Chronic Kidney DiseasesCKD lifestyleNCT02076256
Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With CKD( CKD Lifestyle)
A study testing helping relationships in people with Chronic Kidney Diseases, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
This clinical trial aims to evaluate the effectiveness of a helping relationships intervention program for patients with chronic kidney disease (CKD). The study investigates whether support and involvement from significant others can assist CKD patients in adopting and maintaining health-promoting behaviors, thereby… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- helping relationships
- 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
- Sep 2015to Sep 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 years and older
- diagnosed with chronic kidney disease stage 1 to 4 or GFR≧30ml/min/1.73m2
- patients who has significant others
- patients who can speak Mandarin or Taiwanese
Who cannot join
- Patient who limited to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study
This clinical trial aims to evaluate the effectiveness of a helping relationships intervention program for patients with chronic kidney disease (CKD). The study investigates whether support and involvement from significant others can assist CKD patients in adopting and maintaining health-promoting behaviors, thereby potentially delaying disease progression.
A total of 120 CKD patients will be enrolled and randomly assigned to either an experimental group or a control group. The experimental group will receive the helping relationships intervention program, while the control group will receive routine nursing care. The primary objective is to assess the impact of this intervention on patients' healthy lifestyles, stages of behavior change, and overall quality of life over a 12-month follow-up period.
Read the detailed description
The intervention study was conducted from 2015 to 2016, and the statistical analyses reflect this specific intervention phase. A total of 120 patients were enrolled and randomly assigned to either the control or experimental group. Baseline assessments included physical indicators (such as body mass index, waist circumference, hip circumference, waist-hip ratio, systolic blood pressure, diastolic blood pressure) and clinical biomarkers (BUN, creatinine, HbA1C, and Modification of Diet in Renal Disease [MDRD]).
The Generalized Estimating Equation (GEE) model was utilized to determine whether outcome variables (healthy lifestyle, stage of change, and quality of life) differed across time between the experimental and control groups. To control for potential confounding effects, specific variables, including the comorbidity index and helping relationships from significant others, were pre-specified to be included as covariates for adjustment in the GEE model.
- Conditions
- Chronic Kidney Diseases
- Being tested
- helping relationships
- Keywords
- healthy lifestyle, stage of change, physical indicators
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
helping relationshipsBehavioural
Also called health lifestyles
helping relationships intervention included understanding, caring, and coaching healthy lifestyles included regular exercise and take disease related diet
| Study group | Role | What they receive |
|---|---|---|
| Helping relationships intervention group | Experimental | Patients in the intervention group received the same education program for pre-end-stage renal disease and stage-tailored strategies as the control group.
The research team designed interventions to help relationships of significant others, including understanding, caring, and coaching for the significant other according to the patient's readiness-to-change stages.
Follow up every three months Receives: Behavioral: helping relationships |
| Helping relationships control group | No intervention | Patients in the control group attended an education program on pre-end-stage renal disease and stage-tailored strategies to facilitate exercise and diet behaviors for one year. Follow up every three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Health-Promoting Lifestyle(the Third Yea
The Health Promoting Lifestyle Profile-II Chinese questionnaire was used to investigate health-promoting lifestyles. The questionnaire has 52 items and six subscales of health promotion, including health responsibility (nine items), physical activity (eight items), nutrition (nine items), spiritual growth (nine items), interpersonal relations (nine items), and stress management (eight items). Using a four-point Likert-type scale from 1 (never) to 4 (routine), the item scores of health-promoting lifestyles were assessed. For this outcome, an overall mean score was calculated by averaging the responses across the items. The possible range for this mean score is from 1 to 4, with higher scores indicating a higher frequency of engaging in health-promoting behaviors.
Measured: Baseline and every 3 months up to 12 months
Stage of Change of Exercise Behaviors
The instrument of Stage of Change of Exercise based on the transtheoretical model, including five statements reflecting the five stages of change, was used to determine participants' stage of change through their self-reports.
There are five stages in the Stage of Change Diet Behaviors based, including Precontemplation, Precontemplation , Preparation , Action , and Maintenance. Precontemplation, Contemplation, and Preparation were recoded into the preaction group. Action and Maintenance were recoded into the action/maintenance group
Measured: Baseline and every 3 months up to 12 months
Stage of Change of Diet Behaviors
The instrument of Stage of Change of Diet based on the transtheoretical model, including five statements reflecting the five stages of change, was used to determine participants' stage of change through their self-reports.
