Effectiveness of a Smartphone App (MINISTOP 2.0) integrated in primary child health care to promote healthy diet and physical activity behaviors and prevent obesity in preschool-aged children: randomized controlled trial.

BACKGROUND: Childhood overweight and obesity is a public health priority. We have previously reported the efficacy of a parent-oriented mobile health (mHealth) app-based intervention (MINISTOP 1.0) which showed improvements in healthy lifestyle behaviors. However, the effectiveness of the MINISTOP app in real-world conditions needs to be established. OBJECTIVE: To evaluate the real-world effectiveness of a 6-month mHealth intervention (MINISTOP 2.0 app) on children's intake of fruits, vegetables, sweet and savory treats, sweet drinks, moderate-to-vigorous physical activity, and screen time (primary outcomes), and on parental self-efficacy (PSE) for promoting healthy lifestyle behaviors, and children's body mass index (BMI) (secondary outcomes). METHODS: A hybrid type 1 effectiveness-implementation design was utilized. For the effectiveness outcomes, a two-arm, individually randomized controlled trial was conducted. Parents (n = 552) of 2.5-to-3-year-old children were recruited from 19 child health care centers across Sweden, and, randomized to either a control (standard care) or intervention group (MINISTOP 2.0 app). The 2.0 version was adapted and translated into English, Somali and Arabic to increase reach. All recruitment and data collection were conducted by the nurses. Outcomes were assessed at baseline and after six months, using standardized measures (BMI) and a questionnaire (health behaviors, PSE). RESULTS: Among the participating parents (n = 552, age: 34.1 ± 5.0 years), 79% were mothers and 62% had a university degree. Twenty-four percent (n = 132) of children had two foreign-born parents. At follow-up, parents in the intervention group reported lower intakes of sweet and savory treats (-6.97 g/day; p = 0.001), sweet drinks (-31.52 g/day; p < 0.001), and screen time (-7.00 min/day; p = 0.012) in their children compared to the control group. The intervention group reported higher total PSE (0.91; p = 0.006), PSE for promoting healthy diet (0.34; p = 0.008) and PSE for promoting physical activity behaviors (0.31; p = 0.009) compared to controls. No statistically significant effect was observed for children's BMI z-score. Overall, parents reported high satisfaction with the app, and 54% reported using the app at least once a week. CONCLUSION: Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) and their parents reported higher PSE for promoting healthy lifestyle behaviors. Our results from this real-world effectiveness trial support the implementation of the MINISTOP 2.0 app within Swedish child health care. TRIAL REGISTRATION: Clinicaltrials.gov NCT04147039; https://clinicaltrials.gov/ct2/show/NCT04147039.

mHealth intervention for multiple lifestyle behaviour change among high school students in Sweden (LIFE4YOUth): protocol for a randomised controlled trial.

BACKGROUND: National surveys in Sweden demonstrate that the majority of young people do not engage in health promoting behaviours at levels recommended by the Public Health Agency of Sweden. The objective of this study is to estimate the effectiveness of a novel mHealth intervention named LIFE4YOUth, which targets multiple lifestyle behaviours (alcohol, diet, physical activity, and smoking) among high school students in Sweden. METHODS: A 2-arm parallel groups single blind randomised controlled trial (1:1) will be employed to estimate the effectiveness of the novel mHealth intervention. Students will be recruited at high schools throughout Sweden, and will be included if they fulfil one of six criteria relating to unhealthy behaviours with respect to alcohol, diet, physical activity and smoking. Eligible participants will be randomised to either receive the novel intervention immediately, or to be placed on a waiting list for 4 months. The intervention consists of a combination of recurring screening, text messages, and an interactive platform which is adaptable to individual preferences. Outcome measures with respect to alcohol, diet, physical activity and smoking will be assessed through questionnaires at 2 and 4 months post randomisation. DISCUSSION: The findings of this trial could be generalised to a diverse high-school student population as our recruitment encompass a large proportion of schools throughout Sweden with various educational profiles. Furthermore, if effective, the mHealth intervention has good potential to be able to be scaled up and disseminated at high schools nationally. TRIAL REGISTRATION: Registered prospectively on 2020-05-20 in ISRCTN ( ISRCTN34468623 ).

Cardiorespiratory fitness, muscular strength, and obesity in adolescence and later chronic disability due to cardiovascular disease: a cohort study of 1 million men.

AIMS: Cardiorespiratory fitness, muscular strength, and obesity in adulthood are risk factors for cardiovascular disease (CVD). However, little is known regarding the associations of these risk factors, already in adolescence, with later disability due to chronic CVD. Hence, we investigated associations of cardiorespiratory fitness, muscular strength, and body mass index (BMI) in adolescence with later chronic disability due to specific causes of CVD disability (i.e. cerebrovascular disease, ischaemic heart disease and heart failure). METHODS AND RESULTS: This population-based cohort study included 1 078 685 male adolescents (16-19 years) from the Swedish military conscription register from 1972 to 1994. Cardiorespiratory fitness (bicycle ergometer test), muscular strength (knee extension strength), and BMI were measured during the conscription examination. Information about disability pension due to CVD was retrieved from the Social Insurance Agency during a mean follow-up of 28.4 years. Cardiorespiratory fitness was strongly and inversely associated with later risk of chronic CVD disability for all investigated causes. The association was particularly strong for ischaemic heart diseases (hazard ratio 0.11, 95% confidence interval 0.05-0.29 for highest vs. lowest fitness-quintiles). Furthermore, overweight/obesity were associated with CVD disability for all investigated causes. Conversely, associations of muscular strength with CVD disability were generally weak. CONCLUSIONS: This study provides evidence for associations between low levels of cardiorespiratory fitness and obesity with later risk of chronic disability due to CVD. Preventive actions may begin at young ages and include promotion of cardiorespiratory fitness and healthy body weight.

MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study.

BACKGROUND: Childhood obesity is still a major health problem in many countries, including Sweden. Childhood obesity and obesity-related behaviours in childhood, such as low physical activity and unhealthy eating habits, tend to track into adulthood, which highlights the need for early prevention. Our aims are to evaluate whether a parent-oriented mobile health app (the MINISTOP 2.0 app) integrated into primary child health care can improve diet and physical activity behaviours and reduce the prevalence of overweight and obesity in preschool-aged children as well as to evaluate the implementation among child health care nurses and parents. METHODS: This trial uses a hybrid type 1 effectiveness-implementation design. Families (n = 500) who attend a routine visit to one of 15-20 primary child health care centres throughout Sweden, when their child is 2.5 years, are offered participation in a randomised controlled trial (effectiveness evaluation). After acceptance, families will be randomised (1:1) to control or intervention groups. The intervention group receives a 6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care. Dietary habits, physical activity and screen time (primary outcomes), body weight and height in children, and parental self-efficacy (secondary outcomes) are measured at baseline and at 6 months post randomisation. Implementation outcomes (i.e. perceived acceptability, appropriateness, and feasibility) of the intervention will be assessed among primary child health care nurses and parents in the trial through questionnaires and qualitative interviews. DISCUSSION: This trial will evaluate whether the MINISTOP 2.0 app can be used in primary child health care to improve diet and physical activity behaviours, and prevent overweight and obesity, in preschool-aged children. If effectiveness is proven, and the MINISTOP 2.0 app is considered acceptable, appropriate and feasible, it can be implemented nationally as part of the preventive strategies to combat childhood obesity provided by routine child health care. TRIAL REGISTRATION: The trial was registered at the Clinicaltrials.gov register platform (ID NCT04147039 ) on 31 October 2019.

Hip and wrist accelerometers showed consistent associations with fitness and fatness in children aged 8-12 years.

AIM: Physical activity (PA) has traditionally been measured wearing accelerometers on the hip, but they are increasingly being worn on the wrist. We compared hip and wrist accelerometers with regard to their acceptability and any associations between PA and fatness and fitness. METHODS: This cross-sectional study comprised 103 children aged 8-12 years (62% boys) who participated in the ActiveBrains trial by the University of Granada, Spain, in 2014-2016. The children wore both ActiGraph GT3X+ hip and wrist accelerometers round the clock for 7 days. The acceptability of both placements was evaluated by a questionnaire, while the children's fat mass index, waist circumference and cardiorespiratory fitness (CRF) were assessed. RESULTS: Wearing wrist accelerometers caused less disturbance, mainly because hip accelerometers caused more issues during the night. The measurements from both placements showed that lower PA levels were associated with fatness and that higher PA levels were associated with better CRF. CONCLUSION: Both placements showed consistent results with regard to measuring associations between PA levels and fatness and fitness. However, wearing them on the wrist caused less discomfort at night. Future studies are needed to confirm the best placement for accelerometers during PA studies.

Fitness and Body Mass Index During Adolescence and Disability Later in Life: A Cohort Study.

Background: Low physical fitness, obesity, and the combination of the two in adolescence may be related to risk for disability in adulthood, but this has rarely been studied. Objective: To examine individual and combined associations of cardiorespiratory fitness and obesity in male adolescents with later receipt of a disability pension due to all and specific causes. Design: Population-based cohort study. Setting: Sweden. Participants: 1 079 128 Swedish adolescents aged 16 to 19 years who were conscripted into the military between 1972 and 1994. Measurements: Cardiorespiratory fitness and body mass index (BMI) were measured at conscription and were related to information on later receipt of a disability pension obtained from the Social Insurance Agency. Results: Over a median follow-up of 28.3 years, 54 304 men were granted a disability pension. Low cardiorespiratory fitness was strongly associated with later receipt of a disability pension due to all causes (hazard ratio, 3.74 [95% CI, 3.55 to 3.95] for lowest vs. highest fitness decile) and specific causes (psychiatric, musculoskeletal, injuries, nervous system, circulatory, and tumors). Obesity was associated with greater risk for receipt of a disability pension due to all and specific causes, with the greatest risks observed for class II and III obesity. Compared with being unfit, being moderately or highly fit was associated with attenuated risk for receipt of a disability pension across BMI categories. Limitation: The cohort did not include women, had data on smoking and alcohol intake only in a subsample, and lacked repeated measures of exposures and covariates. Conclusion: Low cardiorespiratory fitness, obesity, and the combination of the two were strongly associated with later chronic disability due to a wide range of diseases and causes. Although additional well-designed studies are required, these findings support the importance of high cardiorespiratory fitness and healthy body weight during adolescence to prevent later chronic disease. Primary Funding Source: Karolinska Institutet.

Dietary determinants of hepatic fat content and insulin resistance in overweight/obese children: a cross-sectional analysis of the Prevention of Diabetes in Kids (PREDIKID) study.

Paediatric non-alcoholic fatty liver disease has increased in parallel with childhood obesity. Dietary habits, particularly products rich in sugars, may influence both hepatic fat and insulin resistance (homeostatic model assessment for insulin resistance (HOMA-IR)). The aim of the study was to examine the association of the consumption of foods and food components, dairy desserts and substitutes (DDS), sugar-sweetened beverages (SSB), as well as total and added sugars, with hepatic fat and HOMA-IR. Dietary intake (two non-consecutive 24 h-recalls), hepatic fat (MRI) and HOMA-IR were assessed in 110 overweight/obese children (10·6 (sd 1·1) years old). Linear regression analyses were used to examine the association of dietary intake with hepatic fat and HOMA-IR adjusted for potential confounders (sex, age, energy intake, maternal educational level, total and abdominal adiposity and sugar intake). The results showed that there was a negative association between cereal intake and hepatic fat (ß=-0·197, P<0·05). In contrast, both SSB consumption (ß=0·217; P=0·028) and sugar in SSB (ß=0·210, P=0·035), but not DDS or sugar in DDS or other dietary components, were positively associated with hepatic fat regardless of potential confounders including total sugar intake. In conclusion, cereal intake might decrease hepatic fat, whereas SSB consumption and its sugar content may increase the likelihood of having hepatic steatosis. Although these observations need to be confirmed using experimental evidence, these results suggest that healthy lifestyle intervention programs are needed to improve dietary habits as well as to increase the awareness of the detrimental effects of SSB consumption early in life.

Muscular weakness in adolescence is associated with disability 30 years later: a population-based cohort study of 1.2 million men.

