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Digital messaging to support control for type 2 diabetes (StAR2D): a multicentre randomised controlled trial.
Farmer, A, Bobrow, K, Leon, N, Williams, N, Phiri, E, Namadingo, H, Cooper, S, Prince, J, Crampin, A, Besada, D, et al
BMC public health. 2021;21(1):1907
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Plain language summary
Many individuals with type 2 diabetes find it challenging to adhere to treatments possibly due to lack of support. Text messaging has been shown to be effective for treatment adherence in various parts of the world, yet it is unclear on its effect in Malawi and sub-Saharan Africa. The aim of this randomised control trial of 1186 individuals was to determine the effect of motivational and educational text messages three to four times per week for 12 months on treatment success. The results showed that SMS text messages resulted in improved blood pressure and achievement of treatment goals, yet no effect on blood sugar control. It was concluded that text messaging without other support from health care professionals may be inadequate for the self-management of type 2 diabetes. This study could be used by health care professionals to understand that there are additional support strategies for individuals with type 2 diabetes, yet these should be secondary to the input from professionals.
Abstract
BACKGROUND Failure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes. METHODS StAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals. RESULTS The trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (- 0.08% (- 0.31 to 0.16) (IFCC - 0.82 mmol/mol (- 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was - 0.71% (- 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful. CONCLUSIONS Whilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes. TRIAL REGISTRATION Trial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808.
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Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial.
Vargas-Ortiz, K, Lira-Mendiola, G, Gómez-Navarro, CM, Padilla-Estrada, K, Angulo-Romero, F, Hernández-Márquez, JM, Villa-Martínez, AK, González-Mena, JN, Macías-Cervantes, MH, Reyes-Escogido, ML, et al
BMC public health. 2020;20(1):97
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In individuals at high risk of type 2 diabetes, lifestyle interventions rather than medication have been more successful in preventing development of the disease, however the benefits of lifestyle strategies diminishes over time due to possible adherence issues. Prolonged lifestyle changes may be affected by lack of family support, but research on family support during lifestyle changes in individuals prior to diabetes is lacking. This parallel randomised control trial of 122 patients with prediabetes and 101 of their family members aimed to assess the impact of family supported diet and exercise changes compared to self-motivation on individuals with prediabetes. At 6 months, body measurements and markers of prediabetes improved in both groups. Lipids were significantly improved in the group with family support compared to having no support. At 12 months there were a high number of dropouts due to lack of patient interest. Benefits shown at 6 months in both groups were only maintained or improved upon with family support and the lipid profile of the individual intervention group actually worsened in comparison to when participants entered the trial. After 12 months the incidence rate of type 2 diabetes was similar in both groups. Individuals with prediabetes who had family support whilst undergoing a diet and exercise regime were more successful at maintaining improvements of factors contributing to diabetes, compared to individuals without support. However this did not affect the occurrence of type 2 diabetes. Clinicians could use this paper to communicate the importance of family support during lifestyle changes in patients at high risk of developing type 2 diabetes, although close monitoring may be required to ensure compliance.
Abstract
BACKGROUND Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients´ family. The aim of this study was to compare the impact of an interdisciplinary family (FI) Vs individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic β-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families' metabolic risk. METHODS Randomized Clinical Trial (RCT) to compare the impact of FI and II on IR and pancreatic β-cell function in subjects with prediabetes. There were 122 subjects with prediabetes (and 101 family members) randomized to FI or II. Data were collected in 2015-2016 and analyzed in 2017-2018. FI group had the support of their family members, who also received personalized diet and exercise recommendations; patients and their family members attended monthly a lifestyle enhancement program. II group received personalized diet and exercise recommendations. The follow-up was for 12 months. Glucose, IR, pancreatic β-cell function and secondary outcomes (body composition and lipid profile) were assessed at baseline, 6 and 12 months. RESULTS FI group improved area under the glucose curve (AUC) (from 18,597 ± 2611 to 17,237 ± 2792, p = 0.004) and the Matsuda index (from 3.5 ± 2.3 to 4.7 ± 3.5, p = 0.05) at 12 months. II group improved Disposition Index (from 1.5 ± 0.4 to 1.9 ± 0.73, p < .0001) at 12 months. The improvements achieved in weight and lipids at 6 months, were lost in II group at 12 moths, whereas in FI persisted. Adherence up to 12 months was not different between the study groups (FI 56% Vs II 60%). CONCLUSIONS FI intervention was more effective by improving glucose AUC, insulin sensitivity and lipid profile, besides that, metabolic risk in family members of the FI group was maintained, while the risk of II group was increased. TRIAL REGISTRATION This study was retrospectively registered at clinicaltrials.gov on December 15, 2015 (NTC026365646).