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Trial registered on ANZCTR

Registration number

ACTRN12617000558325

Ethics application status

Approved

Date submitted

28/03/2017

Date registered

21/04/2017

Date last updated

21/04/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Can a smart phone application assist in reducing dietary phosphate and sodium intake?

Scientific title

Can healthy individuals using a smart phone application reduce their dietary phosphate or sodium intake as well as, or better than, healthy individuals provided with standard dietetic advice

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1166-5130

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dietary sodium and phosphate intake

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

We will recruit healthy volunteers to the study.

After providing potential participants with study information and receiving their informed consent, we will obtain urine for a urinalysis, check a blood pressure and assess for any history of kidney disease or use of medications likely to influence urine sodium or phosphate values. Participants with a normal urinalysis, blood pressure and without any history of kidney disease or use of those medications will meet entry criteria for the study.

Participants will then be randomly allocated to either an 'intervention group' or a control 'usual care group'.

All participants then undergo baseline investigations: Participants will be asked to maintain a food diary for 3 days to assess baseline dietary sodium and phosphate intake.
Body mass index (BMI) will be assessed. A baseline 24 hour urine sample will be collected for urine volume, creatinine, sodium and phosphate.

We will then ask all the participants to 'moderately' reduce their sodium and phosphate intake for the next 2 weeks. For the purposes of this study, ‘moderate’ reduction refers to the dietary sodium and phosphate targets used as therapeutic targets for dietary modification for people with end stage kidney disease. These targets are based on systematic reviews of dietary trials. A moderate reduction here refers to a therapeutic diet with less than 100mmol of Na per day and less than 1000mg of phosphate per day.

To achieve this moderate reduction, all participants will be provided with a dietary leaflet, which provides advice on strategies to achieve the reduction, The dietary leaflet used in this study is identical to the leaflet used in clinical care in the Illawarra Shoalhaven Local Health District.

Further instruction will occur via a telephone interview with a trained dietician in the following way; Participants will be provided with feedback about their baseline diet and provided with individualised advice on how to reduce dietary sodium and phosphate to the target levels. . This intervention replicates what would happen in real life clinical care conditions with a patient with chronic kidney disease if they were seen by a dietician as an outpatient. The baseline interview with the dietician is expected to be no more than 1 hour, which replicates the usual time taken for an initial interview with a renal dietician in clinical care.

Intervention group: Participants allocated to the intervention group will be instructed on the use of a dietary smart phone application (app), which they will be able to use to monitor their sodium and phosphate targets. The app is an extension to an existing smart phone app that uses the foodworks TM database, This database accesses Australian food products and is widely used by dieticians. The app will include information on the sodium and phosphate content of common processed and unprocessed foods and can be used to look up the content of packaged foods using the food's bar code. The app works out the intake values, based on food varieties and brands entered by the participant or from the bar code on packaged foods, using the camera on the smart phone. Instruction on use of the app will be provided by one of the researchers (who is not a dietician) and is expected to take up to 30 minutes. Participants will be encouraged to use the app to enter their food choices on a daily basis. Once entered for the 1st day, it is usually simple to add modifications to a recurring daily diet. Participants will also be encouraged to use the app to look up the sodium and phosphate content of foods if they are unsure whether the food has a high or low sodium or phosphate content.
No additional strategies will be used to increase adherence in the intervention group, as this study is a pragmatic study replicating real life conditions i.e. in future studies, if this protocol were used for patients with kidney disease, additional support to increase adherence would not be generally available.

We will ask all participants to perform a second 24 hour urine collection after 2 weeks.
Participants are also asked to complete a post intervention self report questionnaire to assess intervention adherence and ease of compliance to the suggested dietary modifications.

Intervention code [1]

Lifestyle

Comparator / control treatment

We will recruit healthy volunteers to the study.

After providing potential participants with study information and receiving their informed consent, we will obtain urine for a urinalysis, check a blood pressure and assess for any history of kidney disease or use of medications likely to influence urine sodium or phosphate values. Participants with a normal urinalysis, blood pressure and without any history of kidney disease or use of those medications will meet entry criteria for the study.
Participants will then be randomly allocated to either an 'intervention group' or a control 'usual care group'.

