Trial reportJournal of primary care & community health
Self-Reported Depression, Anxiety, Stress, Health-Related Quality of Life, and Diabetes Distress During a 2-Year Pedometer-Based Physical Activity Intervention in Prediabetes and Type 2 Diabetes: Secondary Outcomes of a Randomized Controlled Trial.
Trial report in Journal of primary care & community health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundRegular physical activity is essential for preventing and managing type 2 diabetes. This study evaluates self-reported outcomes including depression, anxiety, stress, diabetes distress, and health-related quality of life during a 2-year pedometer-based intervention, with or without physical activity counseling, in people with prediabetes or type 2 diabetes.
methodsThis study was a 3-armed parallel randomized controlled trial conducted in primary healthcare, involving people with prediabetes or type 2 diabetes. The 3 arms were: a multi-component intervention (self-monitoring of steps with counseling support), a single-component intervention (self-monitoring of steps without counseling support), and a control group (standard care). Secondary outcomes were measured using questionnaires for self-reported depression and anxiety (the Hospital Anxiety and Depression Scale [HADS]), stress (Perceived Stress Scale [PSS]), health-related quality of life (EuroQol, [EQ-5D 3L, and EQ-VAS] ), and diabetes distress (The Problem Areas in Diabetes questionnaire, [Swe-PAID-20]), at baseline and at months 3, 6, 12, 18, and 24. Intervention effects were evaluated by a robust linear mixed model.
resultsIn total, 188 patients (n = 64, 59, 65 in the respective group) were included. The mean (SD) age was 64.1 (7.7) years, 21% had prediabetes, 40% were female, and HbA1c was 49.9 (11.4) mmol/mol. The retention rate was approximately 91% of participants in the first year and 81% at the end of the second year. There were no significant within-group changes in self-reported outcomes from baseline up to 24 months. Moreover, there were no significant differences in outcomes between the interventions and control group at any time in any outcome.
conclusionThis 2-year, pedometer-based physical activity intervention, despite its effectiveness for other outcomes in previous studies, is likely insufficient on its own to improve psychological well-being or reduce diabetes distress in a primary care population with prediabetes or type 2 diabetes with generally well-managed mental health at baseline. The study offers methodological insights that can guide future research. It highlights the complexity of assessing mental health outcomes within practical, low-intensity physical activity interventions.
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