ 44 ml/min per 1.73 m2), 3. spoke Mandarin, 4.could be followed up every 6 months when they returned for a clinic outpatient visit.
-

Key exclusion criteria (3 listed)

could not participate in moderate exercise
not able to verbalize understanding of the study
already enrolled in another program.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lifestyle counseling ProgramAlso: tailored interventionsThe tailored intervention made use of the 10 processes of change, important guides for developing intervention programs, which have received the most empirical support to date. The 10 processes include consciousness raising, dramatic relief, self-reevaluation, environmental reevaluation, self-liberation, social liberation, counterconditioning, stimulus control, reinforcement management, and helping relations. The different tailored interventions were based on the processes of change matched to the patient's stage of change, providing strategies that may be especially helpful to patients. According to the Lenio analysis of the TTM model of behavior change, the first five processes are used in the early stages, and the last five are used in the later stages.	Behavioural	Intervention group

Primary outcome

The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
Time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention
The eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) formula (eGFR (ml/min/1.73 m2) = 186 × (SCr)-1.154 × (Age)-0.203 × (0.742 if female) (National Kidney Foundation, 2002). The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
Time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention
Waist circumference in centimeters was measured at the level midway between the lowest rib margin and the iliac crest at baseline, 6, 12, 18, 24, and 30 months for each intervention. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
Time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention
Hip circumference was measured at the widest area over the trochanters at 6, 12, 18, 24, and 30 months of every intervention. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
Time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention
The HPLP-II is validated, Self-report questionnaires Health promotion lifestyle was measured by the 52-item Health-Promoting Lifestyle-II (HPLP-II) Chinese questionnaire. The total scores of the HPLP-II are determined by calculating a mean item response. The HPLP-II uses mean sums of scale items to remain the 1 to 4 metric of item. Higher scores indicated better health-promoting lifestyle behaviors. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
Time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention
The renal protection checklist (RPK) is validated, Self-report questionnaires a disease-specific knowledge of renal protection checklist were developed by Yen, Huang, and Teng in 2008. The checklist consists of 20 items including three domains: renal function protection (11 items), knowledge of Chinese herbal medicine related to renal function (5 items), and diet with CKD (4 items). Item responses were "true" or "false." Each item is scored with 5 points for each correct answer. The total scores for the checklist range from 0-100. Higher scores indicate higher knowledge of renal function protection. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months
Time frame: The baseline and at 12, 24 months post intervention
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results presented the physical health QOL scores at each time point from baseline to 12, and 24 months.
The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months
Time frame: The baseline and at 12, 24 months post intervention
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results present the psychological health QOL scores from baseline to 12, and 24 Months.
The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months.
Time frame: The baseline and at 12, 24 months post intervention
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results present the Social Relationships QOL scores at each time point from baseline to 12, and 24 months.
The Results of Environment QOL Scores From Baseline to 12, and 24 Months
Time frame: The baseline and at 12, 24 months post intervention
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results present the Environment QOL scores at each time point from baseline to 12, 24 months.
The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months
Time frame: The baseline and at 12, 24 months post intervention
The Perceived self-efficacy of physical activity is validated, and the Self-report questionnaire. The perceived self-efficacy scale was used to measure perceived self-efficacy for physical activity. Fifteen items are answered on a six-point Likert scale ranging from 1 (completely uncertain) to 6 (completely certain). The total score ranges from 15-90, with a higher score representing greater perceived self-efficacy for physical activity. The results present the Perceived self-efficacy of physical activity scores at each time point from baseline to 12, and 24 months.
The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months
Time frame: The baseline and at 12, 24 months post intervention
The Decisional Balance Scale measures the perceived benefits and barriers of physical activity on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The scale of the benefits of changing physical activity behaviors (14 items) and the total score range from 14-84. The higher the scores represent the perceived benefits of physical activity is higher. The results present the Decisional balance (perceived benefits of physical activity) scores at each time point from baseline to 12, and 24 months.
The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months
Time frame: The baseline and at 12, 24 months post intervention
The Decisional Balance Scale measures the perceived benefits and barriers of physical activity on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The scale of the barrier of changing physical activity behaviors (15 items) and the total score range from 15-90. The higher the scores represent the perceived barrier to physical activity is higher. The results present the Decisional Balance (Perceived Barrier of Physical Activity) scores at each time point from baseline to 12, and 24 months.

