The impact of a 6-month dietary counseling intervention on quality of life in individuals with type 2 diabetes: A secondary analysis of a randomized controlled trial

Background and aims Type 2 diabetes mellitus (T2DM) negatively impacts quality of life. We examined the effect of a 6-month dietary counseling intervention on quality of life in Dutch individuals with T2DM. Methods This secondary analysis of data from a randomized controlled trial includes 121 individuals with non-insulin-dependent T2DM randomized to 6 months of dietary counseling or to standard care. This study focuses on the between-group differences over time in the physical (PCS) and mental (MCS) component summary scores of the 36-item Short-Form Health Survey and the between-group differences over time in the 17-item Positive Health questionnaire scores. Data were analyzed using multiple linear regression. Results Of the 121 participants, 67.8 % was male, mean age was 66.9 ± 8.7 years, and median T2DM duration was 8.0 [4.0, 18.0] years. Baseline PCS and MCS indicated relatively good quality of life. Effects on PCS (adjusted mean difference (AMD) = 1.1, 95 % CI [-1.5; 3.8]) and MCS (AMD = −1.5, 95 % CI [-4.1; 1.1]) were not statistically significant between groups. There was no effect on Positive Health (AMD = 0.0, 95 % CI [-0.3; 0.5]). Conclusion Dietary counseling for 6 months did not affect quality of life in individuals with T2DM compared to standard care. Registration number of clinical trial The study protocol was approved by the Medical Research Ethics Committee Oost-Nederland in August 2022 with protocol number NL80697.091.22. The trial is registered at the International Clinical Trials Registry Platform (ICTRP) as NL-OMON51759 and at clinicaltrials.gov with registration number NCT05666843.