There are five stages in the Stage of Change Diet Behaviors based, including Precontemplation, Precontemplation , Preparation , Action , and Maintenance. This study was pooled with the precontemplation, contemplation, and preparation stages into the pre-action stage, and the action and maintenance stages into the action/maintenance stage ( Johnson et al., 2008 ) for corrected bias.
Measured: Baseline and every 3 months up to 12 months.
WHOQOL-BREF
The World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) instrument comprises 28 items with 4 domains such as physical health, psychological health, social relationships, and environment. Its 5-Likert scales calculated items, which the minimum is 1 and the maximum is 5. Higher scores indicated greater Quality of Life. The overall mean scores of Quality of Life = (physical + psychological + social relationships + environment)/28. The total score ranged from 28 to 140.Range scores 7-35 in physical domain, 6-30 in psychological domain, 4-20 in social domain, 9-45 in environmental domain.
Measured: Baseline and every 6 months up to 12 months
Body Mass Index
Body mass index (BMI) is a widely used measure of obesity for determining ideal body weight, compared with an individual's weight and height.
Measured: Baseline and every 3 months up to 12 months
Waist Circumference
Waist circumference is a simple method to assess abdominal adiposity and is strongly associated with all-cause cardiovascular mortality.
Measured: Baseline and every 3 months up to 12 months
Hip Circumference
Hip circumference assesses skeletal frame size and adipose and muscle mass in the buttock and thigh regions that show a high association with the size of the respective fat depots.
Measured: A repeated measure every 3 months over a 12-month period.
Waist-hip Ratio
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips.
Measured: A repeated measure every 3 months over a 12-month period.
Systolic BP
Systolic blood pressure is the top number and refers to the amount of pressure experienced by the arteries while the heart is beating.
Measured: A repeated measure every 3 months over a 12-month period.
Diastolic BP
Diastolic blood pressure is the bottom number and refers to the amount of pressure in the arteries while the heart is resting in between heartbeats.
Measured: A repeated measure every 3 months over a 12-month period.
Estimated Glomerular Filtration Rate (eGFR) Calculated by the MDRD Equation
Renal function was assessed by calculating the estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) study equation. The equation utilizes serum creatinine levels, age, and sex to estimate kidney function. The values reported in the data table represent the calculated eGFR. Higher values indicate better renal function, whereas lower values represent more severe renal impairment.
Measured: A repeated measure every 3 months over a 12-month period.
Blood Urea Nitrogen
Blood Urea Nitrogen (BUN) levels measured in mg/dL to assess renal function and metabolic status.
Measured: A repeated measure every 3 months over a 12-month period.
Creatinine
Creatinine measures kidney function by assessing waste filtration from blood. Elevated levels signal potential kidney damage or disease.
Measured: A repeated measure every 3 months over a 12-month period.
HbA1C
HbA1c assesses average blood sugar over 2-3 months, diagnosing diabetes (≥6.5%) and monitoring control; normal <5.7%
Measured: A repeated measure every 3 months over a 12-month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The strategies of helping relationships focused on healthy eating (e.g., low-salt and low-fat diet), physical activity (e.g., doing exercise), and disease management (e.g., adherence to health care providers' suggestions). Based on the TTM, the most effective strategies for helping relationships should consider patients' intentions to engage in healthy lifestyle modification. The research team designed interventions to help relationships of significant others, including understanding, caring, and coaching for the significant other according to the patient's readiness-to-change stages.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng-Kung University Hospital, E-DA Hospital
- Responsible party
- Principal investigator, Miaofen Yen, National Cheng Kung University
- Investigators
- Miaofen Yen, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076256
- Sponsor's protocol ID
- MOST102-2314-B-006-013-MY3
- Other IDs
- NSC 99-2314-B-006-048-MY3
- Acronym
- CKD lifestyle
- Status last verified
- Jul 2026
- First submitted
- 21 Feb 2014
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: this study aimed to measure the effects of intervention strategies used by significant others in helping relationships with individuals with chronic kidney disease to advance from their baseline transtheoretical model stage of diet and exercise to the next stage of change, quality of life, health-promoting lifestyles among patients with chronic kidney disease.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT02076256
- Acronym / sponsor ID
- CKD lifestyle / MOST102-2314-B-006-013-MY3
- Conditions
- Chronic Kidney Diseases
- Keywords
- healthy lifestyle, stage of change, physical indicators
- 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
- Sep 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 23 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to evaluate the effectiveness of a helping relationships intervention program for patients with chronic kidney disease (CKD). The study investigates whether support and involvement from significant others can assist CKD patients in adopting and maintaining health-promoting behaviors, thereby potentially delaying disease progression.
