Dietary Education Intervention Impact on Dietary Protein Intake in PD (DIPIPD)

Dietary Education Intervention With Wechat Model Will Impact on Dietary Protein Intake in Patient Treated With Peritoneal Dialysis

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.

Study Overview

• Status: Completed
• Conditions: Dietary Modification
• Intervention / Treatment: Behavioral: wechat

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: wechat; The wechat model of dietary education every 1 month by cellphone; Other Names: wechat model
No Intervention: Controlled group; Only conventional education every 3 months during routing clinical visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Chengdu 3rd Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We would like to share the study protocol, study reports and informed consent form with other researchers.
• IPD Sharing Time Frame: The data will become available at May 2019 and for 2 years
• IPD Sharing Access Criteria: No criteria.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR