Dietary Modification
Conditions
Brief summary
This study is a prospective randomized controlled pilot trial/(a combined prospective and retrospective study). The investigators will use wechat intervening dietary protein intake in patients treated with peritoneal dialysis.
Detailed description
Malnutrition is highly prevalent in peritoneal dialysis (PD) patients, and protein malnutrition will adversely affect outcomes. The investigators develop a dietary education intervention for PD patients to improve fundamental food knowledge that will increase protein intake to target level of 1.2 g/kg of protein intake per day. In additional the dietary intervention will provide information about sodium, phosphorus, calcium intake. To more effectively deliver the intervention, the investigators explored a technology using social media in China called wechat. The purpose of this study is to test whether a dietary intervention can be more effective when delivered using wechat compared to a traditional patient education intervention delivered during routing clinical visits.
Interventions
BEHAVIORALwechat
The wechat model of dietary education every 1 month by cellphone
Sponsors
Baxter Healthcare Corporation
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. All patients followed at the PD center who successful completed training and have received treatment for at least 1 month. * 2\. The life expectancy will be more than one year. * 3\. All patients will provide written informed consent.
Exclusion criteria
* 1.the patients will be severe ill status and unlikely to survive for 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalized Protein Catabolic Rate (nPCR) | 12 months | We use software (PD ADEQUEST 2.0) to conduct the Peritoneal Equilibration Test (PET) test. The result of PET test can offered the value of nPCR. nPCR can estimate daily protein intake of patients. Its units is g/(kg\*d). |
Participant flow
Recruitment details
Patients were retrospectively from January 2014 to January 2015 and prospectively enrolled from Apr. 2015 to Apr. 2017 in the control group. Patients were prospectively enrolled in intervention with wechat group from Apr. 2015 to Apr. 2017.
Participants by arm
| Arm | Count |
|---|---|
| Intervention With Wechat Group The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline.
wechat: The wechat model of dietary education every 1 month by cellphone | 59 |
| Controlled Group Only conventional education every 3 months during routing clinical visit. The patients is Prospectively and retrospectively enrolled | 54 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Allergic to egg white | 1 | 0 |
| Overall Study | Death | 2 | 2 |
| Overall Study | Kidney transplant | 3 | 0 |
| Overall Study | Lost to Follow-up | 0 | 9 |
| Overall Study | transfer to hemodialysis | 5 | 5 |
Baseline characteristics
| Characteristic | Intervention With Wechat Group | Controlled Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 54 Participants | 113 Participants |
| Age, Continuous | 46.3390 years STANDARD_DEVIATION 13.8621 | 48.0926 years STANDARD_DEVIATION 13.3985 | 47.17699 years STANDARD_DEVIATION 13.61015 |
| Normalized Protein Catabolic Rate (nPCR) | 0.889 g/(Kg*d) STANDARD_DEVIATION 0.202 | 0.862 g/(Kg*d) STANDARD_DEVIATION 0.186 | 0.876 g/(Kg*d) STANDARD_DEVIATION 0.194 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 59 Participants | 54 Participants | 113 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 59 participants | 54 participants | 113 participants |
| Sex: Female, Male Female | 25 Participants | 20 Participants | 45 Participants |
| Sex: Female, Male Male | 34 Participants | 34 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 70 | 2 / 70 |
| other Total, other adverse events | 1 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Normalized Protein Catabolic Rate (nPCR)
We use software (PD ADEQUEST 2.0) to conduct the Peritoneal Equilibration Test (PET) test. The result of PET test can offered the value of nPCR. nPCR can estimate daily protein intake of patients. Its units is g/(kg\*d).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention With Wechat Group | Normalized Protein Catabolic Rate (nPCR) | 1.038 g/(kg*d) | Standard Deviation 0.188 |
| Controlled Group | Normalized Protein Catabolic Rate (nPCR) | 0.930 g/(kg*d) | Standard Deviation 0.175 |