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

HHK 2018.

Study name Lifestyle management of CKD in obese diabetic patients: The Healthy Hearts and Kidneys (HHK) study
Methods Design of a 2 x 2 factorial RCT of technology‐supported self‐monitoring and social cognitive theory‐based counselling to engage overweight people with diabetes and CKD in multiple lifestyle changes
Participants Individuals with type 2 diabetes mellitus and evidence of CKD aged ≥ 40 years, who are overweight/obese BMI ≥ 27.0 kg/m²
Interventions Participants will be randomised to 1 of 4 groups

  1. Usual care (UC)

  2. Social Cognitive Theory‐based group counselling (SCT)

  3. Mobile self‐monitoring with tailored feedback and counselling (MONITORING)

  4. Combination of SCT plus MONITORING conditions (COMBINED)
Outcomes Primary outcomes

  • Weight reduction

  • Urinary sodium excretion

  • Serum phosphorus


Secondary outcomes

  • Physical activity

  • BP

  • Fasting lipids

  • Medication requirements

  • Pulse wave velocity


Measurements will occur at baseline, 6 and 12 months
Starting date October 2014
Contact information Mary Ann Sevick
mary.sevick@nyumc.org
Notes Clinical trials last updated on 14 July 2020. Recruitment completed