All participants then undergo baseline investigations: Participants will be asked to maintain a food diary for 3 days to assess baseline dietary sodium and phosphate intake.
Body mass index (BMI) will be assessed. A baseline 24 hour urine sample will be collected for urine volume, creatinine, sodium and phosphate.

We will then ask all the participants to 'moderately' reduce their sodium and phosphate intake for the next 2 weeks. For the purposes of this study, ‘moderate’ reduction refers to the dietary sodium and phosphate targets used as therapeutic targets for dietary modification for people with end stage kidney disease. These targets are based on systematic reviews of dietary trials. A moderate reduction here refers to a therapeutic diet with less than 100mmol of sodium per day and less than 1000mg of phosphate per day.
To achieve this moderate reduction, all participants will be provided with a dietary leaflet, which provides advice on strategies to achieve the reduction, The dietary leaflet used in this study is identical to the leaflet used in clinical care in the Illawarra Shoalhaven Local Health District.

Further instruction will occur via a telephone interview with a trained dietician in the following way; Participants will be provided with feedback about their baseline diet and provided with individualised advice on how to reduce dietary sodium and phosphate to the target levels. . This intervention replicates what would happen in real life clinical care conditions with a patient with chronic kidney disease if they were seen by a dietician as an outpatient. The baseline interview with the dietician is expected to be no more than 1 hour, which replicates the usual time taken for an initial interview with a renal dietician in clinical care.

Control group: No additional strategies will be used to increase adherence in the control group, as this study is a pragmatic study replicating real life conditions i.e. in future studies, if this protocol were used for patients with kidney disease, additional support to increase adherence would not be generally available. .

We will ask all participants to perform a second 24 hour urine collection after 2 weeks. Participants are also asked to complete a post intervention self report questionnaire to assess intervention adherence and ease of compliance to the suggested dietary modifications.

Control group

Active

Outcomes

Primary outcome [1]

Within group change in 24 hour urinary sodium values.

Timepoint [1]

The time point at which we measuring this outcome is at 2 weeks.

Primary outcome [2]

Within group change in 24 hour urinary phosphate values.

Timepoint [2]

The time point at which we measuring this outcome is at 2 weeks.

Secondary outcome [1]

Between group comparison of ease of dietary compliance for the standard advice and the smart phone app. will be assessed by questionnaire designed specifically for this study.
This questionnaire contains:
Eleven question on acceptability and useability of the three day food diary for all participants.
Five questions on compliance for all participants .
Fourteen question s about ease of use of the app for intervention group users only.
Responses will be completed on a 5-point Likert scale.
In addition, there will be 5 free text questions asking for comments in which participants could provide opinions or describe experiences.

Timepoint [1]

The time point at which we measuring this outcome is at 2 weeks.

Eligibility

Key inclusion criteria

This study requires healthy individuals to participate. The participants will be recruited by advertising the project at the University of Notre Dame Sydney. It is expected that medical students will be the participants.

Minimum age

18 Years

Maximum age

50 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

The exclusion criteria are any participants: using medication likely to affect their urinary sodium or phosphate levels (such as diuretics or calcium supplements), or with an abnormal baseline urinalysis (UA) for protein, glucose, blood, white cells or albumin), an abnormal resting blood pressure or a history of kidney disease.

These participants will only be excluded to avoid confounding factors in their results.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Block randomisation will be used for allocation of the participants to either of the 2 dietary interventions (AABB, ABAB, ABBA, BABA, BAAB, BBAA).

For allocation, contact will be made by telephone with the holder of the allocation schedule who will be off-site.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Participants cannot be blinded to use of the app or standard dietetic management.
All data from the study will be entered to a statistical database in a deidentified fashion by a nurse blinded to the allocation of intervention.
The deidentified data will be analysed by the researchers blinded to allocation of the intervention until analyses are completed.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

