A Low-Intensity Mobile Health Intervention With and Without Health Counseling for Persons With Type 2 Diabetes, Part 1: Baseline and Short-Term Results From a Randomized Controlled Trial in the Norwegian Part of RENEWING HEALTH

BACKGROUND: Self-management support for people with type 2 diabetes is essential in diabetes care. Thus, mobile health technology with or without low-intensity theory-based health counseling could become an important tool for promoting self-management. OBJECTIVES: The aim was to evaluate whether the introduction of technology-supported self-management using the Few Touch Application (FTA) diabetes diary with or without health counseling improved glycated hemoglobin (HbA(1c)) levels, self-management, behavioral change, and health-related quality of life, and to describe the sociodemographic, clinical, and lifestyle characteristics of the participants after 4 months. METHODS: A 3-armed randomized controlled trial was conducted in Norway during 2011-2013. In the 2 intervention groups, participants were given a mobile phone for 1 year, which provided access to the FTA diary, a self-help tool that recorded 5 elements: blood glucose, food habits, physical activity, personal goal setting, and a look-up system for diabetes information. One of the intervention groups was also offered theory-based health counseling with a specialist diabetes nurse by telephone for 4 months from baseline. Both intervention groups and the control group were provided usual care according to the national guidelines. Adults with type 2 diabetes and HbA(1c) ≥7.1% were included (N=151). There were 3 assessment points: baseline, 4 months, and 1 year. We report the short-term findings after 4 months. HbA(1c) was the primary outcome and the secondary outcomes were self-management (Health Education Impact Questionnaire, heiQ), behavioral change (diet and physical activity), and health-related quality of life (SF-36 questionnaire). The data were analyzed using univariate methods (ANOVA), multivariate linear, and logistic regression. RESULTS: Data were analyzed from 124 individuals (attrition rate was 18%). The groups were well balanced at baseline. There were no differences in HbA(1c) between groups after 4 months, but there was a decline in all groups. There were changes in self-management measured using the health service navigation item in the heiQ, with improvements in the FTA group compared to the control group (P=.01) and in the FTA with health counseling group compared with both other groups (P=.04). This may indicate an improvement in the ability of patients to communicate health needs to their health care providers. Furthermore, the FTA group reported higher scores for skill and technique acquisition at relieving symptoms compared to the control group (P=.02). There were no significant changes in any of the domains of the SF-36. CONCLUSIONS: The primary outcome, HbA(1c), did not differ between groups after 4 months. Both of the intervention groups had significantly better scores than the control group for health service navigation and the FTA group also exhibited improved skill and technique acquisition.