Describing the Process and Tools Adopted to Cocreate a Smartphone App for Obesity Prevention in Childhood: Mixed Method Study.

BACKGROUND: Childhood obesity prevention is a public health priority in industrialized countries. The Reggio Emilia Local Health Authority has implemented a program involving primary and secondary prevention as well as the care of obese children. There are many health-promoting mobile apps, but few are targeted to children and very few are sponsored by public health agencies. OBJECTIVE: The goal of the research was to describe the process and tools adopted to cocreate a mobile app sponsored by the Reggio Emilia Local Health Authority to be installed in parents' phones aimed at promoting child health and preventing obesity. METHODS: After stakeholder mapping, a consulting committee including relevant actors, stakeholders, and users was formed. Key persons for childhood obesity prevention were interviewed, focus groups with parents and pediatricians were conducted, and community reporting storytelling was collected. The results of these activities were presented to the consulting committee in order to define the functionalities and contents of the mobile app. RESULTS: Three key trends emerged from community reporting: being active, playing, and being outdoors; time for oneself, family, and friends; and the pressures of life and work and not having time to be active and socialize. In focus groups, interviews, and labs, mothers showed a positive attitude toward using an app to manage their children's weight, while pediatricians expressed concerns that the app could increase their workload. When these findings were explored by the consulting committee, four key themes were extracted: strong relationships with peers, family members, and the community; access to safe outdoor spaces; children's need for age-appropriate independence; and professional support should be nonjudgmental and stigma-free. It should be a dialogue that promotes family autonomy. The app functions related to these needs include the following: (1) newsletter with anticipatory guidance, recipes, and vaccination and well-child visit reminders; (2) regional map indicating where physical activity can be done; (3) information on how to manage emergencies (eg, falls, burns, fever); (4) module for reinforcing the counseling intervention conducted by pediatricians for overweight children; and (5) a function to build a balanced daily diet. CONCLUSIONS: The pilot study we conducted showed that cocreation in health promotion is feasible, with the consulting committee being the key co-governance and cocreation tool. The involvement of stakeholders in this committee made it possible to expand the number of persons and institutions actively contributing to the project.

Understanding the association between mother's education level and effectiveness of a child obesity prevention intervention: a secondary analysis of an RCT.

OBJECTIVES: to explain differences in effectiveness of paediatrician-led motivational interviewing (MI) in decreasing body mass index (BMI) between children of mothers with low or high education level. DESIGN: secondary analysis of a randomised control trial. SETTING AND PARTICIPANTS: individually randomized controlled trial previously conducted from 2011 to 2013 in the province of Reggio Emilia (Emilia-Romagna Region, Northern Italy). Eligible participants included in the trial were 372 (187 in the MI group and 185 in the control group) overweight children (BMI percentile >= 85th and < 95th) aged between 4 and 7 years, residing in the province of Reggio Emilia and under the care of paediatrician for >= 12 months. The intervention included 5 MI sessions based on the transtheoretical model of addiction and behavioural change delivered at 1, 4, 7, and 12 months after the baseline visit, when families had to define specific goals in changing physical activity (PA) and diet behaviours. MAIN OUTCOME MEASURES: primary: BMI score variation (ΔBMI) from baseline to 12 months; secondary: percentage of changes in parent-reported PA and dietary behaviours. RESULTS: a significant effect of MI on ΔBMI in children whose mothers had high education level (ΔBMI = -0.62; 95%CI -0.92;-0.32) were observed. Children of women with high education level in MI group had more improvements in set unstructured PA, decreasing screen time and sweet snacks consumption, while children with less educated mothers had improvements in consuming more vegetable soup and less desserts, sweet snacks, and sugary beverages. Highly educated mothers chose for their children to drink fewer sugary beverages and to increase PA. Less educated mothers most frequently chose as goals having breakfast, eating more fruit and vegetables, eating fewer snacks, and having less screen time. Overall achievement was similar in the two strata for diet goals, but higher for PA goals in the high education level stratum. CONCLUSIONS: MI intervention was not effective in reducing BMI in children of mothers with low education level. This does appear to be weakly or not associated with goal choices and achievement within MI, it is rather an effect of unmeasured behaviours which possibly mediate association between MI and BMI reduction.

High-frequency motor rehabilitation in amyotrophic lateral sclerosis: a randomized clinical trial.

OBJECTIVE: Exercise may be physically and psychologically important for people with ALS, especially in the earlier stages of the disease, and, as a consequence, current ALS clinical management includes individualized rehabilitation as part of multidisciplinary care because. However, while recent studies focused on which type of exercise is more indicated to ALS patients, there is no evidence at which frequency training sessions should be performed. METHODS: We performed an assessor blinded randomized clinical trial to investigate the superiority of two different frequencies of exercise on rate of progression in ALS. We enrolled 65 patients in two groups: intensive exercise regimen (IER, five sessions/week) versus usual exercise regimen (UER, two sessions/week). The primary aim was to assess if IER decreased disease progression, measured through Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised, with respect to UER. Secondary aims included assessment of adverse events, tracheostomy-free survival, motor and respiratory functions, fatigue, quality of life and caregiver burden. Treatment regimen consisted for both groups of the same kind of exercise including aerobic training, endurance training, stretching or assisted active mobilization, differing for frequency of intervention. RESULTS: No significant changes in disease progression were found in patients under IER versus UER. At the end of the study, there were no significant differences between the two groups in survival, respiratory function, time to supporting procedures, and quality of life. Adverse events, fatigue, and caregiver burden were not different between the two treatment regimens. CONCLUSIONS: Despite some limitations, our trial demonstrated that high-frequency physical exercise was not superior to UER on ALSFRS-R scores, motor and respiratory functions, survival, fatigue, and quality of life of ALS patients.

Impact of Referral Sources and Waiting Times on the Failure to Quit Smoking: One-Year Follow-Up of an Italian Cohort Admitted to a Smoking Cessation Service.

In Italy, the National Health Service offers specialized evidence-based support to smokers who would like to quit through smoking cessation (SC) services. We conducted a two-year prospective study, involving all 288 subjects treated for smoking cessation at the SC service of Reggio Emilia, to assess the association of referral sources and waiting times with the risk of treatment failure, by following participants up to one year after the quit date. We performed Cox-regression analysis, including demographic and smoking-related characteristics as confounding variables. The treatment failure rate at 12 months was 59.4% (171/288), including only 12 subjects lost to follow-up. The main mode of entry was self-referral (42.4%), followed by 32.6% from general practice, 17.4% from hospital and 7.6% from other sources. Only 27.8% participants were involved in the SC-program within 60 days of the first contact, as the guidelines suggest. The risk of treatment failure at 12 months showed little association with the type of referral source, while it correlated with waiting times ≥ 60 days (hazard ratio = 1.59; 95% confidence interval 1.10⁻2.29). This study provides evidence of long-term high quit rates from a SC service, with few subjects lost to follow-up and biochemical verification of almost all abstinent subjects. Timeliness in care provision could further improve the outcome.

Effectiveness of integrated care model for type 2 diabetes: A population-based study in Reggio Emilia (Italy).

AIMS: To compare the effectiveness of integrated care with that of the diabetes clinic care model in terms of mortality and hospitalisation of type 2 diabetes patients with low risk of complications. METHODS: Out of 27234 people with type 2 diabetes residing in the province of Reggio Emilia on 31/12/2011, 3071 were included in this cohort study as eligible for integrated care (i.e., low risk of complications) and cared for with the same care model for at least two years. These patients were followed up from 2012 to 2016, for all-cause and diabetes-related mortality and hospital admissions. We performed a Poisson regression model, using the proportion of eligible patients included in the integrated care model for each general practitioner as an instrumental variable. RESULTS: 1700 patients were cared for by integrated care and 1371 by diabetes clinics. Mortality rate ratios were 0.83 (95%CI 0.60-1.13) and 0.95 (95%CI 0.54-1.70) for all-cause and cardiovascular mortality, respectively, and incidence rate ratios were 0.90 (95%CI 0.76-1.06) and 0.91 (95%CI 0.69-1.20) for all-cause and cardiovascular disease hospitalisation, respectively. CONCLUSION: For low risk patients with type 2 diabetes, the integrated care model involving both general practitioner and diabetes clinic professionals showed similar mortality and hospitalisation as a model with higher use of specialized care in an exclusively diabetes clinic setting.

Motivational Interviewing to Treat Overweight Children: 24-Month Follow-Up of a Randomized Controlled Trial.

