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. 2019 Aug 6;2019(8):CD012379. doi: 10.1002/14651858.CD012379.pub2

BALANCEWise‐PD 2011.

Methods
  • Study design: parallel RCT; 30 peritoneal dialysis patients assessed for eligibility; 26 randomised

  • Study duration: 16 weeks

  • Study follow‐up: 16 weeks

Participants
  • Country: USA

  • Setting: multicentre (3 sites)

  • Dialysis‐dependent CKD

  • Number (randomised/completed): intervention group (13/11); control group (13/10)

  • Mean age ± SD (years): intervention group (51.7 ± 19.8); control group (not reported)

  • Sex (M/F): intervention group (7/6); control group (not reported)

  • Race: intervention group (8/13 minority race); control group (not reported)

  • Exclusion criteria: could not read or write; planned to move out of area or change dialysis centres during the study period

Interventions
  • Intervention type classification: self‐monitoring

  • eHealth intervention used: PDA application


Intervention group
  • PDA‐based diet self‐monitoring

    • PDA‐based dietary self‐monitoring using a nutrient database with individual nutrient and calorie goals as per renal dietitian. Electronic food diary logs uploaded when meeting face‐to‐face

    • 16 weeks of dietary counselling based on Social Cognitive Theory. Primarily focused on moderating dietary sodium intake, additional counselling if electronic record suggested inadequate protein or caloric intake or laboratory markers showing hyperphosphataemia or hyperkalaemia. Counselling was conducted face‐to‐face or via telephone and occurred twice a week during weeks 1 to 6, weekly during weeks 7 to 12, and every other week for weeks 13 to 16


Control group
  • Not reported

Outcomes
  • Adherence to diet self‐monitoring (intervention group only)

    • Number of meals entered

Notes
  • Funding source: work was supported by the following grants: Paul Teschan Research Foundation, NIH/NIDDK/DK‐R21DK067181, NIH/NCRR/CTSA‐UL1‐RR024153, and NIH/NCRR/GCRC‐M01‐ RR000056

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study described as randomised, method of random sequence generation not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Participants could not have been blinded
Blinding of participants and personnel (performance bias) 
 Blinding of personnel High risk The intervention and attention control activities were conducted by study staff
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Number of meals entered was an objective measure
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Low risk No subjective outcomes were measured
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) High risk Primary outcomes were not reported
Other bias Unclear risk Insufficient information to permit judgement