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

Woolf 2017.

Study characteristics
Methods
  • Study design: pilot RCT

  • Recruitment: enrolment start and finish date not reported

  • Study duration: 6 months

Participants
  • Country: USA

  • Setting: not reported

  • Inclusion criteria: obese or overweight patients with type 2 diabetes and CKD

  • Number: Social Cognitive Theory‐based lifestyle intervention (7); standard behaviour treatment (7)

  • Mean age ± SD: 65.9 ± 9.7 years

  • Sex (% male): 71.4%

  • Baseline characteristics

    • Nationality: not reported

    • Ethnicity: 71.4% of participants were white

    • Mean baseline BMI ± SD: 34.8 ± 5.4 kg/m²

    • Stage of CKD: not reported

    • Mean baseline eGFR ± SD (mL/min/1.73 m²): not reported

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

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

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

    • Comorbid conditions: not reported

  • Exclusion criteria: not reported

Interventions
  • Intervention type classification: lifestyle

  • Weight loss intervention/s used: behavioural


Intervention group
  • Social Cognitive Theory‐based lifestyle intervention: group was provided with an iPad to participate in live WebEx sessions with a registered dietitian, access to MyNetDiary (an online tool to log dietary intake, exercise, and body weight) and email feedback from a registered dietitian weekly for the first month and then biweekly for 6 months


Control group
  • Standard behaviour treatment group: no further information on what the group received was reported


Co‐interventions
  • Nil reported

Outcomes
  • Weight loss (%)

Notes
  • Founding source: NIH K24 NR01226 and NIH R01 DK100492 (PI MA Sevick)

  • Trial registration: not reported

  • Possible conflicts of interest for study author: Not declared (no statement provided).

  • Abstract‐only publication

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 Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
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 Insufficient information to permit judgement

ACEi ‐ angiotensin‐converting enzyme inhibitors; ACR ‐ albumin‐to‐creatinine ratio; ALT ‐ alanine aminotransferase; ARB ‐ angiotensin receptor blocker; AST ‐ aspartate aminotransferase; BMI ‐ body mass index; BP ‐ blood pressure; CKD ‐ chronic kidney disease; CrCl ‐ creatinine clearance; CVD ‐ cardiovascular disease; DBP ‐ diastolic blood pressure; (e)GFR ‐ (estimated) glomerular filtration rate; Hb ‐ haemoglobin; HbA1c ‐ haemoglobin A1c; HD ‐ haemodialysis; HDL ‐ high‐density lipoprotein; HRQoL ‐ health‐related quality of life; IGAN ‐ Ig A nephropathy; IQR ‐ interquartile range; LDL ‐ low‐density lipoprotein; NSAID ‐ nonsteroidal anti‐inflammatory drug; NYHA ‐ New York Heart Association; PCR ‐ protein:creatinine ratio; RCT ‐ randomised controlled trial; SBP ‐ systolic blood pressure; SCr ‐ serum creatinine