Dietary ModificationDIPIPDNCT02426580

Dietary Education Intervention Impact on Dietary Protein Intake in PD

A study testing wechat in people with Dietary Modification, run by The Second Affiliated Hospital of Chongqing Medical University.

Completed

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

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Dietary Modification
What is being tested?: wechat
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: No sites listed yet
Study dates: Apr 2015to May 2018
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

1.the patients will be severe ill status and unlikely to survive for 12 months.

About this study

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

Read the 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.

Conditions: Dietary Modification
Being tested: wechat

What participants receive

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

wechatBehavioural
Also called wechat model
The wechat model of dietary education every 1 month by cellphone

Study groups in NCT02426580
Study group	Role	What they receive
Intervention with wechat group	Experimental	The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline. Receives: Behavioral: wechat
Controlled group	No intervention	Only conventional education every 3 months during routing clinical visit

What is being measured

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

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).
Measured: 12 months

Timeline

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

Apr 2015May 2018

First posted27 Apr 2015 (estimated)
Study startApr 2015
Primary completionApr 2017
Study completionMay 2018

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 Dietary ModificationStudies 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: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02426580
Sponsor's protocol ID: Chengdu 3rd Hospital
Acronym: DIPIPD
Status last verified: Jul 2019
First submitted: 22 Apr 2015
Last updated: 10 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: We would like to share the study protocol, study reports and informed consent form with other researchers.

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?

Official record

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy

All Dietary Modification trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dietary Education Intervention With Wechat Model Will Impact on Dietary Protein Intake in Patient Treated With Peritoneal Dialysis
ClinicalTrials.gov ID: NCT02426580
Acronym / sponsor ID: DIPIPD / Chengdu 3rd Hospital
Conditions: Dietary Modification
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
Collaborators: Baxter Healthcare Corporation
Study start: Apr 2015 (actual)
Primary completion: Apr 2017 (actual)
Study completion: May 2018 (actual)
First posted: 27 Apr 2015 (estimated)
Results: Posted 17 Jun 2019

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: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention with wechat group	Experimental	Behavioral: wechatThe wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline.
Controlled group	No intervention	–Only conventional education every 3 months during routing clinical visit

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

1.the patients will be severe ill status and unlikely to survive for 12 months.

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
wechatAlso: wechat modelThe wechat model of dietary education every 1 month by cellphone	Behavioural	Intervention with wechat group

Primary outcome

Normalized Protein Catabolic Rate (nPCR)
Time frame: 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).

Results and safety

Results posted to the registry on 17 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention With Wechat Group	70	59
Controlled Group	70	54

Primary outcome: Normalized Protein Catabolic Rate (nPCR)

Time frame: 12 months. Mean (Standard Deviation). Unit: g/(kg*d)

Measure	Intervention With Wechat Group n = 59	Controlled Group n = 54
Value	1.038 (0.188)	0.930 (0.175)

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention With Wechat Group	0 of 70 (0%)	1 of 70 (1.4%)	2 of 70
Controlled Group	0 of 70 (0%)	0 of 70 (0%)	2 of 70

Limitations and caveats (from the sponsor): It is not a randomized controlled study. The patients assigned to both groups according to their willing. Most enrolled to intervention group. To improve the amount of control group, we retrospectively recruited 35 patients from recent 1 year.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. We would like to share the study protocol, study reports and informed consent form with other researchers.

Related trials for Dietary Modification

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing wechat in people with Dietary Modification, run by The Second Affiliated Hospital of Chongqing Medical University.

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 3 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

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 17 Jun 2019). 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?

Normalized Protein Catabolic Rate (nPCR) (time frame: 12 months). 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 NCT02426580.

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 10 Jul 2019.