Results and safety

Results posted to the registry on 28 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lifestyle Counseling Program	60	52
Usual Care	60	51

Primary outcome: The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months

Time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention. Mean (Standard Deviation). Unit: ml/min/1.73 m2

Measure	Intervention Group n = 60	Control Group n = 60
baseline	74.3 (8.77)	78.7 (14.06)
6 Month	74.04 (9.21)	79.20 (15.39)
12 Month	74.41 (9.35)	79.16 (15.36)
18 Month	74.85 (9.51)	79.45 (15.83)
24 Month	74.34 (8.96)	78.33 (14.55)
30 Month	74.97 (9.31)	78.39 (15.13)

Intervention Group vs Control Group: Mean Difference (Net): -4.4, p = 0.01, Mixed Models Analysis

Population analysed: Intend to Treat population (all participants assign to intervention or control group).

Primary outcome: The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months

Time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention. Mean (Standard Deviation). Unit: cm

Measure	Intervention Group n = 60	Control Group n = 60
baseline	93.2 (8.63)	98.6 (9.35)
6 month	92.88 (8.774)	98.7 (9.49)
12 month	93.21 (9.54)	99.23 (9.54)
18 month	93.49 (9.45)	99.13 (9.84)
24 month	92.57 (9.45)	98.96 (9.13)
30 month	91.96 (9.49)	99.27 (9.28)

Intervention Group vs Control Group: Mean Difference (Net): -5.4, p = 0.001, Mixed Models Analysis

Population analysed: Intend to Treat population (all participants assign to intervention or control group).

Primary outcome: The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months

Time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention. Mean (Standard Deviation). Unit: cm

Measure	Intervention Group n = 60	Control Group n = 60
baseline	102.24 (7.46)	104.33 (8.11)
6 months	101.81 (6.54)	104.34 (8.39)
12 months	101.59 (7.50)	103.94 (8.34)
18 months	101.90 (7.63)	102.85 (7.35)
24 months	101.25 (8.06)	103.28 (7.62)
30 monyths	100.31 (7.65)	103.51 (8.07)

Intervention Group vs Control Group: Mean Difference (Net): -2.09, p = 0.04, Mixed Models Analysis

Population analysed: Intend to Treat population (all participants assign to intervention or control group).

Primary outcome: The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months

Time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention Group n = 60	Control Group n = 60
Baseline	2.68 (0.50)	2.59 (0.40)
6 months	2.66 (0.50)	2.58 (0.46)
12 months	2.74 (0.50)	2.66 (0.50)
18 months	2.78 (0.52)	2.64 (0.54)
24 months	2.86 (0.52)	2.62 (0.54)
30 months	2.90 (0.50)	2.62 (0.50)

Intervention Group vs Control Group: Mean Difference (Net): 0.1, p = 0.04, Mixed Models Analysis

Population analysed: Intend to Treat population (all participants assign to intervention or control group).

