title: 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.
abstract: 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.
  
  
  OBJECTIVE
  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 (HbA1c) 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 HbA1c ≥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. HbA1c 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 HbA1c 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, HbA1c, 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.
authors.affiliation: Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway. Astrid.Torbjornsen@hioa.no.
authors.forename: Astrid
authors.identifier: http://orcid.org/0000-0003-2385-2452
authors.initials: A
authors.lastname: Torbjørnsen
authors.forename: Anne Karen
authors.identifier: http://orcid.org/0000-0003-0304-7800
authors.initials: AK
authors.lastname: Jenum
authors.forename: Milada Cvancarova
authors.identifier: http://orcid.org/0000-0001-8947-8649
authors.initials: MC
authors.lastname: Småstuen
authors.forename: Eirik
authors.identifier: http://orcid.org/0000-0002-9520-1408
authors.initials: E
authors.lastname: Arsand
authors.forename: Heidi
authors.identifier: http://orcid.org/0000-0003-1314-7813
authors.initials: H
authors.lastname: Holmen
authors.forename: Astrid Klopstad
authors.identifier: http://orcid.org/0000-0002-5545-5710
authors.initials: AK
authors.lastname: Wahl
authors.forename: Lis
authors.identifier: http://orcid.org/0000-0003-1850-7902
authors.initials: L
authors.lastname: Ribu
keywords: complex intervention; counseling; diabetes mellitus, type 2; life style; mHealth; mobile apps; quality of life; randomized controlled trials; self-care; telemedicine