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

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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.

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