OBJECTIVE: To investigate the associations of muscular strength in adolescence with later disability pension (DP), across different body mass index (BMI) categories and in combination with aerobic fitness. METHOD: This prospective cohort study consisted of males aged 16-19 years, recruited from the Swedish military conscription register between 1969 and 1994. A total of 1 212 503 adolescents met all the inclusion criteria and were therefore included in the analyses. Knee extension, handgrip and elbow flexion strength and aerobic fitness (bicycle ergometer test) were measured during conscription. Causes of DP were retrieved from the Social Insurance Office between years 1971 and 2012 (average follow-up time: 29.6 years). RESULTS: Knee extension strength in adolescence was inversely associated with men's risk of obtaining DP due to all causes (HR 1.40, 95% CI 1.36 to 1.44 for lowest vs highest strength quintile). Thus, muscular weakness was associated with DP. The risk associated with low muscular strength differed between specific causes of DP and the strongest associations were found for psychiatric, nervous system and other causes (HRs between 1.47 and 1.90 for lowest vs highest quintile). Being strong was associated with lower DP risk across BMI categories and being unfit, weak and obese was associated with the highest DP risk (HR 3.70, 95% CI 2.99 to 4.58). CONCLUSION: There was a strong association between muscular weakness and disability. A combination of muscular weakness and low aerobic fitness was an especially important risk factor for disability. This adds weight to call for muscular strength and fitness enhancing exercise for adolescents in all BMI categories.

The paediatric option for BodPod to assess body composition in preschool children: what fat-free mass density values should be used?

Air displacement plethysmography utilises a two-component model to assess body composition, which relies on assumptions regarding the density of fat-free mass (FFM). To date, there is no evidence as to whether Lohman's or Wells et al.'s FFM density values are more accurate in young children. Therefore, the aims of this study were to compare total body fat percentage (TBF%) assessed using the BodPod with both Lohman's and Wells et al.'s FFM density values with TBF% from the three-component (3C) model in forty healthy Swedish children aged 5·5 years. Average TBF% calculated using Lohman's FFM density values underestimated TBF% in comparison with the corresponding value assessed using the 3C model (22·2 (sd 5·7) and 25·1 (sd 5·5) %, respectively; P<0·001). No statistically significant difference was observed between TBF% assessed using Wells et al.'s FFM density values and the 3C model (24·9 (sd 5·5) and 25·1 (sd 5·5) %, respectively; P=0·614). The Bland and Altman plots for TBF% using both Lohman's and Wells et al.'s FFM density values did not show any bias across the range of body fatness (Lohman: r 0·056, P=0·733 and Wells et al.: r -0·006, P=0·970). These results indicate that Wells et al.'s FFM density values should be used when assessing body composition with the paediatric option for BodPod in 5-year-old children. However, future studies are needed to confirm these results in other populations, including a wider age range of children.

A 12-month follow-up of a mobile-based (mHealth) obesity prevention intervention in pre-school children: the MINISTOP randomized controlled trial.

BACKGROUND: To date, few mobile health (mHealth) interventions aimed at changing lifestyle behaviors have measured long term effectiveness. At the 6-month follow-up the MINISTOP trial found a statistically significant intervention effect for a composite score comprised of fat mass index (FMI) as well as dietary and physical activity variables; however, no intervention effect was observed for FMI. Therefore, the aim of this study was to investigate if the MINISTOP intervention 12-months after baseline measurements: (i) improved FMI and (ii) had a maintained effect on a composite score comprised of FMI and dietary and physical activity variables. METHODS: A two-arm parallel randomized controlled trial was conducted in 315 healthy 4.5 year old children between January 2014 and October 2015. Parents' of the participating children either received the MINISTOP intervention or a basic pamphlet on dietary and physical activity behaviors (control group). After 6 months, participants did not have access to the intervention content and were measured again 6 months later (i.e. the 12-month follow-up). The Wilcoxon rank-sum test was then used to examine differences between the groups. RESULTS: At the 12-month follow-up, no statistically significant difference was observed between the intervention and control groups for FMI (p = 0.57) and no maintained effect for the change in composite score was observed (mean ± standard deviation for the intervention and control group: + 0.53 ± 1.49 units and + 0.35 ± 1.27 units respectively, p = 0.25 between groups). CONCLUSIONS: The intervention effect observed at the 6-month follow-up on the composite score was not maintained at the 12-month follow-up, with no effect on FMI being observed at either follow-up. Future studies using mHealth are needed to investigate how changes in obesity related markers in young children can be maintained over longer time periods. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02021786 ; 20 Dec 2013).