A total of 120 CKD patients will be enrolled and randomly assigned to either an experimental group or a control group. The experimental group will receive the helping relationships intervention program, while the control group will receive routine nursing care. The primary objective is to assess the impact of this intervention on patients' healthy lifestyles, stages of behavior change, and overall quality of life over a 12-month follow-up period.
Detailed description
The intervention study was conducted from 2015 to 2016, and the statistical analyses reflect this specific intervention phase. A total of 120 patients were enrolled and randomly assigned to either the control or experimental group. Baseline assessments included physical indicators (such as body mass index, waist circumference, hip circumference, waist-hip ratio, systolic blood pressure, diastolic blood pressure) and clinical biomarkers (BUN, creatinine, HbA1C, and Modification of Diet in Renal Disease [MDRD]).
The Generalized Estimating Equation (GEE) model was utilized to determine whether outcome variables (healthy lifestyle, stage of change, and quality of life) differed across time between the experimental and control groups. To control for potential confounding effects, specific variables, including the comorbidity index and helping relationships from significant others, were pre-specified to be included as covariates for adjustment in the GEE model.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The strategies of helping relationships focused on healthy eating (e.g., low-salt and low-fat diet), physical activity (e.g., doing exercise), and disease management (e.g., adherence to health care providers' suggestions). Based on the TTM, the most effective strategies for helping relationships should consider patients' intentions to engage in healthy lifestyle modification. The research team designed interventions to help relationships of significant others, including understanding, caring, and coaching for the significant other according to the patient's readiness-to-change stages.
| Arm | Type | Receives |
|---|---|---|
| Helping relationships intervention group | Experimental | Behavioral: helping relationshipsPatients in the intervention group received the same education program for pre-end-stage renal disease and stage-tailored strategies as the control group. The research team designed interventions to help relationships of significant others, including understanding, caring, and coaching for the significant other according to the patient's readiness-to-change stages. Follow up every three months |
| Helping relationships control group | No intervention | –Patients in the control group attended an education program on pre-end-stage renal disease and stage-tailored strategies to facilitate exercise and diet behaviors for one year. Follow up every three months |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 years and older
- diagnosed with chronic kidney disease stage 1 to 4 or GFR≧30ml/min/1.73m2
- patients who has significant others
- patients who can speak Mandarin or Taiwanese
Key exclusion criteria (1 listed)
- Patient who limited to exercise
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 |
|---|---|---|
| helping relationshipsAlso: health lifestyleshelping relationships intervention included understanding, caring, and coaching healthy lifestyles included regular exercise and take disease related diet | Behavioural | Helping relationships intervention group |
Primary outcome
Overall Health-Promoting Lifestyle(the Third Yea
Time frame: Baseline and every 3 months up to 12 months
The Health Promoting Lifestyle Profile-II Chinese questionnaire was used to investigate health-promoting lifestyles. The questionnaire has 52 items and six subscales of health promotion, including health responsibility (nine items), physical activity (eight items), nutrition (nine items), spiritual growth (nine items), interpersonal relations (nine items), and stress management (eight items). Using a four-point Likert-type scale from 1 (never) to 4 (routine), the item scores of health-promoting lifestyles were assessed. For this outcome, an overall mean score was calculated by averaging the responses across the items. The possible range for this mean score is from 1 to 4, with higher scores indicating a higher frequency of engaging in health-promoting behaviors.
Stage of Change of Exercise Behaviors
Time frame: Baseline and every 3 months up to 12 months
The instrument of Stage of Change of Exercise based on the transtheoretical model, including five statements reflecting the five stages of change, was used to determine participants' stage of change through their self-reports. There are five stages in the Stage of Change Diet Behaviors based, including Precontemplation, Precontemplation , Preparation , Action , and Maintenance. Precontemplation, Contemplation, and Preparation were recoded into the preaction group. Action and Maintenance were recoded into the action/maintenance group
Stage of Change of Diet Behaviors
Time frame: Baseline and every 3 months up to 12 months.
