Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial

BackgroundEnhancing self-management in health care through digital tools is a promising strategy to empower patients with type 2 diabetes (T2D) to improve self-care. ObjectiveThis study evaluates whether the Greenhabit (mobile health [mHealth]) behavioral treatmen...

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Main Authors: Ana Maria Ruiz-Leon, Rosa Casas, Sara Castro-Barquero, Sofia Alfaro-González, Petia Radeva, Emilio Sacanella, Francesc Casanovas-Garriga, Ainhoa Pérez-Gesalí, Ramon Estruch
Format: Article
Language:English
Published: JMIR Publications 2025-01-01
Series:Journal of Medical Internet Research
Online Access:https://www.jmir.org/2025/1/e58319
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author Ana Maria Ruiz-Leon
Rosa Casas
Sara Castro-Barquero
Sofia Alfaro-González
Petia Radeva
Emilio Sacanella
Francesc Casanovas-Garriga
Ainhoa Pérez-Gesalí
Ramon Estruch
author_facet Ana Maria Ruiz-Leon
Rosa Casas
Sara Castro-Barquero
Sofia Alfaro-González
Petia Radeva
Emilio Sacanella
Francesc Casanovas-Garriga
Ainhoa Pérez-Gesalí
Ramon Estruch
author_sort Ana Maria Ruiz-Leon
collection DOAJ
description BackgroundEnhancing self-management in health care through digital tools is a promising strategy to empower patients with type 2 diabetes (T2D) to improve self-care. ObjectiveThis study evaluates whether the Greenhabit (mobile health [mHealth]) behavioral treatment enhances T2D outcomes compared with standard care. MethodsA 12-week, parallel, single-blind randomized controlled trial was conducted with 123 participants (62/123, 50%, female; mean age 58.25 years, SD 9.46 years) recently diagnosed with T2D. Participants were recruited face-to-face from primary care centers in Barcelona, Spain, between July 2021 and March 2022. They were randomly assigned to 1 of 2 groups: (1) an intervention group (n=61) instructed to use the Greenhabit mobile app alongside standard care, or (2) a control group (n=62) who received advice on maintaining a healthy diet and followed standard care. The Greenhabit app incorporates serious gaming technology. Participants received daily messages and challenges focused on promoting a healthy lifestyle, including nutrition, exercise, relaxation, a positive mindset, and a supportive social environment. The app encouraged participants to set weekly goals and awarded points for completing challenges. Data on nutrition, anthropometrics, and blood and urine samples were collected at baseline, 6 weeks, and 12 weeks. Questionnaires assessing quality of life, work-life balance, and social environment were administered at baseline and during the final visit. The primary outcomes were HbA1c and fasting plasma glucose (FPG). Repeated-measures analysis of variance was used to compare changes over time (baseline to 6 weeks and baseline to 12 weeks) between the 2 intervention groups. Analysis of covariance was performed to evaluate changes at 6 and 12 weeks, adjusted for baseline levels of each variable. Multiple contrasts were corrected using a Bonferroni post hoc test. ResultsBoth groups showed significant reductions in HbA1c after 6 and 12 weeks (mean change in the intervention group [n=50] –0.4%, P<.001 vs –0.3% in the control group [n=53], P=.001) and in FPG after 6 weeks (mean change in the intervention group –5.3 mg/dL, P=.01 vs control group –5.8 mg/dL, P=.01). At 12 weeks, the intervention group also showed significant reductions in systolic and diastolic blood pressures (mean change –4.5, P=.049 and –2.4 mmHg, P=.03, respectively), body weight (mean change –0.8 kg, P=.03), BMI (mean change –0.3 kg/m2, P=.03), waist circumference (mean change –1.0 cm, P=.046), and triglyceride concentration (mean change –20.0 mg/dL, P=.03). There was also a significant increase in high-density lipoprotein-cholesterol concentrations (mean change 2 mg/dL, P=.049). Finally, improvements were noted in 3 out of the 5 elements of balance: positivity, social environment, and work-life balance. ConclusionsThe 12-week intervention with the Greenhabit behavioral treatment mHealth app showed beneficial effects on T2D outcomes and reduced the burden of cardiovascular risk factors. Although larger studies are warranted, these results suggest that mHealth apps can be a promising tool for improving T2D self-management. Trial RegistrationISRCTN Registry ISRCTN13456652; http://www.isrctn.com/ISRCTN13456652