Physical Activity Level Using Doubly-Labeled Water in Relation to Body Composition and Physical Fitness in Preschoolers.

Background and objectives: There is a lack of studies investigating associations of physical activity level (PAL) and activity energy expenditure (AEE) using the doubly-labeled water (DLW) method with body composition and physical fitness in young children. Thus, we aimed to examine cross-sectional associations of PAL and AEE with body composition indices and physical fitness components in Swedish preschool children. Materials and methods: PAL was calculated as total energy expenditure measured using DLW divided by the predicted basal metabolic rate in 40 children aged 5.5 (standard deviation 0.2) years. AEE was calculated as total energy expenditure minus basal metabolic rate and the thermic effect of food, and divided by fat-free mass. Body composition was assessed using the 3-component model by combining measurements based on isotope dilution and air-displacement plethysmography. Physical fitness (muscular strength, motor fitness, and cardiorespiratory fitness) was evaluated using the PREFIT test battery. Multiple linear regression models were conducted. Results: PAL and AEE were negatively associated with body mass index, percent body fat, and fat mass index (PAL: standardized ß -0.35, -0.41, and -0.45, all p < 0.036; AEE: standardized ß -0.44, -0.44, and -0.47, all p < 0.006, respectively). Furthermore, PAL and AEE were positively associated with the standing long jump test (PAL: standardized ß 0.37, p = 0.017; AEE: standardized ß 0.38, p = 0.014). There were no statistically significant associations found regarding PAL or AEE with fat-free mass index or any other physical fitness test. Conclusions: Greater PAL and AEE at the age 5.5 were significantly associated with body fatness and improved lower-body muscular strength. Therefore, increasing physical activity, and thus energy expenditure, at young ages may be beneficial for preventing overweight/obesity. However, further studies with larger sample sizes are needed to confirm the results.

Diet quality and attention capacity in European adolescents: the Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA) study.

Adolescence represents an important period for the development of executive functions, which are a set of important cognitive processes including attentional control. However, very little is known regarding the associations of nutrition with components of executive functions in adolescence. Thus, the aim of this study was to investigate associations of dietary patterns and macronutrient composition with attention capacity in European adolescents. This cross-sectional study included 384 (165 boys and 219 girls) adolescents, aged 12·5-17·5 years, from five European countries in the Healthy Lifestyle in Europe by Nutrition in Adolescence study. Attention capacity was examined using the d2 Test of Attention. Dietary intake was assessed through two non-consecutive 24 h recalls using a computer-based self-administered tool. Three dietary patterns (diet quality index, ideal diet score and Mediterranean diet score) and macronutrient/fibre intakes were calculated. Linear regression analysis was conducted adjusting for age, sex, BMI, maternal education, family affluence scale, study centre and energy intake (only for Mediterranean diet score). In these adjusted regression analyses, higher diet quality index for adolescents and ideal diet score were associated with a higher attention capacity (standardised ß=0·16, P=0·002 and ß=0·15, P=0·005, respectively). Conversely, Mediterranean diet score or macronutrient/fibre intake were not associated with attention capacity (P>0·05). Our results suggest that healthier dietary patterns, as indicated by higher diet quality index and ideal diet score, were associated with attention capacity in adolescence. Intervention studies investigating a causal relationship between diet quality and attention are warranted.

A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial.

