Currently submitted to: Journal of Medical Internet Research
Date Submitted: Mar 12, 2024
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy of a mHealth Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: The Greenhabit Randomized Controlled Trial
ABSTRACT
Background:
Improving self-management approaches to healthcare is a promising strategy to empower patients with type 2 diabetes (T2D) to enhance self-care.
Objective:
To assess whether the use of the Greenhabit (mHealth) Behavioural Treatment can improve T2D outcomes compared to standard treatment.
Methods:
A randomized, parallel group, single-blind, controlled trial was conducted in 123 participants with T2D, who were face-to-face recruited and randomly assigned to one of two groups: 1. Intervention group, instructed to use the Greenhabit mobile application and following standard recommendations, and 2. Control group, following standard recommendations. Nutritional and anthropometric data and blood and urine samples were collected at baseline and after 6- and 12-weeks of follow-up. Quality of life, work-life, and social environment questionnaires were also collected at the baseline and final visits. The primary outcome was HbA1c. Repeated-measures ANOVA was used to compare changes (first baseline and 6-weeks and after baseline and 12-weeks) and the 2 intervention groups. Analysis of covariance was used to assess changes after 6- and 12-weeks adjusted for the baseline levels of each variable. The multiple contrasts were adjusted by a Bonferroni post hoc test.
Results:
Both intervention (n=50) and control (n=53) groups disclosed significant reductions in HbA1c concentrations after 6 and 12 weeks (mean change in intervention group -0.4%, P<.001 vs -0.3% in control group, P<.05). At 12 weeks participants in the intervention group also presented significant reductions in systolic and diastolic blood pressures (mean change -4.6 and -2.5 mmHg, respectively), body weight (mean change -0.8 kg), body mass index (mean change -0.3 kg/m2), waist perimeter (mean change -1.1 cm) and triglyceride concentration (mean change -18.7 mg/dL), as well as a significant increase in HDL-cholesterol concentrations (mean change 2 mg/dL), P<.05 all. Finally, participants allocated to the intervention group notably improved in 3 out of the 5 elements of balance: Positivity, Social environment, and Work life balance.
Conclusions:
A 12-week intervention with the Greenhabit Behavioral treatment mobile health application had beneficial effects on T2D outcomes, such as HbA1c, and reduced the burden of cardiovascular risk factors. Clinical Trial: ISRCTN 13456652
Citation