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spelling doaj-art-3435801298a5409ba59df9b93b5dacc92025-01-22T17:00:36ZengJMIR PublicationsJournal of Medical Internet Research1438-88712025-01-0127e5831910.2196/58319Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled TrialAna Maria Ruiz-Leonhttps://orcid.org/0000-0001-8180-5991Rosa Casashttps://orcid.org/0000-0002-0211-9166Sara Castro-Barquerohttps://orcid.org/0000-0002-6876-5443Sofia Alfaro-Gonzálezhttps://orcid.org/0000-0001-9726-8377Petia Radevahttps://orcid.org/0000-0003-0047-5172Emilio Sacanellahttps://orcid.org/0000-0001-8018-1523Francesc Casanovas-Garrigahttps://orcid.org/0000-0002-0258-376XAinhoa Pérez-Gesalíhttps://orcid.org/0009-0006-8044-2491Ramon Estruchhttps://orcid.org/0000-0003-1260-4445 BackgroundEnhancing self-management in health care through digital tools is a promising strategy to empower patients with type 2 diabetes (T2D) to improve self-care. ObjectiveThis study evaluates whether the Greenhabit (mobile health [mHealth]) behavioral treatment enhances T2D outcomes compared with standard care. MethodsA 12-week, parallel, single-blind randomized controlled trial was conducted with 123 participants (62/123, 50%, female; mean age 58.25 years, SD 9.46 years) recently diagnosed with T2D. Participants were recruited face-to-face from primary care centers in Barcelona, Spain, between July 2021 and March 2022. They were randomly assigned to 1 of 2 groups: (1) an intervention group (n=61) instructed to use the Greenhabit mobile app alongside standard care, or (2) a control group (n=62) who received advice on maintaining a healthy diet and followed standard care. The Greenhabit app incorporates serious gaming technology. Participants received daily messages and challenges focused on promoting a healthy lifestyle, including nutrition, exercise, relaxation, a positive mindset, and a supportive social environment. The app encouraged participants to set weekly goals and awarded points for completing challenges. Data on nutrition, anthropometrics, and blood and urine samples were collected at baseline, 6 weeks, and 12 weeks. Questionnaires assessing quality of life, work-life balance, and social environment were administered at baseline and during the final visit. The primary outcomes were HbA1c and fasting plasma glucose (FPG). Repeated-measures analysis of variance was used to compare changes over time (baseline to 6 weeks and baseline to 12 weeks) between the 2 intervention groups. Analysis of covariance was performed to evaluate changes at 6 and 12 weeks, adjusted for baseline levels of each variable. Multiple contrasts were corrected using a Bonferroni post hoc test. ResultsBoth groups showed significant reductions in HbA1c after 6 and 12 weeks (mean change in the intervention group [n=50] –0.4%, P<.001 vs –0.3% in the control group [n=53], P=.001) and in FPG after 6 weeks (mean change in the intervention group –5.3 mg/dL, P=.01 vs control group –5.8 mg/dL, P=.01). At 12 weeks, the intervention group also showed significant reductions in systolic and diastolic blood pressures (mean change –4.5, P=.049 and –2.4 mmHg, P=.03, respectively), body weight (mean change –0.8 kg, P=.03), BMI (mean change –0.3 kg/m2, P=.03), waist circumference (mean change –1.0 cm, P=.046), and triglyceride concentration (mean change –20.0 mg/dL, P=.03). There was also a significant increase in high-density lipoprotein-cholesterol concentrations (mean change 2 mg/dL, P=.049). Finally, improvements were noted in 3 out of the 5 elements of balance: positivity, social environment, and work-life balance. ConclusionsThe 12-week intervention with the Greenhabit behavioral treatment mHealth app showed beneficial effects on T2D outcomes and reduced the burden of cardiovascular risk factors. Although larger studies are warranted, these results suggest that mHealth apps can be a promising tool for improving T2D self-management. Trial RegistrationISRCTN Registry ISRCTN13456652; http://www.isrctn.com/ISRCTN13456652https://www.jmir.org/2025/1/e58319
spellingShingle Ana Maria Ruiz-Leon
Rosa Casas
Sara Castro-Barquero
Sofia Alfaro-González
Petia Radeva
Emilio Sacanella
Francesc Casanovas-Garriga
Ainhoa Pérez-Gesalí
Ramon Estruch
Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial
Journal of Medical Internet Research
title Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial
title_full Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial
title_fullStr Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial
title_full_unstemmed Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial
title_short Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial
title_sort efficacy of a mobile health based behavioral treatment for lifestyle modification in type 2 diabetes self management greenhabit randomized controlled trial
url https://www.jmir.org/2025/1/e58319
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