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Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Oct 4, 2020
Date Accepted: Feb 1, 2022

The final, peer-reviewed published version of this preprint can be found here:

Clinical Outcomes Among Working Adults Using the Health Integrator Smartphone App: Analyses of Prespecified Secondary Outcomes in a Randomized Controlled Trial

Bonn SE, Licitra G, Bellocco R, Trolle Lagerros Y

Clinical Outcomes Among Working Adults Using the Health Integrator Smartphone App: Analyses of Prespecified Secondary Outcomes in a Randomized Controlled Trial

J Med Internet Res 2022;24(3):e24725

DOI: 10.2196/24725

PMID: 35311677

PMCID: 8946520

Clinical outcomes among working adults using the Health Integrator smartphone application: analyses of pre-specified secondary outcomes in a randomized controlled trial

  • Stephanie Erika Bonn; 
  • Gabriella Licitra; 
  • Rino Bellocco; 
  • Ylva Trolle Lagerros

ABSTRACT

Background:

There is a need to find new models that can enhance the individuals´ engagement in self-care and increase compliance to a healthy lifestyle for the prevention of non-communicable diseases. mHealth applications could provide large-scale, cost-efficient digital solutions to implement lifestyle change.

Objective:

To evaluate if the use of a smartphone based self-management system, the Health Integrator application, with or without telephone counselling by a health coach, had an effect on clinical variables of importance for non-communicable diseases.

Methods:

The study was a three-armed parallel randomized controlled trial. Participants were randomized to a control group, or to one of two intervention groups using the Health Integrator application with or without additional telephone counselling during three months. Clinical variables were assessed before the start of the intervention (baseline) and after three months. Within and between group comparisons were performed. Robust regression with complete case analysis was used to analyze the intervention effect between the groups. Statistical analyses were also stratified by type of work (office worker vs. bus driver).

Results:

Complete data at baseline and follow-up was obtained from 205 and 168 participants, respectively. The mean age of participants was 48(±10) years, 59% were men, and 52% were bus drivers. Within-group comparisons showed significant improvements in BMI (P < .05) and waist circumference (P < .01) after three months in both groups receiving the Health Integrator application. Among those receiving additional coach support, systolic blood pressure was also improved (P = .03). Clinical improvements were observed at follow-up among participants in the intervention arms, i.e. there was a positive effect on waist circumference (β=-0.99, 95%CI -1.86 to -0.11) in the group receiving the application and additional coach support, compared to the control group. Participants receiving only the application had a lower BMI (β=-0.35, 95%CI: -0.62 to -0.07), body weight (β=-1.06, 95%CI: -1.91 to -0.21) and waist circumference (β=-1.36, 95%CI: -2.23 to -0.49) at follow-up, compared to the controls. Whilst improvements in variables related to body weight seemed to be driven by bus drivers, the lowering of blood pressure was more pronounced among office workers.

Conclusions:

The Health Integrator application show promising results with regard to positive changes in body weight, BMI and waist circumference seen in a 3-month intervention. Clinical Trial: ClinicalTrials.gov Identifier: NCT03579342. Retrospectively registered, first submitted May 8, 2018.


 Citation

Please cite as:

Bonn SE, Licitra G, Bellocco R, Trolle Lagerros Y

Clinical Outcomes Among Working Adults Using the Health Integrator Smartphone App: Analyses of Prespecified Secondary Outcomes in a Randomized Controlled Trial

J Med Internet Res 2022;24(3):e24725

DOI: 10.2196/24725

PMID: 35311677

PMCID: 8946520

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