BACKGROUND: Pediatrician-led motivational interviewing can be an effective way of controlling BMI in overweight children in the short term. Its long-term efficacy is unknown. The primary aim was to determine whether the short-term (12-month) impact of family pediatrician-led motivational interviews on the BMI of overweight children could be sustained in the long term (24 months), in the absence of any other intervention. METHODS: Children were recruited in 2011 by family pediatricians working in the province of Reggio Emilia, Italy, and randomly allocated to receive either 5 interviews delivered over a 12-month period or usual care. Eligible participants were all 4- to 7-year-old overweight children resident in the province of Reggio Emilia who had been receiving care from the pediatrician for ≥ 12 months. The primary outcome of this study was individual variation in BMI between the baseline visit and the 24-month follow-up, assessed by pediatricians not blinded to treatment group allocation. RESULTS: Of 419 eligible families, 372 (89%) participated; 187 children were randomized to receive intervention and 185 to usual care. Ninety-five percent of the children attended the 12-month follow-up, and 91% attended the 24-month follow-up. After the 12-month intervention period, BMI in the intervention group increased less than in the control group (0.46 and 0.78, respectively; difference -0.32; P = .005). At the 24-month follow-up, the difference had disappeared (1.52 and 1.56, respectively; difference -0.04; P = .986). CONCLUSIONS: The intervention lost its effectiveness within 1 year of cessation. Sustainable boosters are required for weight control and obesity prevention.

Selenium speciation in human serum and its implications for epidemiologic research: a cross-sectional study.

Observational studies addressing the relation between selenium and human health, particularly cancer risk, yielded inconsistent results, while most recent randomized trials showed a fairly consistent pattern suggesting null or adverse effects of the metalloid. One of the most plausible explanations for such inconsistencies is inadequate exposure assessment in observational studies, commonly carried out by measuring total Se content without taking into account the specific exposure to the individual chemical forms of the metalloid, whose toxic and nutritional properties may vary greatly. Data on the distribution of these species in human blood and their correlation with overall selenium levels are very limited. The concentrations of organic and inorganic selenium species were analyzed in serum of fifty subjects sampled from the general population of the municipality of Modena, northern Italy, aged from 35 to 70 years. Samples were collected during a 30-month period, and determinations of selenium species were carried out using high pressure liquid chromatography coupled with inductively coupled plasma dynamic reaction cell mass spectrometry. The majority of selenium was found to be present as organic species, but the inorganic forms showed higher levels than expected. These species showed limited correlations with age, sex and body mass index, while the organic forms increased in subjects consuming selenium-containing dietary supplements and decreased in smokers. The length of the sample storage period strongly influenced the distribution of selenium compounds, with a clear tendency towards higher inorganic and lower organic selenium levels over time. In multivariate analysis adjusting for potential confounders, total serum selenium correlated with human serum albumin-bound selenium and, in males, with two organic species of the metalloid (selenocysteine and glutathione peroxidase-bound selenium), while little association existed with the other organic forms and the inorganic ones. These findings highlight the potential for exposure misclassification of observational epidemiologic investigations based on overall selenium content in blood and possibly other tissues, and the critical role of the storage conditions for speciation analysis.

A prevention program for multiple health-compromising behaviors in adolescence: baseline results from a cluster randomized controlled trial.

OBJECTIVE: To describe the design and present the baseline findings of the evaluation study of 'Paesaggi di Prevenzione', a school-based prevention program tackling smoking, alcohol misuse, dietary risks, and physical inactivity in 12- to 14-year-olds. METHODS: The program was implemented from January 2011 to April 2012 in Emilia-Romagna, Italy, and comprised classroom activities and school-wide policies. A two-arm cluster randomized controlled trial was designed. Schools were the units of randomization and were matched by socioeconomic status, size, and type. RESULTS: Data from 4700 middle school students and 2952 high school students were collected anonymously from October to December 2010. Past-30-day smoking prevalence was 1.9% among middle school students and 20.8% among high school students. Past-30-day prevalence of alcohol intoxication was 2.2% among middle school students and 11.4% among high school students. A total of 39.7% of middle school students and 48.0% of high school students drank sugar-sweetened beverages four or more times per week; 7.5% of middle school students and 7.1% of high school students had intense physical activity every day. CONCLUSIONS: This study seems adequately powered and baseline variables appear evenly distributed between study groups. Findings are in line with those of the WHO Health Behaviour in School-Aged Children study.

Effectiveness of a school-based multi-component smoking prevention intervention: the LdP cluster randomized controlled trial.