SPPS will be used for analyses. Data will be tested for normal distribution and mean values will be compared using either Student T-tests (parametric) or Mann-Whitney U or Wilcoxon tests (non parametric). Differences from baseline to 2 weeks will be compared using Mann Whitney, and within group changes from baseline will be assessed using the Wilcoxon signed rank test. Correlations will be assessed using the Spearman rank correlation for non parametric data. P-values <0.05 will be considered statistically significant. The sample size to detect a statistically significant change from baseline to 2
weeks in phosphate with an expected effect size of 0.8 and power 0.95
p<0.05 is 10 participants..
The study will not aim to assess between group differences in urinary sodium, because the estimated sample size required is 123 participants in each group, which is outside the capabilities and budget of the research.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/06/2015

Date of last participant enrolment

Anticipated

Actual

30/09/2015

Date of last data collection

Anticipated

Actual

31/10/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Auburn Hospital & Community Health Services - Auburn

Recruitment postcode(s) [1]

2144 - Auburn

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Westmead Hospital

Address [1]

Cnr Hawesbury Road and Darcy Road
Westmead, NSW, 2145

Country [1]

Australia

Primary sponsor type

Government body

Name

Western Sydney Local Health District

Address

WSLHD HREC
Westmead Hospital,
Cnr Hawesbury Road and Darcy Road
Westmead, NSW, 2145

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Notre Dame, Australia

Address [1]

32 Mouat St, Fremantle WA 6160

PO Box 1225, Fremantle, WA 6959

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District HREC

Ethics committee address [1]

WSLHD HRE Officer
Westmead Research Office
Research & Education Network
PO Box 533
Wentworthville NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/02/2015

Approval date [1]

11/05/2015

Ethics approval number [1]

(ECOO152)

Summary

Brief summary

The purpose of the study is to investigate whether using a smart phone application can assist in the reduction of intake of foods which contain phosphate and sodium by helping people to adhere to a diet. We believe that using this app will help people adhere to a diet over a 2 week period. We will measure whether this has happened by collecting a sample of all the urine passed over 24 hours at both the beginning and end of the 2 week period and compare the result from that to others in the study who receive routine dietetic advice. Once all of the data has been collected, the researchers will aim to see whether the app has been helpful or not and to see if it can be used as a valid research tool in future experiments. 

Participants will then be asked for some information about themselves including: 

1. Age, weight, gender, height, blood pressure, body mass index.
2. A food questionnaire and 3 day food record. 

Participation in the trial will require the following procedures:
1. A urine analysis 
2. A 24 hour urinary collection for phosphate, sodium, creatinine and urine volume

Participating in the trial will require some restrictions upon lifestyle during the study. These include changing ones diet to one which contains low levels of phosphate and sodium. Participants will be allocated in a group:

1.Diet sheets outlining dietary measures, including foods to avoid, to achieve the required dietary sodium and phosphate reduction (given out and explained by the student investigator), plus a telephone interview with a trained dietician in which the dietary intervention will be further explained and reinforced. 

2.Instructions on the use of the dietary app, which participants will be able to use to monitor their sodium and phosphate targets. The app will be supplied on an iPad and taught how to use the app. Use of the app will be explained by the student investigator. This app has many functions including allowing users to input their dietary intake on a daily basis. It then keeps a running tally of nutrient intake and allows users to identify the nutrient content of individual foods, bar scans foods and indicates how well users are meeting or exceeding nutrient targets.
All trial participants will be asked to keep a 3 day food diary (either via the app or via usual paper food diary) prior to the final repeat urine collection.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Grahame Elder

Address

Department of Renal Medicine,
Westmead Hospital, Cnr Darcy and Hawesbury Roads
Westmead, NSW, 2145

Country

Australia

Phone

+612 98456962

Fax

+61 2 96339351

[email protected]

Contact person for public queries

Name

Grahame Elder

Address

Department of Renal Medicine,
Westmead Hospital, Cnr Darcy and Hawesbury Roads
Westmead, NSW, 2145

Country

Australia

Phone

+61 2 98456962

Fax

+61 2 96339351

[email protected]

Contact person for scientific queries

Name

Grahame Elder

Address

Department of Renal Medicine,
Westmead Hospital, Cnr Darcy and Hawesbury Roads
Westmead, NSW, 2145

Country

Australia

Phone

+61 2 98456962

Fax

+61 2 96339351

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Role of dietary phosphate restriction in chronic kidney disease.	2018	https://dx.doi.org/10.1111/nep.13188

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically