Accepted for/Published in: JMIR Formative Research
Date Submitted: Jul 18, 2023
Date Accepted: Oct 19, 2023
Pilot Randomized Controlled Trial: Mobile Intervention Designed Specifically for Older Adults with Frailty to Support Healthy Eating
ABSTRACT
Background:
Frailty, a common geriatric syndrome, predisposes older adults to functional decline. No medications can alter frailty's trajectory, but nutritional interventions may aid function preservation.
Objective:
This paper presents a pilot randomized controlled trial (RCT) to investigate the feasibility and efficacy of a mobile health intervention, "Olitor," designed to enhance adherence to the Mediterranean diet among older adults with frailty.
Methods:
The study sample consisted of 15 participants aged 66-77 years (mean age=70.5, SD=3.96) randomized into intervention (n=8; 8 females; mean age=72.4, SD=4.8) and control groups (n=7; 6 females, 1 male; mean age=70.0, SD=3.9). The intervention involved a patient-facing mobile app called "Olitor" and a secure web-based administrative dashboard. Participants were instructed to use the app at least weekly for three months, which provided feedback on their food choices, personalized recipe recommendations, and an in-app messaging feature. Using Mann-Whitney U tests to compare change scores and Hedges' g statistics to estimate effect sizes, the primary outcomes assessed were adherence to the Mediterranean diet score and insulin resistance measures.
Results:
The findings demonstrated a significant improvement in the Mediterranean Diet adherence score in the intervention group compared to the control (W=50.5, P<0.01), with median change scores of 2 (IQR 2, 4.25) and 0 (-0.50, 0.50), respectively. A small and insignificant reduction in insulin resistance was observed in the intervention group, with the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) showing a median change of -0.2 (SD=0.72) compared to the control group with a median change of 0.1 (SD=0.74) (W=23, P=0.6). Additionally, there were significant increases in vegetable (W=47, P=0.03) and legume intake (W=54, P=0.001), and a statistically and clinically significant improvement in the Short Physical Performance Battery (SPPB) measure (W=45, P=0.049) in the intervention group. The intervention's effect size was large for several outcomes, such as Mediterranean Diet Adherence (Hedges’ g =1.58, CI=0.34-2.67) and vegetable intake (Hedges’ g =1.14, CI=0.08, 2.21). The app's overall quality rating was favorable, with an average interaction time of twelve minutes weekly.
Conclusions:
This pilot study revealed the potential of the mobile intervention "Olitor" in promoting healthier eating habits among older adults with frailty. It demonstrated high retention rates, significant improvement in adherence to the Mediterranean diet, and increased intake of recommended foods. While insulin resistance showed a minor non-significant improvement, lower extremity function, and Mediterranean diet knowledge significantly increased. Although the app's behavior change features were similar to those of previous eHealth interventions, the distinctive focus on theory-informed mechanistic measures involved in behavioral change, such as self-regulation, self-efficacy, and expected negative outcomes, may have enhanced its efficacy. Further investigations in a more diverse and representative population are warranted to validate these preliminary findings. Clinical Trial: NCT05236712
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