Adverse events

Time frame: 30 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Control Group	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Limitations and caveats (from the sponsor): The data are not representative of all CKD patients, as the study sample had a male overrepresentation and the subjects were all in stages 1-3.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31496632Araujo-Soares V, Hankonen N, Presseau J, Rodrigues A, Sniehotta FF. Developing Behavior Change Interventions for Self-Management in Chronic Illness: An Integrative Overview. Eur Psychol. 2019;24(1):7-25. doi: 10.1027/1016-9040/a000330. Epub 2018 Aug 16.
Background: PubMed 24580088Barzin M, Hosseinpanah F, Serahati S, Salehpour M, Nassiri AA, Azizi F. Changes in waist circumference and incidence of chronic kidney disease. Eur J Clin Invest. 2014 May;44(5):470-6. doi: 10.1111/eci.12253.
Background: PubMed 27472690Chang PY, Chien LN, Lin YF, Wu MS, Chiu WT, Chiou HY. Risk factors of gender for renal progression in patients with early chronic kidney disease. Medicine (Baltimore). 2016 Jul;95(30):e4203. doi: 10.1097/MD.0000000000004203.
Background: PubMed 29146142Chen YC, Lai SH, Tsai YW, Chang SS. Visceral Adiposity Index as a Predictor of Chronic Kidney Disease in a Relatively Healthy Population in Taiwan. J Ren Nutr. 2018 Mar;28(2):91-100. doi: 10.1053/j.jrn.2017.07.006. Epub 2017 Nov 14.
Background: PubMed 21414969Chen SH, Tsai YF, Sun CY, Wu IW, Lee CC, Wu MS. The impact of self-management support on the progression of chronic kidney disease--a prospective randomized controlled trial. Nephrol Dial Transplant. 2011 Nov;26(11):3560-6. doi: 10.1093/ndt/gfr047. Epub 2011 Mar 17.
Background: PubMed 24892770Coresh J, Turin TC, Matsushita K, Sang Y, Ballew SH, Appel LJ, Arima H, Chadban SJ, Cirillo M, Djurdjev O, Green JA, Heine GH, Inker LA, Irie F, Ishani A, Ix JH, Kovesdy CP, Marks A, Ohkubo T, Shalev V, Shankar A, Wen CP, de Jong PE, Iseki K, Stengel B, Gansevoort RT, Levey AS; New Collective Author. Decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality. JAMA. 2014 Jun 25;311(24):2518-2531. doi: 10.1001/jama.2014.6634.
Background: PubMed 27417624Fischer F, Lange K, Klose K, Greiner W, Kraemer A. Barriers and Strategies in Guideline Implementation-A Scoping Review. Healthcare (Basel). 2016 Jun 29;4(3):36. doi: 10.3390/healthcare4030036.
Background: PubMed 26709057Fung E, Kurella Tamura M. Epidemiology and Public Health Concerns of CKD in Older Adults. Adv Chronic Kidney Dis. 2016 Jan;23(1):8-11. doi: 10.1053/j.ackd.2015.10.001.
Background: PubMed 32061315GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
Background: PubMed 17059992Hsu CC, Hwang SJ, Wen CP, Chang HY, Chen T, Shiu RS, Horng SS, Chang YK, Yang WC. High prevalence and low awareness of CKD in Taiwan: a study on the relationship between serum creatinine and awareness from a nationally representative survey. Am J Kidney Dis. 2006 Nov;48(5):727-38. doi: 10.1053/j.ajkd.2006.07.018.
Background: PubMed 30078513Jha V, Modi GK. Getting to know the enemy better-the global burden of chronic kidney disease. Kidney Int. 2018 Sep;94(3):462-464. doi: 10.1016/j.kint.2018.05.009. Epub 2018 Aug 3.
Background: PubMed 28057311Lee MC, Wu SV, Hsieh NC, Tsai JM. Self-Management Programs on eGFR, Depression, and Quality of Life among Patients with Chronic Kidney Disease: A Meta-Analysis. Asian Nurs Res (Korean Soc Nurs Sci). 2016 Dec;10(4):255-262. doi: 10.1016/j.anr.2016.04.002. Epub 2016 May 13.
Individual participant dataSharing planned: No. De-identified individuals participants data for all primary and secondary outcome measures.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Miaofen Yen, Doctor principal investigator

National Cheng Kung University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle counseling Program in people with Chronic Kidney Diseases and Health Behaviors, run by National Cheng Kung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months (time frame: The baseline and at 6, 12, 18, 24, and 30 months post intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01194518, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.