Effect of a smartphone application (Perx) on medication adherence and clinical outcomes: a 12-month randomised controlled trial.

OBJECTIVE: To determine whether the Perx app improves medication adherence and clinical outcomes over 12 months compared with standard care in patients requiring polypharmacy. DESIGN: Randomised controlled trial with 12-month follow-up. SETTING: Outpatient clinics in three tertiary hospitals in Sydney, Australia. PARTICIPANTS: Eligible participants were aged 18-75 years, with at least one chronic condition, taking ≥3 different medications (oral medications or injections), with smartphone accessibility. Participants were randomised in a 1:1 ratio. INTERVENTIONS: The intervention group used the Perx app that contained customised reminders and gamified interactions to reward verified medication adherence. MAIN OUTCOME MEASURES: The primary outcome was medication adherence over 12 months measured using pill counts. Secondary outcomes included clinical outcomes (haemoglobin A1c (HbA1c), cholesterol, blood glucose, triglycerides, creatinine, thyroid function, blood pressure and weight). RESULTS: Of 1412 participants screened for eligibility, 124 participants were randomised; 45 in the Perx arm and 40 in the control arm completed the study. The average age was 59.5, 58.9% were women, chronic conditions were cardiovascular disease (78%), type 2 diabetes (75%), obesity (65%) or other endocrine disorders (18%). On average, participants were taking six medications daily. The Perx group had greater improvements in adherence at month 2 (Coef. 8%; 95% CI 0.01 to 0.15), month 3 (Coef. 7%; 95% CI 0.00 to 0.14) and month 12 (Coef. 7%; 95% CI 0.00 to 0.13). The probability of HbA1c ≤6.5% was greater in the Perx group at months 9 and 12 and cholesterol (total and low-density lipoprotein cholesterol) was lower in the Perx group at month 3. The intervention was particularly effective for those with obesity, taking medications for diabetes and taking ≤4 medications. CONCLUSIONS: This study provides evidence that app-based behavioural change interventions can increase medication adherence and produce longer-term improvements in some clinical outcomes in adults managing multimorbidity. More trials are needed to build the evidence base. TRIAL REGISTRATION NUMBER: ACTRN12617001285347.

Impact of the Growing Healthy mHealth Program on Maternal Feeding Practices, Infant Food Preferences, and Satiety Responsiveness: Quasi-Experimental Study.

BACKGROUND: Infancy is an important life stage for obesity prevention efforts. Parents' infant feeding practices influence the development of infants' food preferences and eating behaviors and subsequently diet and weight. Mobile health (mHealth) may provide a feasible medium through which to deliver programs to promote healthy infant feeding as it allows low cost and easy access to tailored content. OBJECTIVE: The objective of this study was to describe the effects of an mHealth intervention on parental feeding practices, infant food preferences, and infant satiety responsiveness. METHODS: A quasi-experimental study was conducted with an mHealth intervention group (Growing Healthy) and a nonrandomized comparison group ("Baby's First Food"). The intervention group received access to a free app with age-appropriate push notifications, a website, and an online forum that provided them with evidence-based advice on infant feeding for healthy growth from birth until 9 months of age. Behavior change techniques were selected using the Behaviour Change Wheel framework. Participants in both groups completed three Web-based surveys, first when their infants were less than 3 months old (baseline, T1), then at 6 months (time 2, T2), and 9 months of age (time 3, T3). Surveys included questions on infant feeding practices and beliefs (Infant Feeding Questionnaire, IFQ), satiety responsiveness (Baby Eating Behaviour Questionnaire), and infant's food exposure and liking. Multivariate linear regression models, estimated using maximum likelihood with bootstrapped standard errors, were fitted to compare continuous outcomes between the intervention groups, with adjustment for relevant covariates. Multivariate logistic regression adjusting for the same covariates was performed for categorical outcomes. RESULTS: A total of 645 parents (Growing Healthy: n=301, Baby's First Food: n=344) met the eligibility criteria and were included in the study, reducing to a sample size of 546 (Growing Healthy: n=234, Baby's First Food: n=312) at T2 and a sample size of 518 (Growing Healthy: n=225, Baby's First Food: n=293) at T3. There were approximately equal numbers of boy and girl infants, and infants were aged less than 3 months at baseline (Growing Healthy: mean 7.0, SD 3.7 weeks; Baby's First Food: mean 7.9, SD 3.8 weeks), with Growing Healthy infants being slightly younger than Baby's First Food infants (P=.001). All but one (IFQ subscale "concerns about infant overeating or becoming overweight" at T2) of the measured outcomes did not differ between Growing Healthy and Baby's First Food. CONCLUSIONS: Although mHealth can be effective in promoting some health behaviors and offers many advantages in health promotion, the results of this study suggest that design and delivery characteristics needed to maximize the impact of mHealth interventions on infant feeding are uncertain. The sensitivity of available measurement tools and differences in baseline characteristics of participants may have also affected the results.

Key Lessons and Impact of the Growing Healthy mHealth Program on Milk Feeding, Timing of Introduction of Solids, and Infant Growth: Quasi-Experimental Study.

BACKGROUND: The first year of life is an important window to initiate healthy infant feeding practices to promote healthy growth. Interventions delivered by mobile phone (mHealth) provide a novel approach for reaching parents; however, little is known about the effectiveness of mHealth for child obesity prevention. OBJECTIVE: The objective of this study was to determine the feasibility and effectiveness of an mHealth obesity prevention intervention in terms of reach, acceptability, and impact on key infant feeding outcomes. METHODS: A quasi-experimental study was conducted with an mHealth intervention group (Growing healthy) and a nonrandomized comparison group (Baby's First Food). The intervention group received access to a free app and website containing information on infant feeding, sleep and settling, and general support for parents with infants aged 0 to 9 months. App-generated notifications directed parents to age-and feeding-specific content within the app. Both groups completed Web-based surveys when infants were less than 3 months old (T1), at 6 months of age (T2), and 9 months of age (T3). Survival analysis was used to examine the duration of any breastfeeding and formula introduction, and cox proportional hazard regression was performed to examine the hazard ratio for ceasing breast feeding between the two groups. Multivariate logistic regression with adjustment for a range of child and parental factors was used to compare the exclusive breastfeeding, formula feeding behaviors, and timing of solid introduction between the 2 groups. Mixed effect polynomial regression models were performed to examine the group differences in growth trajectory from birth to T3. RESULTS: A total of 909 parents initiated the enrollment process, and a final sample of 645 parents (Growing healthy=301, Baby's First Food=344) met the eligibility criteria. Most mothers were Australian born and just under half had completed a university education. Retention of participants was high (80.3%, 518/645) in both groups. Most parents (226/260, 86.9%) downloaded and used the app; however, usage declined over time. There was a high level of satisfaction with the program, with 86.1% (143/166) reporting that they trusted the information in the app and 84.6% (170/201) claiming that they would recommend it to a friend. However, some technical problems were encountered with just over a quarter of parents reporting that the app failed to work at times. There were no significant differences between groups in any of the target behaviors. Growth trajectories also did not differ between the 2 groups. CONCLUSIONS: An mHealth intervention using a smartphone app to promote healthy infant feeding behaviors is a feasible and acceptable mode for delivering obesity prevention intervention to parents; however, app usage declined over time. Learnings from this study will be used to further enhance the program so as to improve its potential for changing infant feeding behaviors.

A Comparison of Recruitment Methods for an mHealth Intervention Targeting Mothers: Lessons from the Growing Healthy Program.

BACKGROUND: Mobile health (mHealth) programs hold great promise for increasing the reach of public health interventions. However, mHealth is a relatively new field of research, presenting unique challenges for researchers. A key challenge is understanding the relative effectiveness and cost of various methods of recruitment to mHealth programs. OBJECTIVE: The objectives of this study were to (1) compare the effectiveness of various methods of recruitment to an mHealth intervention targeting healthy infant feeding practices, and (2) explore factors influencing practitioner referral to the intervention. METHODS: The Growing healthy study used a quasi-experimental design with an mHealth intervention group and a concurrent nonrandomized comparison group. Eligibility criteria included: expectant parents (>30 weeks of gestation) or parents with an infant <3 months old, ability to read and understand English, own a mobile phone, ≥18 years old, and living in Australia. Recruitment to the mHealth program consisted of: (1) practitioner-led recruitment through Maternal and Child Health nurses, midwives, and nurses in general practice; (2) face-to-face recruitment by researchers; and (3) online recruitment. Participants' baseline surveys provided information regarding how participants heard about the study, and their sociodemographic details. Costs per participant recruited were calculated by taking into account direct advertising costs and researcher time/travel costs. Practitioner feedback relating to the recruitment process was obtained through a follow-up survey and qualitative interviews. RESULTS: A total of 300 participants were recruited to the mHealth intervention. The cost per participant recruited was lowest for online recruitment (AUD $14) and highest for practice nurse recruitment (AUD $586). Just over half of the intervention group (50.3%, 151/300) were recruited online over a 22-week period compared to practitioner recruitment (29.3%, 88/300 over 46 weeks) and face-to-face recruitment by researchers (7.3%, 22/300 over 18 weeks). No significant differences were observed in participant sociodemographic characteristics between recruitment methods, with the exception that practitioner/face-to-face recruitment resulted in a higher proportion of first-time parents (68% versus 48%, P=.002). Less than half of the practitioners surveyed reported referring to the program often or most of the time. Key barriers to practitioner referral included lack of time, difficulty remembering to refer, staff changes, lack of parental engagement, and practitioner difficulty in accessing the app. CONCLUSIONS: Online recruitment using parenting-related Facebook pages was the most cost effective and timely method of recruitment to an mHealth intervention targeting parents of young infants. Consideration needs to be given to addressing practitioner barriers to referral, to further explore if this can be a viable method of recruitment.