UnknownNot Applicable

Validation and Evaluation of a Newly Developed Mobile Diet App

Malaysia90 participantsStarted 2023-02-15

Plain-language summary

A 12-week, prospective, multicenter, open-label pilot randomized controlled trial (RCT) will be carried out to determine the feasibility, acceptability and potential clinical efficacy of a newly developed mobile diet app among CKD populations at different stages in Malaysia. Participants will be randomly assigned into either (i) intervention group (mobile diet app) or (ii) control group (dietary counseling using conventional pamphlet).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Clinically diagnosed CKD / eGFR \< 60 ml/min/1.73m2 for ≥ 3 months (only applicable to pre-dialysis patients.
✓. Undergone maintenance dialysis for at least 3 months (only applicable to dialysis patients)
✓. Possessing smartphone and is willing to use health app
✓. Alert and oriented
✓. At least 18 years of age

Exclusion criteria

✕. Inability to use the smartphone app (e.g. due to vision problems)
✕. Hard to comply with home monitoring (e.g. suffering from anxiety or depression)
✕. Refuse to comply with dietary prescription
✕. Patients who participate in other study at the same time
✕. Patients who have participated in another research study involving an investigational product in the past 12 weeks preceding enrollment.
✕. Planning for kidney transplant over the study duration.
✕. Female patients who are pregnant, lactating or planning a pregnancy during the course of the trial.
✕. Participants who are receiving nutritional support (i.e. enteral and intra-venous route).

What they're measuring

Glomerular Filtration Rate (eGFR)

Timeframe: 3 months

Serum Kidney Function Test

Timeframe: 3 months

Serum Hemoglobin A1C Test

Timeframe: 3 months

Serum Blood Sugar Profile

Timeframe: 2 weeks

Albuminuria

Timeframe: 12 weeks

Dietary History

Timeframe: 6 weeks

Dietary Adherence

Timeframe: 6 weeks

Trial details

NCT IDNCT04336033

SponsorUniversiti Putra Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-30

Contact for this trial

Nor Fadhlina binti Zakaria, Nephrologist

+603 8947 2561 fadhsara@yahoo.com

View on ClinicalTrials.gov More Chronic Kidney Diseases trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Clinically diagnosed CKD / eGFR \< 60 ml/min/1.73m2 for ≥ 3 months (only applicable to pre-dialysis patients.
✓. Undergone maintenance dialysis for at least 3 months (only applicable to dialysis patients)
✓. Possessing smartphone and is willing to use health app
✓. Alert and oriented
✓. At least 18 years of age

Exclusion criteria

✕. Inability to use the smartphone app (e.g. due to vision problems)
✕. Hard to comply with home monitoring (e.g. suffering from anxiety or depression)
✕. Refuse to comply with dietary prescription
✕. Patients who participate in other study at the same time
✕. Patients who have participated in another research study involving an investigational product in the past 12 weeks preceding enrollment.
✕. Planning for kidney transplant over the study duration.
✕. Female patients who are pregnant, lactating or planning a pregnancy during the course of the trial.
✕. Participants who are receiving nutritional support (i.e. enteral and intra-venous route).