The instrument of Stage of Change of Diet based on the transtheoretical model, including five statements reflecting the five stages of change, was used to determine participants' stage of change through their self-reports. There are five stages in the Stage of Change Diet Behaviors based, including Precontemplation, Precontemplation , Preparation , Action , and Maintenance. This study was pooled with the precontemplation, contemplation, and preparation stages into the pre-action stage, and the action and maintenance stages into the action/maintenance stage ( Johnson et al., 2008 ) for corrected bias.
WHOQOL-BREF
Time frame: Baseline and every 6 months up to 12 months
The World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) instrument comprises 28 items with 4 domains such as physical health, psychological health, social relationships, and environment. Its 5-Likert scales calculated items, which the minimum is 1 and the maximum is 5. Higher scores indicated greater Quality of Life. The overall mean scores of Quality of Life = (physical + psychological + social relationships + environment)/28. The total score ranged from 28 to 140.Range scores 7-35 in physical domain, 6-30 in psychological domain, 4-20 in social domain, 9-45 in environmental domain.
Body Mass Index
Time frame: Baseline and every 3 months up to 12 months
Body mass index (BMI) is a widely used measure of obesity for determining ideal body weight, compared with an individual's weight and height.
Waist Circumference
Time frame: Baseline and every 3 months up to 12 months
Waist circumference is a simple method to assess abdominal adiposity and is strongly associated with all-cause cardiovascular mortality.
Hip Circumference
Time frame: A repeated measure every 3 months over a 12-month period.
Hip circumference assesses skeletal frame size and adipose and muscle mass in the buttock and thigh regions that show a high association with the size of the respective fat depots.
Waist-hip Ratio
Time frame: A repeated measure every 3 months over a 12-month period.
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips.
Systolic BP
Time frame: A repeated measure every 3 months over a 12-month period.
Systolic blood pressure is the top number and refers to the amount of pressure experienced by the arteries while the heart is beating.
Diastolic BP
Time frame: A repeated measure every 3 months over a 12-month period.
Diastolic blood pressure is the bottom number and refers to the amount of pressure in the arteries while the heart is resting in between heartbeats.
Estimated Glomerular Filtration Rate (eGFR) Calculated by the MDRD Equation
Time frame: A repeated measure every 3 months over a 12-month period.
Renal function was assessed by calculating the estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) study equation. The equation utilizes serum creatinine levels, age, and sex to estimate kidney function. The values reported in the data table represent the calculated eGFR. Higher values indicate better renal function, whereas lower values represent more severe renal impairment.
Blood Urea Nitrogen
Time frame: A repeated measure every 3 months over a 12-month period.
Blood Urea Nitrogen (BUN) levels measured in mg/dL to assess renal function and metabolic status.
Creatinine
Time frame: A repeated measure every 3 months over a 12-month period.
Creatinine measures kidney function by assessing waste filtration from blood. Elevated levels signal potential kidney damage or disease.
HbA1C
Time frame: A repeated measure every 3 months over a 12-month period.
HbA1c assesses average blood sugar over 2-3 months, diagnosing diabetes (≥6.5%) and monitoring control; normal <5.7%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Helping relationships for smoking cessation: grounded theory development of the process of finding help to quit.Link provided by the sponsor.
- Partner behaviors that support quitting smoking.Link provided by the sponsor.
- Social Relationships and health.Link provided by the sponsor.
- Association of dyslipidemia with renal outcomes in chronic kidney disease.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. this study aimed to measure the effects of intervention strategies used by significant others in helping relationships with individuals with chronic kidney disease to advance from their baseline transtheoretical model stage of diet and exercise to the next stage of change, quality of life, health-promoting lifestyles among patients with chronic kidney disease.
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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 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 helping relationships in people with Chronic Kidney Diseases, 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 4 inclusion and 1 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 23 Oct 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 23 Oct 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?
Overall Health-Promoting Lifestyle(the Third Yea (time frame: Baseline and every 3 months up to 12 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.