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

Leehey 2016.

Study characteristics
Methods

  • Study design: parallel RCT (48 patients assessed for eligibility; 36 randomised)

  • Recruitment: enrolment start and finish date not reported

  • Study duration: intervention 52 weeks (follow‐up 52 weeks)
Participants

  • Country: USA

  • Setting: single centre, hospital outpatient clinic

  • Inclusion criteria: type 2 diabetes mellitus, obesity (BMI > 30 kg/m²) and CKD stages 2 to 4 with proteinuria (urine PCR > 200 mg/g) for at least 3 months

  • Number: intervention group (14); control group (18)

  • Mean age ± SD (years): intervention group (65.4 ± 8.7); control group (66.6 ± 7.5)

  • Sex (M/F): all males.

  • Baseline characteristics

    • Nationality: American

    • Ethnicity: Caucasian (19); African American (13); Hispanic origin (4)

    • Mean baseline BMI (kg/m²): intervention group (36.2 ± 4.8); control group (37.4 ± 4.2)

    • Stage of CKD: stages 2 to 4

    • Mean baseline eGFR ± SD (mL/min/1.73 m²): intervention group (40.9 ± 18.1); control group (38.9 ± 20.3)

    • Mean baseline SBP ± SD (mmHg): not measured

    • Mean baseline DBP ± SD (mmHg): not measured

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

    • Comorbid conditions: type 2 diabetes mellitus (100%)

  • Exclusion criteria: CVD precluding participation in exercise program; moderate to severe congestive heart failure (NYHA class II‐IV); moderate to severe chronic obstructive pulmonary disease; history of cerebrovascular accident with cognitive impairment; kidney transplant; inability to walk on a treadmill
Interventions

  • Intervention type classification: lifestyle

  • Weight loss intervention/s used: exercise (aerobic and resistance) + dietary


Intervention group (exercise + diet)

  • A kidney dietitian devised a diet with a 200 to 250 kcal deficit from the individuals estimated energy needs. Participants received a nutritional counselling session at baseline with 9 follow‐up phone calls during the study. Individualised nutritional counselling with 200 to 250 kcal energy deficit plus 3 times/week supervised exercise 60 min cardiovascular and 30 min resistance training 12 weeks, then 40 weeks home exercise 3 x 60 min or 6 x 30min sessions. Participants received nutritionally counselling and underwent a supervised exercise program. Exercise program consisted of a 12 week (3 days/week) supervised program of ~60 minute aerobic session (interval training on treadmill, elliptical trainer, and cycle ergometer) and ~ 20 minutes to 30 minutes of resistance training (lower body exercises using elastic bands, hand‐held weights, or weight machine) followed by 40 weeks of home exercise. Home exercise consisted of exercise as 60 minutes thrice weekly or 30 minutes 6 times/week. Participants received weekly phone calls and were encouraged to meet with their trainer on a monthly basis


Control group (diet alone)

  • A kidney dietitian devised a diet with a 200 to 250 kcal deficit from the individuals estimated energy needs. Participants received a nutritional counselling session at baseline with 9 follow‐up phone calls during the study. Participants underwent medical care by their usual physicians, with medications adjusted according to standards of medical practice at the medical centre


Co‐interventions

  • Referral to MOVE program, a lifestyle modification program, ACEi or ARB, aspirin therapy and statin therapy unless contraindicated
Outcomes

  • BMI (kg/m²)

  • Body composition: body fat (%), lean weight (kg), fat weight (kg)

  • Proteinuria (mg/g)

  • Albuminuria (mg/g)

  • SBP (mmHg)

  • HbA1c (%)

  • Total cholesterol (mg/dL)

  • LDL cholesterol (mg/dL)

  • HDL cholesterol (mg/dL)

  • Triglycerides (mg/dL)

  • Inflammation: C‐reactive protein (mg/dL)

  • Adherence to treatment

  • Health‐related quality of life (SF‐36 Health Survey and CES‐D)

  • Adverse patient outcomes associated with each weight loss intervention
Notes

  • Founding source: Department of Veterans Affairs, USA

  • Additional data: requested see Appendix 3

  • Trial registration: ClinicalTrials.gov (NCT01036490)

  • 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 randomised using a computer generated permuted block scheme"
Allocation concealment (selection bias) Low risk Insufficient information to permit judgement ‐ not reported if allocation was concealed
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants not blinded, personnel undertaking intervention not blinded
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Study personnel supervising testing were blinded to group assignment."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Study appears free of other biases. Study underpowered ‐ didn't reach target sample size to detect treatment effect looking for