OBJECTIVE: We assessed the effectiveness of the Luoghi di Prevenzione-Prevention Grounds school-based smoking prevention programme. METHODS: We undertook a cluster randomized controlled trial of 989 students aged 14-15 years in 13 secondary schools located in Reggio Emilia, Italy. The intervention consisted of the "Smoking Prevention Tour" (SPT) out-of-school workshop, one in-depth lesson on one Smoking Prevention Tour topic, a life-skills peer-led intervention, and enforcement surveillance of school antismoking policy. Self-reported past 30-day smoking of ≥ 20 or 1-19 days of cigarette smoking (daily or frequent smoking, respectively) was recorded in 2 surveys administered immediately before and 18 months after the beginning of the programme. Analysis was by intention to treat. The effect of the intervention was evaluated using random effects logistic regression and propensity score-matching analyses. RESULTS: Past 30-day smoking and daily cigarette use at eighteen months follow-up were 31% and 46% lower, respectively, for intervention students compared to control students. Taking into account non-smokers at baseline only, daily smoking at eighteen months follow-up was 59% lower in intervention students than in controls. Past 30-day smoking in school areas was 62% lower in intervention students compared to controls. CONCLUSIONS: The Luoghi di Prevenzione-Prevention Grounds programme was effective in reducing daily smokers and in reducing smoking in school areas.

A school-based peer-led smoking prevention intervention with extracurricular activities: the LILT-LdP cluster randomized controlled trial design and study population.

AIMS AND BACKGROUND: Few school programs are effective in preventing adolescents' tobacco smoking initiation. The "Lega contro i Tumori - Luoghi di Prevenzione" is a cluster randomized controlled trial designed to evaluate a school-based peer-led smoking prevention intervention with extracurricular activities for students aged 14-15 years. This paper presents the study design and the baseline characteristics of the study population. METHODS AND STUDY DESIGN: Twenty secondary schools located in the Reggio Emilia province took part in the study. Five schools were excluded because they already participated in smoking prevention interventions. The schools were randomized to control or intervention arms. The study population consisted of students attending the first grade. Components of the intervention included 1) the out-of-school "Smoking Prevention Tour" (SPT) at the "Luoghi di Prevenzione" Center, a 4-hour (4 sessions) extracurricular activity; 2) the "Smoke-free Schools" intervention, combining a life-skills-based peer-led intervention at school, an in-depth lesson on one of the SPT sessions, and enforcement surveillance of the school antismoking policy. Tobacco use was studied through a questionnaire administered before and 6 months after the intervention. RESULTS: Eleven high schools and 9 vocational secondary schools took part in the study for a total of 2,476 out of 3,050 eligible students (81.2%). The proportions of respondents in high schools and vocational secondary schools were 90.9% and 64.5%, respectively (P <0.001). Intervention and control arms showed a different distribution of gender and school type, whereas no difference was observed in any tobacco-use characteristic. CONCLUSIONS: This study is one of the few Italian trials to evaluate the effectiveness of a school-based program for preventing smoking initiation.

Pediatrician-led motivational interviewing to treat overweight children: an RCT.

OBJECTIVE: The aim of this study was to evaluate the effect of family pediatrician-led motivational interviews (MIs) on BMI of overweight (85th ≥ BMI percentile ≥ 95 th) children aged 4 to 7 years. METHODS: All the family pediatricians working in Reggio Emilia Province (Italy) were invited to participate in the study; 95% accepted. Specific training was provided. Parents were asked to participate in the trial if they recognized their child as overweight. Children were individually randomly assigned to MIs or usual care. All children were invited for a baseline and a 12-month visit to assess BMI and lifestyle behaviors. The usual care group received an information leaflet, and the intervention group received 5 MI family meetings. The primary outcome was the individual variation of BMI, assessed by pediatricians unblinded to treatment groups. RESULTS: Of 419 eligible families, 372 (89%) participated; 187 children were randomized to MIs and 185 to the usual care group. Ninety-five percent of the children attended the 12-month visit. The average BMI increased by 0.49 and 0.79 during the intervention in the MI and control groups, respectively (difference: -0.30; P = .007). MI had no effect in boys or in children whose mothers had a low educational level. Positive changes in parent-reported lifestyle behaviors occurred more frequently in the MI group than in the control group. CONCLUSIONS: The pediatrician-led MI was overall effective in controlling BMI in these overweight children aged 4 to 7 years, even though no effect was observed in male children or when the mother's education level was low.