Implementation of clinical research trials using web-based and mobile devices: challenges and solutions.

BACKGROUND: With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature. RESULTS: The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy. CONCLUSION: We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.

The Health Initiative Program for Kids (HIP Kids): effects of a 1-year multidisciplinary lifestyle intervention on adiposity and quality of life in obese children and adolescents--a longitudinal pilot intervention study.

BACKGROUND: Though recent data suggest that multidisciplinary outpatient interventions can have a positive effect on childhood obesity, it is still unclear which program components are most beneficial and how they affect quality of life (QoL). The aim of this study was to determine if a 1-year multidisciplinary, family-centered outpatient intervention based on social cognitive theory would be effective in (i) preventing further increases in BMI and BMI z-score, and (ii) improving QoL in obese children and adolescents. METHODS: Obese children and adolescents 8-17 years of age and their families participated in this 1-year longitudinal pilot intervention study. The intervention consisted of fifteen 90-minute educational sessions led by a dietitian, exercise specialist, and social worker. Anthropometric measures, body composition, and QoL (Pediatric Quality of Life Inventory 4.0), were assessed at baseline, 3 months, and 12 months. Laboratory values were measured at baseline and 12 months. The primary outcome measures were change in BMI and BMI z-score, secondary outcome measures included change in QoL and body composition. A paired sample t-test was used to assess within-group differences and 95% confidence intervals were reported for the mean differences. RESULTS: 42 obese children and adolescents (21 girls) completed the 1-year intervention (mean age 12.8 ± 3.14 years). Mean baseline BMI was 31.96 ± 5.94 kg/m(2) and BMI z-score was +2.19 ± 0.34. Baseline QoL (self-assessments and parental assessments) was impaired: mean baseline scores were 74.5 ± 16.5 and 63.7 ± 19.4 for physical functioning and 69.0 ± 14.9 and 64.0 ± 18.3 for emotional functioning, respectively. At 12 months, BMI z-score had decreased (-0.07 ± 0.11, 95% CI: -0.11 to -0.04). BMI (0.80 ± 1.57 kg/m(2), 95% CI 0.31 to 1.29) and fat-free mass (4.02 ± 6.27 kg, 95% CI 1.90 to 6.14) increased, but % body fat and waist circumference did not. Both the parent-reported physical (11.3 ± 19.2, 95% CI 4.7 to 17.9) and emotional (7.7 ± 15.7, 95% CI 2.3 to 13.0) functioning QoL scores and the children's self-reported physical (5.3 ± 17.1, 95% CI 0.5 to 11.1) and emotional (7.9 ± 14.3, 95% CI 3.2 to 12.7) functioning scores significantly improved. CONCLUSIONS: Following a 1-year intervention, the participants' BMI z-scores and QoL improved, while other adiposity-related measures of body composition remained unchanged. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000015622 .

Improving remote lifestyle intervention studies in children: Participant and caregiver feedback of the smart heart study.

OBJECTIVES: We sought to describe and analyze the quantitative and qualitative feedback obtained from participants and their caregivers of the Smart Heart study, a successful 12-month lifestyle intervention for children with overweight or obesity and congenital heart disease that provided remote lifestyle counseling, to improve future lifestyle interventions in children. METHODS: Thirty-six participants and caregivers were polled using a standard program evaluation questionnaire at the end of the intervention. Feedback was compiled into themes, and facilitators and barriers to program success were identified. RESULTS: There was a high level of satisfaction with the intervention and staff interactions as well as a low perceived burden of participation. There were also specific concerns, including mixed impressions regarding technology usage and a less impressive indication of actual impactful behavior change. CONCLUSIONS: The study identified five themes, and corresponding facilitators and barriers to participant compliance, from the Smart Heart intervention feedback and offered suggestions for improving future lifestyle behavioral intervention study designs in children. PRACTICE IMPLICATIONS: Remote smartphone counseling is effective and efficient. It is recommended that the counseling messages are specific, the counseling schedule is patient-centric, patient burden is limited, methods with immediate patient feedback are used and family is included when feasible.

The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial.

BACKGROUND: Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counseling for weight management offers great potential to appeal to technologically literate youth and can address a large geographical area with minimal burden to participants. This pilot study seeks to examine the influence of a 1-year lifestyle intervention on nutrition and physical activity-related health outcomes in overweight or obese children and adolescents with CHD. METHODS: This is a pilot and feasibility study which utilizes a single-arm, prospective design with a goal to recruit 40 overweight and obese patients. The feasibility metrics will evaluate the integrity of the study protocol, data collection and questionnaires, recruitment and consent, and acceptability of the intervention protocol and primary outcome measures. The primary clinical outcome metrics are anthropometry, body composition, and cardiorespiratory exercise capacity. The secondary clinical metrics include quality of life, nutrition and physical activity behavior, lung and muscle function, and cardio-metabolic risk factors. Outcomes are assessed at baseline, 6 months, and 1 year. To date, a total of 36 children and youth (11 girls), aged 7-17 years (mean = 14.4 years), have commenced the intervention. Recruitment for the study was initiated in June 2012 and is currently ongoing. DISCUSSION: The information provided in this paper is intended to help researchers and health professionals with the development and evaluation of similar lifestyle intervention programs. Since the application of smartphones to pediatric cardiac health and obesity management is a novel approach, and continued research in this area is warranted, this paper may serve as a foundation for further exploration of this health frontier and inform the development of a broader strategy for obesity management in pediatric cardiology. TRIAL REGISTRATION: This pilot study was retrospectively registered at the www.ClinicalTrials.gov registry as NCT02980393 in November 2016, with the study commencing in May 2012. Study protocol version 15OCT2014.

Remote Lifestyle Counseling Influences Cardiovascular Health Outcomes in Youth with Overweight or Obesity and Congenital Heart Disease.

BACKGROUND: Children with overweight/obesity and congenital heart disease (CHD) are at increased cardiovascular risk. A lifestyle intervention may help reduce these risks. We sought to determine the feasibility of a smartphone-based lifestyle intervention to improve cardiovascular health outcomes in children with overweight/obesity and CHD. METHODS: We examined the effect of bi-weekly nutrition and fitness counseling delivered via smartphone over 12 months. Thirty-four youth, previously diagnosed with CHD and with overweight or obesity, participated in the intervention. They were divided into two groups depending on whether the heart disease required surgical correction (operated, n = 19) or not (non-operated, n = 15). Anthropometry, body composition cardiorespiratory exercise capacity, and cardio-metabolic risk factors were assessed at baseline, 6 months, and 12 months. RESULTS: Statistically significant decreases in waist circumference (WC), body mass index z-score, WC z-score, and waist to height ratio z-score were observed at 6 and 12 months in the operated group. A significant linear increase in lean body mass was observed in both groups. The study also had a high retention rate and a low attrition rate. CONCLUSION: The observed changes in anthropometry were positive with significant improvement to some cardiovascular and metabolic risk indicators. However, this was only observed in the operated group suggesting that other factors, such as perception of condition and self-efficacy, may influence lifestyle behaviors. The results from this pilot study clearly demonstrate the feasibility to perform a larger controlled study on remote lifestyle intervention in children with congenital heart defects and overweight or obesity.