BACKGROUND: Childhood obesity is an increasing health problem globally. Overweight and obesity may be established as early as 2-5 years of age, highlighting the need for evidence-based effective prevention and treatment programs early in life. In adults, mobile phone based interventions for weight management (mHealth) have demonstrated positive effects on body mass, however, their use in child populations has yet to be examined. The aim of this paper is to report the study design and methodology of the MINSTOP (Mobile-based Intervention Intended to Stop Obesity in Preschoolers) trial. METHODS/DESIGN: A two-arm, parallel design randomized controlled trial in 300 healthy Swedish 4-year-olds is conducted. After baseline measures, parents are allocated to either an intervention- or control group. The 6- month mHealth intervention consists of a web-based application (the MINSTOP app) to help parents promote healthy eating and physical activity in children. MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive, personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children. Parents also register physical activity and intakes of candy, soft drinks, vegetables as well as fruits of their child and receive feedback through the application. Primary outcomes include body fatness and energy intake, while secondary outcomes are time spent in sedentary, moderate, and vigorous physical activity, physical fitness and intakes of fruits and vegetables, snacks, soft drinks and candy. Food and energy intake (Tool for Energy balance in Children, TECH), body fatness (pediatric option for BodPod), physical activity (Actigraph wGT3x-BT) and physical fitness (the PREFIT battery of five fitness tests) are measured at baseline, after the intervention (six months after baseline) and at follow-up (12 months after baseline). DISCUSSION: This novel study will evaluate the effectiveness of a mHealth program for mitigating gain in body fatness among 4-year-old children. If the intervention proves effective it has great potential to be implemented in child-health care to counteract childhood overweight and obesity. TRIAL REGISTRATION: ClinicalTrials.gov NCT02021786 ; 20 Dec 2013.

Evaluation of Actiheart and a 7 d activity diary for estimating free-living total and activity energy expenditure using criterion methods in 1·5- and 3-year-old children.

Accurate and easy-to-use methods to assess free-living energy expenditure in response to physical activity in young children are scarce. In the present study, we evaluated the capacity of (1) 4 d recordings obtained using the Actiheart (mean heart rate (mHR) and mean activity counts (mAC)) to provide assessments of total energy expenditure (TEE) and activity energy expenditure (AEE) and (2) a 7 d activity diary to provide assessments of physical activity levels (PAL) using three sets of metabolic equivalent (MET) values (PALTorun, PALAdolph and PALAinsworth) in forty-four and thirty-one healthy Swedish children aged 1·5 and 3 years, respectively. Reference TEE, PALref and AEE were measured using criterion methods, i.e. the doubly labelled water method and indirect calorimetry. At 1·5 years of age, mHR explained 8 % (P= 0·006) of the variation in TEE above that explained by fat mass and fat-free mass. At 3 years of age, mHR and mAC explained 8 (P= 0·004) and 6 (P= 0·03) % of the variation in TEE and AEE, respectively, above that explained by fat mass and fat-free mass. At 1·5 and 3 years of age, average PALAinsworth values were 1·44 and 1·59, respectively, and not significantly different from PALref values (1·39 and 1·61, respectively). By contrast, average PALTorun (1·5 and 3 years) and PALAdolph (3 years) values were lower (P< 0·05) than the corresponding PALref values. In conclusion, at both ages, Actiheart recordings explained a small but significant fraction of free-living energy expenditure above that explained by body composition variables, and our activity diary produced mean PAL values in agreement with reference values when using MET values published by Ainsworth.

Promoting Healthy Behaviors Among Adolescents and Young Adults With Intellectual Disability: Protocol for Developing a Digital Intervention With Co-Design Workshops.

BACKGROUND: Intellectual disability (ID) is a neurodevelopmental disorder associated with a poorer health profile and higher mortality. Young people with ID have more sedentary lifestyles than their typically developing peers. Consequently, this group is at significant risk of developing lifestyle diseases (ie, noncommunicable diseases) later in life. Increasing physical activity and eating a healthier diet have been argued to be effective ways to improve the health of adolescents and young adults with ID. Digital interventions are a viable option for improving health behaviors. OBJECTIVE: This research protocol describes a co-design approach using workshops to develop a digital intervention that promotes healthy behaviors, including increasing physical activity and eating a healthier diet, among adolescents and young adults with ID. METHODS: A participatory design using a co-design approach will be applied as a strategy to include potential users of the digital intervention and other stakeholders in the research process, comprising research design, data collection, and data analysis. A total of 7 to 10 workshops will be conducted aimed at developing a digital intervention and will include procedures for assessing needs; facilitators and barriers to health promotion; physical, mental, and social well-being; participation; and relationships. The workshops will include 12 to 18 stakeholders with experience of clinical practice and research related to young people with ID, including relatives, as well as adolescents and young adults (aged 16-25 years) with mild to moderate ID. Participants will perform a mixture of individual and group work using whiteboards, sticky notes, felt-tip pens, cards, balls, stickers, and wireframe templates. Data analysis will take place concurrently with data collection as an iterative process. Transcribed data from the audio and video recordings of the groups' discussions will be analyzed following a qualitative methodological procedure. RESULTS: This study protocol provides a systematic record of the scientific methodologies used when developing the digital intervention and provides insights into the potential practical solutions and challenges when following a co-design approach in which relatives and professionals, as well as adolescents and young adults with ID, are included as research partners. Recruitment of participants started in April 2023. Data collection, analysis, and reporting will be completed in December 2023. CONCLUSIONS: This study will explore the effectiveness of workshops at gathering rich, reliable, and valid data in a co-design approach with participants. The results will provide increased knowledge in how to use technology to develop novel, evidence-based, and scalable interventions that adolescents and young adults with ID can and want to use to motivate physical activity and a healthier diet. The project will provide a simple and cognitively accessible digital solution for promoting lifestyle behaviors tailored to the needs of adolescents and young adults with ID. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47877.

Effects of an Exercise Program on Cardiometabolic and Mental Health in Children With Overweight or Obesity: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Childhood obesity is a risk factor associated with type 2 diabetes, cardiovascular disease, and mental disorders later in life. Investigation of the parallel effects of a defined exercise program on cardiometabolic and mental health in children with overweight or obesity may provide new insights on the potential benefits of exercise on overall health. Objective: To investigate the effects of a 20-week exercise program on cardiometabolic and mental health in children with overweight or obesity. Design, Setting, and Participants: This secondary analysis of a parallel-group randomized clinical trial was conducted in Granada, Spain, from November 1, 2014, to June 30, 2016. Data analyses were performed between February 1, 2020, and July 14, 2022. Children with overweight or obesity aged 8 to 11 years were eligible, and the study was performed in an out-of-school context. Intervention: The exercise program included 3 to 5 sessions/wk (90 min/session) of aerobic plus resistance training for 20 weeks. The wait-list control group continued with their usual routines. Main Outcomes and Measures: Cardiometabolic outcomes as specified in the trial protocol included body composition (fat mass, fat-free mass, and visceral adipose tissue), physical fitness (cardiorespiratory, speed-agility, and muscular), and traditional risk factors (waist circumference, blood lipid levels, glucose levels, insulin levels, and blood pressure). Cardiometabolic risk score (z score) was calculated based on age and sex reference values for levels of triglycerides, inverted high-density lipoprotein cholesterol, and glucose, the mean of systolic and diastolic blood pressure, and waist circumference. An additional cardiometabolic risk score also included cardiorespiratory fitness. Mental health outcomes included an array of psychological well-being and ill-being indicators. Results: The 92 participants included in the per-protocol analyses (36 girls [39%] and 56 boys [61%]) had a mean (SD) age of 10.0 (1.1) years. The exercise program reduced the cardiometabolic risk score by approximately 0.38 (95% CI, -0.74 to -0.02) SDs; decreased low-density lipoprotein cholesterol level by -7.00 (95% CI, -14.27 to 0.37) mg/dL (to convert to mmol/L, multiply by 0.0259), body mass index (calculated as weight in kilograms divided by height in meters squared) by -0.59 (95% CI, -1.06 to -0.12), fat mass index by -0.67 (95% CI, -1.01 to -0.33), and visceral adipose tissue by -31.44 (95% CI, -58.99 to -3.90) g; and improved cardiorespiratory fitness by 2.75 (95% CI, 0.22-5.28) laps in the exercise group compared with the control group. No effects were observed on mental health outcomes. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, an aerobic plus resistance exercise program improved cardiometabolic health in children with overweight or obesity but had no effect on mental health. Trial Registration: ClinicalTrials.gov Identifier: NCT02295072.

Mobile phone-based lifestyle support for families with young children in primary health care (MINISTOP 2.0): Exploring behavioral change determinants for implementation using the COM-B model.

