None listed
Conditions
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.
Interventions
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.
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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.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed