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A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial.

ABSTRACT: BACKGROUND:In order to achieve improved weight status, behavioral pediatric obesity treatment is resource intensive. Mobile Health (mHealth) is more accessible than standard care but effective approaches are scarce. Therefore, the aim of this feasibility trial was to study trial design, mHealth usage, compliance, and acceptability of a novel mHealth approach in pediatric obesity treatment. METHODS:This six-month parallel two-arm feasibility trial took place at three pediatric outpatient clinics in Stockholm, Sweden. Participants, 5-12?years, starting obesity treatment were randomized to using an mHealth support system as an addition to standard care (intervention) or to standard care alone (control). The intervention included daily self-monitoring of weight transferred to a mobile application (app) used by parents, a website in which clinicians could track treatment progress, prespecified treatment goals for change in degree of obesity shown in the app and on the website, and text message interactions between clinicians and parents. The main outcome was description of feasibility. Height and weight were measured at baseline, three, and 6 months to explore changes in body mass index standard deviation score (BMI SDS). RESULTS:Of 40 children eligible for inclusion, 28 agreed to participate (54% girls) and were randomized to intervention (n =?15) or control (n =?13). Weight was measured at home regularly throughout the entire trial period by 12/15 children in the intervention group. Attendance at appointments were better in the intervention group (p?=?0.024). Both parents and clinicians had a positive experience and found the mHealth support system accessible. At 6 months the intervention group had a greater reduction of 0.24?units in BMI SDS than standard care (-?0.23 vs. 0.01, p?=?0.002). CONCLUSIONS:The mHealth support system was a feasible and innovative treatment approach which, in addition to standard care, generated better treatment results than standard care alone. Future research should evaluate the treatment effects over a longer follow-up time in a larger study sample. TRIAL REGISTRATION:This trial was retrospectively registered at ClinicalTrials.gov , ID: NCT03380598 , on November 8, 2017.

SUBMITTER: Johansson L

PROVIDER: S-EPMC7513491 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial.

Johansson Linnea L Hagman Emilia E Danielsson Pernilla P

BMC pediatrics 20200923 1

<h4>Background</h4>In order to achieve improved weight status, behavioral pediatric obesity treatment is resource intensive. Mobile Health (mHealth) is more accessible than standard care but effective approaches are scarce. Therefore, the aim of this feasibility trial was to study trial design, mHealth usage, compliance, and acceptability of a novel mHealth approach in pediatric obesity treatment.<h4>Methods</h4>This six-month parallel two-arm feasibility trial took place at three pediatric outp ...[more]

PMID: 32967638

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Project description:BackgroundPediatric obesity lifestyle treatment is not always successful. Frequent clinical visits are of major importance to certify sufficient effect but are difficult due to the associated costs and the great demands on families. We hypothesized that an interactive digital support may reduce the need for frequent physical visits. The aim of the study was to assess 1-year weight outcome for patients using a digital support system compared with standard care.MethodsAn obesity lifestyle treatment with a digital support system was implemented in one clinic in Stockholm, Sweden. Measurements from a custom-made body scale without digits for daily home measurement of weights were transferred via Bluetooth to a mobile application, where BMI Z-score was calculated and presented graphically with an individualized weight loss target curve. An automatic transfer of data to the web-based clinic interface enables a close monitoring of treatment progress, and frequent written communication between the clinical staff and families via the application. One-year outcome was compared with a randomly retrieved, age and sex matched control group from the Swedish childhood obesity treatment register (BORIS), which received standard treatment at other clinics. Main outcome was change in BMI Z-score and missing data was imputed.Results107 children were consecutively included to digi-physical treatment and 321 children to standard care. Age range 4.1-17.4 years (67% males). The attrition rate was 36% and 46% respectively, p = 0.08. After 1 year, the mean ± SD change in BMI Z-score in the treatment group was -0.30 ± 0.39 BMI Z-score units and in the standard care group -0.15 ± 0.28, p = 0.0002. The outcome was better for both sexes and all age groups in the digi-physical treated group.ConclusionA digital support system with a personalized weight-loss target curve and daily weight measurements shared by the family and the clinic is more effective than a standard care childhood obesity treatment.ClinicaltrialGov idNCT04323215.

Project description:BackgroundDiabetes is a highly prevalent long-term condition with high morbidity and mortality rates. People with diabetes commonly worry about their diabetes medicines and do not always take them regularly as prescribed. This can lead to poor diabetes control. The Support Through Mobile Messaging and Digital Health Technology for Diabetes (SuMMiT-D) study aims to deliver brief messages as tailored interventions to support people with type 2 diabetes in better use of their diabetes medicines and to improve treatment adherence and health outcomes.ObjectiveThis paper describes the overall architecture of a tailored intervention delivery system used in the pilot and randomized controlled feasibility studies of SuMMiT-D and reports its performance.MethodsThe SuMMiT-D system includes several platforms and resources to recruit participants and deliver messages as tailored interventions. Its core component is called the clinical system and is responsible for interacting with the participants by receiving and sending SMS text messages from and to them. The personalization and tailoring of brief messages for each participant is based on a list of built-in commands that they can use.ResultsFor the pilot study, a total of 48 participants were recruited; they had a median age of 64 years (first quartile, third quartile [Q1, Q3: 54.5, 69]). For the feasibility study, a total of 209 participants were recruited and randomly assigned to either the control or intervention group; they had a median age of 65 years (Q1, Q3: 56, 71), with 41.1% (86/209) being female. The participants used the SuMMiT-D system for up to 6 months (26 weeks) and had a wide range of different interactions with the SuMMiT-D system while tailored interventions were being delivered. For both studies, we had low withdrawal rates: only 4.2% and 5.3% for the pilot and feasibility studies, respectively.ConclusionsA system was developed to successfully deliver brief messages as tailored health interventions to more than 250 people with type 2 diabetes via SMS text messages. On the basis of the low withdrawal rates and positive feedback received, it can be inferred that the SuMMiT-D system is robust, user-friendly, useful, and positive for most participants. From the two studies, we found that online recruitment was more efficient than recruitment via postal mail; a regular SMS text reminder (eg, every 4 weeks) can potentially increase the participants' interactions with the system.Trial registrationISRCTN Registry ISRCTN13404264; http://www.isrctn.com/ISRCTN13404264.

Project description:BACKGROUND:Shared decision making (SDM) is recognized as a person-centered approach to improving health care quality and outcomes. Few digital interventions to improve SDM have been tested in child and adolescent mental health (CAMH) settings. One such intervention is Power Up, a mobile phone app for young people (YP), which has shown some evidence of promise that YP who received Power Up reported greater levels of SDM. However, even though parents play a critical role in CAMH care and treatment, they often feel excluded from services. OBJECTIVE:This protocol is for a pilot trial to determine the feasibility of a large-scale randomized trial to develop and evaluate a Web app called Power Up for Parents (PUfP) to support parents and promote involvement in CAMH decisions. METHODS:A 2-stage process, consisting of the development stage and pilot-testing stage of the initial PUfP prototype, will be conducted. At the development stage, a qualitative study with parents and clinicians will be conducted. The interviews will aim to capture the experience of making CAMH decisions, preferences for involvement in SDM, and determine situations within which PUfP can be useful. At the pilot-testing stage, up to 90 parents and their clinicians will be invited to participate in the testing of the prototype. Parents will be randomly allocated to receive the intervention or be part of the control group. This study design will allow us to assess the acceptability and usefulness of PUfP in addition to examining the feasibility of a prospective randomized trial. Clinicians' perceptions of the prototype and how it has influenced parents' involvement in SDM will also be examined. RESULTS:Recruitment began in January 2019 and is scheduled to last for 10 months. Interviews and baseline data collection are currently in progress. To date, 11 CAMH sites have been recruited to take part in the study. It is anticipated that data collection will be completed by October 2019. CONCLUSIONS:The lack of parents' involvement in CAMH care and treatment can lead to higher rates of dropout from care and lower adherence to therapeutic interventions. There are significant benefits to be gained globally if digital SDM interventions are adopted by parents and shown to be successful in CAMH settings. TRIAL REGISTRATION:ISRCTN Registry ISRCTN39238984; http://www.isrctn.com/ISRCTN39238984. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14571.

Project description:BackgroundIndividuals with spinal cord injury (SCI) are at risk for secondary medical complications, such as urinary tract infections (UTIs) and pressure injuries, that could potentially be mitigated through improved self-management techniques. The Interactive Mobile Health and Rehabilitation (iMHere) mobile health (mHealth) system was developed to support self-management for individuals with disabilities.ObjectiveThe main objective of this study was to determine if the use of iMHere would be associated with improved health outcomes over a 9-month period. A secondary objective was to determine if the use of iMHere would be associated with improved psychosocial outcomes. Phone usage, app usage, and training time data were also collected to analyze trends in iMHere use.MethodsOverall, 38 participants with SCI were randomized into either the intervention group who used the iMHere system and received standard care or the control group who received standard care without any technology intervention. Health outcomes were recorded for the year before entry into the study and during the 9 months of the study. Participants completed surveys at baseline and every 3 months to measure psychosocial outcomes.ResultsThe intervention group had a statistically significant reduction in UTIs (0.47 events per person; P=.03; number needed to treat=2.11). Although no psychosocial outcomes changed significantly, there was a nonsignificant trend toward a reduction in mood symptoms in the intervention group compared with the control group meeting the threshold for clinical significance. Approximately 34 min per participant per month were needed on average to manage the system and provide technical support through this mHealth system.ConclusionsThe use of the iMHere mHealth system may be a valuable tool in the prevention of UTIs or reductions in depressive symptoms. Given these findings, iMHere has potential scalability for larger populations.Trial registrationClinicalTrials.gov NCT02592291; https://clinicaltrials.gov/ct2/show/NCT02592291.

Project description:BACKGROUND:Effective preventive treatments for dental decay exist, but caries experience among preschoolers has not changed, with marked disparities in untreated decay. Despite near-universal use of SMS text messaging, there are no studies using text messages to improve the oral health of vulnerable children. OBJECTIVE:This randomized controlled feasibility trial aimed to test the effects of oral health text messages (OHT) versus a control (child wellness text messages or CWT). OHT was hypothesized to outperform CWT on improving pediatric oral health behaviors and parent attitudes. METHODS:Parents with a child aged <7 years were recruited at urban clinics during pediatric appointments (79% [41/52] below poverty line; 66% [36/55] black) and randomized to OHT (text messages on brushing, dental visits, bottle and sippy cups, healthy eating and sugary beverages, and fluoride) or CWT (text messages on reading, safety, physical activity and development, secondhand smoke, and stress) groups. Automated text messages based on Social Cognitive Theory were sent twice each day for 8-weeks. Groups were equivalent on the basis of the number of text messages sent, personalization, interactivity, and opportunity to earn electronic badges and unlock animated characters. Assessments were conducted at baseline and 8 weeks later. Data were analyzed with linear mixed-effects models. RESULTS:A total of 55 participants were randomized (28 OHT and 27 CWT). Only one participant dropped out during the text message program and 47 (24 OHT and 23 CWT) completed follow up surveys. Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range). Of the OHT group participants, 84% (21/25) would recommend the program to others. Overall program likeability scores were high (OHT mean 5.90; CWT mean 6.0; 1-7 scale range). Participants reported high perceived impact of the OHT program on brushing their child's teeth, motivation to address their child's oral health, and knowledge of their child's oral health needs (mean 4.7, 4.6, and 4.6, respectively; 1-5 scale range). At follow up, compared with CWT, OHT group participants were more likely to brush their children's teeth twice per day (odds ratio [OR] 1.37, 95% CI 0.28-6.50) and demonstrated improved attitudes regarding the use of fluoride (OR 3.82, 95% CI 0.9-16.8) and toward getting regular dental checkups for their child (OR 4.68, 95% CI 0.24-91.4). There were modest, but not significant, changes in motivation (F1,53=0.60; P=.45) and self-efficacy (F1,53=0.24; P=.63) to engage in oral health behaviors, favoring OHT (d=0.28 and d=0.16 for motivation and self-efficacy, respectively). CONCLUSIONS:The OHT program demonstrated feasibility was well utilized and appealing to the target population and showed promise for efficacy.

Dataset Information

A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial.

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A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial.

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