Health literacy and exercise-focused interventions on clinical measurements in Chinese diabetes patients: A cluster randomized controlled trial

Abstract

BackgroundThe diabetes patients in China have low health literacy and low levels of physical activities which may result in the poor glycemic control and other clinical outcomes. This study is designed to evaluate the effectiveness of health literacy and exercise-focused interventions on clinical outcomes among Chinese patients with type 2 diabetes (T2DM).MethodsIn this cluster randomized controlled trial, 799 T2DM patients with the most recent A1c ≥ 7·5% (58 mmol/mol, or fasting glucose level ≥10 mmol/L) were recruited from 35 clinics in 8 communities in Shanghai, China, and randomized into one standard care (control) arm and three intervention arms receiving interventions focused on health literacy, exercise or both. A1c (primary outcome), blood pressure and lipids (secondary outcomes) were measured at baseline, 3-, 6-, 12-months of intervention period and 12-months after completion of the interventions. This trial is registered with the International Standard RCT Number Register, number ISRCTN76130594.FindingsThe three intervention groups had more reductions in A1c than the control group, with 0·90% reduction in the health literacy, 0·83% in the exercise and 0·54% in the comprehensive group at 12-months (p<0·001) and these improvements remained even after a 1-year follow-up period post intervention. The risk of suboptimal A1c (≥7·0% or 53 mmol/mol) was also significantly lower in three intervention groups than control group at each follow-up visit, with adjusted risk ratios (RR) ranging from 0.06 to 0.16. However, the control group has greater reductions in low-density lipoprotein (LDL) than the health literacy group from baseline to 12-months (β=0·55, p<0·0001) and from baseline to 24-months (β=0·62, p<0·0001). A higher risk of abnormal LDL was also observed for the health literacy group at 12-months [adjusted risk ratio (RR): 2·22, 95%CI: 1·11-4·44] and 24-months [adjusted risk ratio (RR): 2·37, 95%CI: 1·16-4·87] compared to the control group. No significant benefits in systolic blood pressure (SBP), diastolic blood pressure (DBP) and low-density lipoprotein (HDL) were observed from the interventions compared to the usual care.InterpretationThe health literacy and exercise interventions result in significant improvements in A1c. However, no significant benefits in blood pressure and lipids control were observed. These effective interventions may have potential of scaling up in China and other countries to help diabetes patients manage their blood glucose levels.FundingThis Study was supported by the China Medical Board (CMB) Open Competition Project (No.13-159) and the Social Science Fund of China National Ministry of Education (No.14YJAZH092).

Health system interventions for adults with type 2 diabetes in low- and middle-income countries: A systematic review and meta-analysis

“…Diabetes education or support alone. Nine studies involved health workers primarily implementing diabetes education or support without additional services [32,39,40,43,46,49,53,54,56]. We defined these interventions as diabetes education or support alone.…”

“…Six of the studies primarily involved in-person delivery [32,40,43,46,49,56], and 3 studies delivered the intervention in group format [46,49,56]. The health workers in these studies varied between and within studies and included peers [49,53,56], community health workers [43,46,53], nurses [32,39,40,53,54], psychologists [32], and physicians [32,39,54]. Face-to-face encounters were supplemented with telephone calls in 2 studies [32,54] and by computerassisted instruction in another study [40].…”

“…The health workers in these studies varied between and within studies and included peers [49,53,56], community health workers [43,46,53], nurses [32,39,40,53,54], psychologists [32], and physicians [32,39,54]. Face-to-face encounters were supplemented with telephone calls in 2 studies [32,54] and by computerassisted instruction in another study [40]. Motivational interviewing techniques were incorporated in 2 studies [32,46].…”

“…The intervention arms were combined in the study by Anzaldo-Campos and colleagues [59]. Only the health literacy intervention arm was included in the study by Wang and colleagues [54]. The proportion of participants from low-and middle-income countries was inferred to be 60% in the study by Reutens and colleagues [66].…”

Building a House of Skills—A Study of Functional Health Literacy and Numeracy among Patients with Type 2 Diabetes in Hungary

“…Although the number of national and international studies examining this complex phenomenon has been increasing, there are still relatively few studies on disease-specific FHL [23]. Furthermore, little is known about FHL levels and their impact on diabetes outcomes (e.g., knowledge, self-care, glycemic control) [24,25], maybe due to the complexity of the phenomenon, which is highlighted by the quantitative studies in the past 5 years. According to a meta-analysis published in 2019, HL prevalence studies among patients with T2DM were done mostly in the USA and these results mainly date back to the early 2000's [11].…”