Background: Obesity in childhood is a public health concern worldwide and mobile phone-based interventions (mHealth) has shown to facilitate obesity prevention. However, more research is needed on the implementation of digital tools in routine primary care. This study explored behavior change determinants for implementing a health promotion mHealth intervention (MINISTOP 2.0 app) targeting parents of 4-year-olds. Methods: Secondary data from telephone interviews (n = 15) with child health care nurses working within primary child healthcare in Sweden was analyzed using directed content analysis and the COM-B model. Results: Barriers for implementation included: limited knowledge about using technology and reservations about how and to what extent parents would use mHealth. Potential facilitators included nurses' openness to learn and try new tools, confidence in their role and engagement in reaching parents as well as beliefs that the app could improve practice by prompting dialogue and being a shared platform. Nurses expressed a strong professional identity and shared understanding of their practice, mechanisms that could potentially inhibit or facilitate implementation. Conclusions: Findings suggest cautious optimism regarding implementing mobile phone-based tools in child primary healthcare in terms of capability, opportunity and motivation among stakeholders. Implementation strategies such as educational outreach visits and making the intervention testable among stakeholders could further facilitate implementation in this clinical context. However, more research is needed on behavior change determinants in different stages of real-world implementation.

Digital multiple health behaviour change intervention targeting online help seekers: protocol for the COACH randomised factorial trial.

INTRODUCTION: Unhealthy lifestyle behaviours continue to be highly prevalent, including alcohol consumption, unhealthy diets, insufficient physical activity and smoking. There is a lack of effective interventions which have a large enough reach into the community to improve public health. Additionally, the common co-occurrence of multiple unhealthy behaviours demands investigation of efforts which address more than single behaviours. METHODS AND ANALYSIS: The effects of six components of a novel digital multiple health behaviour change intervention on alcohol consumption, diet, physical activity and smoking (coprimary outcomes) will be estimated in a factorial randomised trial. The components are designed to facilitate behaviour change, for example, through goal setting or increasing motivation, and are either present or absent depending on allocation (ie, six factors with two levels each). The study population will be those seeking help online, recruited through search engines, social media and lifestyle-related websites. Included will be those who are at least 18 years of age and have at least one unhealthy behaviour. An adaptive design will be used to periodically make decisions to continue or stop recruitment, with simulations suggesting a final sample size between 1500 and 2500 participants. Multilevel regression models will be used to analyse behavioural outcomes collected at 2 months and 4 months postrandomisation. ETHICS AND DISSEMINATION: Approved by the Swedish Ethical Review Authority on 2021-08-11 (Dnr 2021-02855). Since participation is likely motivated by gaining access to novel support, the main concern is demotivation and opportunity cost if the intervention is found to only exert small effects. Recruitment began on 19 October 2021, with an anticipated recruitment period of 12 months. TRIAL REGISTRATION NUMBER: ISRCTN16420548.

Adapting a Parental Support App to Promote Healthy Diet and Physical Activity Behaviors (MINISTOP) for a Multi-Ethnic Setting: A Qualitative Study on the Needs and Preferences of Parents and Nurses within Swedish Child Health Care.

Early efforts for prevention of childhood overweight and obesity are needed. In order to adapt an app promoting healthy diet and physical activity behaviors in children (MINISTOP 1.0) for multi-ethnic communities, we explored: (1) needs and concerns among Somali-, Arabic-, and Swedish-speaking parents in terms of supporting healthy diet and activity behaviors in their children; (2) nurses' perceptions of parental needs and concerns in relation to diet and physical activity behaviors; and (3) how the features and content of the MINISTOP 1.0 app could be refined to better support health behaviors in children, among both parents and nurses. Focus groups with Somali-, Arabic-, and Swedish-speaking parents (n = 15), and individual interviews with nurses (n = 15) were conducted. Parents expressed several challenges in supporting children's health behaviors, the need for a tailored app, and alternative ways of accessing the content (audio/video). Nurses emphasized the need of supporting parents early, and the value of a shared platform in different languages, to facilitate communication. This study contributes valuable insights about parental needs and relevant adaptations to a parental support app, such as addition of audio/video files for increased accessibility. This adapted app version-MINISTOP 2.0, can be useful for childhood obesity prevention in multi-ethnic communities.