Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial.
Schmid-Mohler, G. et alTransplantation Direct 2019 Nov 15;5(12):e507
Aims
To evaluate the effect of an 8-month behavioural intervention which aims to prevent weight gain in kidney and kidney-pancreas transplant recipients.
Interventions
Both groups received a 45-60 minute nurse delivered educational intervention. The behavioural group also received 7-8 sessions over eight months focusing on behaviour to achieve or maintain normal weight and on integrating physical activity in daily life.
Participants
123 adult kidney and kidney –pancreas transplant recipients who received their transplant no more than 6 weeks ago.
Outcomes
The primary outcome was change in BMI between baseline and 8 months. Secondary outcomes were BMI change between baseline and 12 months, and changes in lean tissue mass, waist-hip ratio, self-reported physical activity and number of steps.
Follow-up
12 months
CET Conclusions
The randomised controlled trial tested the effect of an 8-month behavioural intervention on BMI change in adult kidney and kidney-pancreas transplant recipients who started within 6 weeks posttransplant. The sample size calculation was based on data from a pilot study and showed that 128 patients would achieve 80% power. Using envelopes, 123 patients were randomised to a behavioural intervention or usual care. Usual care consisted of one educational intervention whilst the behavioural intervention consisted of 7-8 face-to-face and telephone interventions. The difference in BMI change at 8 and 12 months was not significant between groups. There were also no significant differences in BMI change between groups regarding body composition, any of the measures of physical activity or self-report physical activity. The authors conclude that both interventions resulted in good weight management and suggest that future research should focus on investigating which patients would benefit most from complex weight control interventions.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT02282124