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

LANDMARK 3 2013.

Study characteristics
Methods

  • Study design: prospective RCT

  • Study dates: February 2008 to March 2010

  • Study duration: 12 months
Participants

  • Country: Australia

  • Setting: single centre; hospital outpatient clinic

  • Inclusion criteria: 18 to 75 years; moderate CKD (eGFR 25 to 60 mL/min/1.73 m²); had one or more uncontrolled cardiovascular risk factors such as BP exceeding target; overweight (BMI > 25 kg/m²); poor diabetic control (HbA1c > 7%), or lipids exceeding target

  • Number: lifestyle intervention group (36); control group (36)

  • Mean age ± SD (years): lifestyle intervention group (60.2 ± 9.7); control group (62.0 ± 8.4)

  • Sex (M/F): lifestyle intervention group (24/12), control group (21/15)

  • Baseline characteristics

    • Nationality: not reported

    • Ethnicity: not reported

    • Mean baseline BMI ± SD (kg/m²): lifestyle intervention group (32.5 ± 6.8); control group (33.0 ± 8.0)

    • Stage of CKD: stages 3 and 4

    • Mean baseline eGFR ± SD (mL/min/1.73 m²): lifestyle intervention group (38.4 ± 8.8); control group (39.4 ± 8.9)

    • Mean baseline peripheral SBP ± SD (mmHg): lifestyle intervention group (128.8 ± 16.1); control group (132.3 ± 12.0)

    • Mean baseline peripheral DBP ± SD (mmHg): lifestyle intervention group (74.9 ± 8.1); control group (71.1 ± 9.0)

    • Mean baseline energy intake (kcal/kg/day): not reported

    • Comorbid conditions: type 2 diabetes; coronary heart disease; hypertension

  • Exclusion criteria: intervention for or symptomatic coronary artery disease (within 3 months); current heart failure (NYHA class III and IV) or significant valvular heart disease; pregnant or planning to become pregnant; life expectancy or anticipated time to dialysis or transplant < 6 months
Interventions

  • Intervention type classification: lifestyle

  • Weight loss intervention/s used: physical activity + dietary + behaviour change


Lifestyle intervention group

  • In addition to standard care, participants received cardiovascular risk management provided by a multidisciplinary clinic (including a CKD nurse practitioner, dietitian, exercise physiologist, diabetic educator, psychologist, and social worker), exercise training and a lifestyle intervention

  • Exercise training involved 150 minutes of moderate intensity exercise/week, with 8 weeks of 2 to 3 gym sessions/week supervised by an accredited clinical exercise physiologist

  • The lifestyle intervention involved 4 weeks of group behaviour and lifestyle modification facilitated by a dietitian and psychologist. The program focused on sustainable diet and behaviour change to assist with weight loss


Standard care (control group)

  • Received usual standard clinic care, which included review by a nephrologist, recommended lifestyle modification but no specific information or education, and referral to an allied health professional on an ad hoc basis


Co‐interventions

  • None reported
Outcomes

  • Weight loss (kg)

  • BMI (kg/m²)

  • SCr (µmol/L)

  • Fasting glucose (mmol/L)

  • Triglycerides (mmol/L)

  • Total cholesterol (mmol/L)

  • HDL cholesterol (mmol/L

  • LDL cholesterol (mmol/L)

  • HbA1c (%): diabetics only

  • Adherence to treatment
Notes

  • Founding source: National Health and Medical Research Council–funded Centre for Clinical Research Excellence–Vascular and Metabolic Health of the University of Queensland, and Department of Nephrology at Princess Alexandra Hospital

  • Trial registration: The Australian New Zealand Clinical Trials Registry (ANZCTR) No. 12608000337370

  • Additional data: Appendix 3

  • Possible conflicts of interest for study author: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote "Patients were assigned to either the lifestyle intervention group or to the usual care control group in a 1:1 ratio using a computer random assignment program."
Allocation concealment (selection bias) Unclear risk Insufficient information provided to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk The study was an open label study ‐ participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information provided to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Low risk < 15% attrition rates across each groups with similar reasons for withdrawal
Selective reporting (reporting bias) Low risk Authors appear to report on what they intended to report on as described in the study aims
Other bias Unclear risk The study appears to be free of other sources of bias