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. 2021 Mar 30;2021(3):CD013119. doi: 10.1002/14651858.CD013119.pub2

Orazio 2011.

Study characteristics
Methods

  • Study design: parallel RCT

  • Recruitment: May 2003 to February 2007

  • Study duration: 5 months (follow‐up 2 years)
Participants

  • Country: Australia

  • Setting: single‐centre; hospital outpatient department

  • Inclusion criteria: ≥ 6 months post kidney transplant; functioning and stable transplant; attend regular follow‐up every 2 or 3 months

  • Number: intervention group (56; 41 overweight or obese); control group (46; 38 overweight or obese)

  • Mean age ± SD (years): intervention group (54.9 ± 9.9) control group (54.7 ± 11.8)

  • Sex (M/F): intervention group (33/23); control group (29/17)

  • Baseline characteristics

    • Nationality: not reported

    • Ethnicity: not reported

    • Mean baseline BMI (kg/m²): intervention group (29 ± 5); control group (29 ± 6)

    • Stage of CKD: transplant recipients

    • Mean baseline eGFR ± SD (mL/min/1.73 m²): intervention group (54 ± 20); control group (48 ± 17)

    • Median baseline SBP, range (mmHg): intervention group (135, 105 to 178); control group (131, 100 to 171)

    • Median baseline DBP, range (mmHg): intervention group (81, 56 to 107); control group )79, 50 to 100)

    • Median baseline energy intake, range) (kJ): intervention group (8334, 5502 to 12,031); control group (8539, 6646 to 12,418)

    • Comorbid conditions: type 2 diabetes mellitus (47%)

  • Exclusion criteria: not reported
Interventions

  • Intervention type classification: lifestyle

  • Weight loss intervention/s used: dietary + exercise


Intervention group (lifestyle group)

  • Individualised dietary advice was provided to participants for the duration of the trial. A Mediterranean style (< 30% total energy from fat), low glycaemic index with an energy deficit of 500 kcal/day to promote weight loss was recommended.

  • Physical activity advice was provided participants in line with the Australian National Physical Activity recommendations of 150 minutes of accumulated physical activity each week.

  • The Transtheoretical Model of Health Behaviour Change or Stage of Change Model was a component underpinning the lifestyle intervention. Study manual with dietary information and lifestyle information, food models and pictures was used to teach participants. Individualised dietary advice was provided to participants for the duration of the trial. Physical activity ‐ advice to achieve 150 minutes of accumulated physical activity per week. The intervention was delivered by a multi‐disciplinary team (dietitian, nephrologist, nurse, and endocrinologist).The Transtheoretical Model of Health Behaviour Change or Stage of Change model was a used to provide a framework for goal setting.


Control group

  • Received usual standard care


Co‐interventions

  • None reported
Outcomes

  • Body weight (kg)

  • BMI (kg/m²)

  • Waist circumference (cm)

  • Waist‐to‐hip ratio (units)

  • SBP (mmHg)

  • DBP (mmHg)

  • Total cholesterol (mmol/L)

  • LDL cholesterol (mmol/L)

  • HDL cholesterol (mmol/L)

  • Triglycerides (mmol/L)

  • Fasting blood glucose (mmol/L)

  • HbA1c (mmol/L)

  • Dietary intake (energy intake kJ/day)

  • Physical activity behaviours (The Physical Activity Statewide Questionnaire)
Notes

  • Founding source: Allied Health Research Scheme from Queensland Health and an Allied Health Research Scholarship from the Princess Alexandra Hospital Foundation, Brisbane

  • Trial registration: not reported

  • Possible conflicts of interest for study author: not declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Insufficient information to permit judgement ‐ participants unlikely to be not blinded
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Number of participants who completed the study were not reported
Selective reporting (reporting bias) Unclear risk No protocol published. Insufficient information detailing whether treatment outcomes are reported as planned
Other bias Low risk Study appears free of other biases