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Effect of a Multicomponent mHealth Intervention on the Composition of Diet in a Population with Overweight and Obesity-Randomized Clinical Trial EVIDENT 3.
Lugones-Sánchez, C, Recio-Rodríguez, JI, Menéndez-Suárez, M, Saz-Lara, A, Ramirez-Manent, JI, Sánchez-Calavera, MA, Gómez-Sánchez, L, Rodríguez-Sánchez, E, García-Ortiz, L, Evident Investigators Group,
Nutrients. 2022;(2)
Abstract
A balanced diet can help in the prevention of chronic diseases. The aim of this study was to evaluate the effect of an mHealth intervention on the distribution of macronutrients and the intake of food groups. A total of 650 participants were included in this multi-center, clinical, randomized, controlled trial (Evident 3 study). All participants were given brief advice about diet and exercise. The intervention group received, in addition, an app (Evident 3) for the self-recording of their diet and an activity tracker wristband for 3 months. Follow-up visits were performed at 3 and 12 months to collect the diet composition using the Food Frequency Questionnaire. There were decreases in the intake of total calories, fat, protein and carbohydrates in both groups throughout the study, without significant differences between them. The intervention group reduced the intake of cholesterol (-30.8; 95% CI -59.9, -1.7) and full-fat dairies (-23.3; 95% CI -42.8, -3.8) and increased the intake of wholemeal bread (3.3; 95% CI -6.7, 13.3) and whole-grain cereals (3.4; 95% CI -6.8, 13.7) with respect to the control group. No differences were found in the rest of the nutritional parameters. The brief advice is useful to promote a healthier diet, and the app can be a support tool to obtain changes in relevant foods, such as integral foods, and the intake of cholesterol. Trial registration: ClinicalTrials.gov with identifier NCT03175614.
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Personalized eHealth Program for Life-style Change: Results From the "Do Cardiac Health Advanced New Generated Ecosystem (Do CHANGE 2)" Randomized Controlled Trial.
Broers, ER, Widdershoven, J, Denollet, J, Lodder, P, Kop, WJ, Wetzels, M, Ayoola, I, Piera-Jimenez, J, Habibović, M, ,
Psychosomatic medicine. 2020;(4):409-419
Abstract
OBJECTIVE Unhealthy life-style factors have adverse outcomes in cardiac patients. However, only a minority of patients succeed to change unhealthy habits. Personalization of interventions may result in critical improvements. The current randomized controlled trial provides a proof of concept of the personalized Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) 2 intervention and evaluates effects on a) life-style and b) quality of life over time. METHODS Cardiac patients (n = 150; mean age = 61.97 ± 11.61 years; 28.7% women; heart failure, n = 33; coronary artery disease, n = 50; hypertension, n = 67) recruited from Spain and the Netherlands were randomized to either the "Do CHANGE 2" or "care as usual" group. The Do CHANGE 2 group received ambulatory health-behavior assessment technologies for 6 months combined with a 3-month behavioral intervention program. Linear mixed-model analysis was used to evaluate the intervention effects, and latent class analysis was used for secondary subgroup analysis. RESULTS Linear mixed-model analysis showed significant intervention effects for life-style behavior (Finteraction(2,138.5) = 5.97, p = .003), with improvement of life-style behavior in the intervention group. For quality of life, no significant main effect (F(1,138.18) = .58, p = .447) or interaction effect (F(2,133.1) = 0.41, p = .67) was found. Secondary latent class analysis revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible. CONCLUSIONS The personalized eHealth intervention resulted in significant improvements in life-style. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioral intervention program. Incorporating eHealth life-style programs as part of secondary prevention would be particularly useful when taking into account which patients are most likely to benefit. TRIAL REGISTRATION https://clinicaltrials.gov/ct2/show/NCT03178305.
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Association of Multisetting Community Programs and Policies With Child Body Mass Index: The Healthy Communities Study.
Collie-Akers, VL, Fawcett, SB, Schultz, JA, Fleming, KK, Swinburne Romine, RE, Ritchie, LD, Frongillo, EA, Arteaga, SS
Preventing chronic disease. 2020;:E34
Abstract
INTRODUCTION Expert opinion suggests that efforts to address childhood obesity should seek to transform the environments in which children operate. The objective of this study was to describe the extent to which multisetting programs and policies interact with community and child predictors and are associated with child body mass index (BMI) in the 130 US communities participating in the Healthy Communities Study. METHODS For 2 years beginning in fall 2013, we collected data through key informant interviews on community programs and policies related to healthy weight among children that occurred in the 10 years before the interview. We characterized community programs and policies by intensity of efforts and the number of settings in which a program or policy was implemented. Child height and weight were measured during household data collection. We used multilevel modeling to examine associations of community programs and policies in multiple settings and child and community predictors with BMI z scores of children. RESULTS The mean number of settings in which community policies and programs were implemented was 7.3 per community. Of 130 communities, 31 (23.8%) implemented community programs and policies in multiple settings. Higher-intensity community programs and policies were associated with lower BMI in communities that used multiple settings but not in communities that implemented programs and policies in few settings. CONCLUSION Efforts to prevent childhood obesity may be more effective when community programs and policies are both intensive and are implemented in multiple settings in which children live, learn, and play.
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Short-Term Effects of an Obesity Prevention Program Among Low-Income Hispanic Families With Preschoolers.
Hughes, SO, Power, TG, Beck, A, Betz, D, Goodell, LS, Hopwood, V, Jaramillo, JA, Lanigan, J, Martinez, AD, Micheli, N, et al
Journal of nutrition education and behavior. 2020;(3):224-239
Abstract
OBJECTIVE To assess the short-term effects of an obesity prevention program promoting eating self-regulation and healthy food preferences in low-income Hispanic children. DESIGN Randomized controlled trial with pretest, posttest, and 6- and 12-month assessments. SETTING AND PARTICIPANTS Head Start and similar early learning institutions in Houston, TX, and Pasco, WA. A total of 255 families with preschoolers randomized into prevention (n = 136) and control (n = 119) groups. INTERVENTION Multicomponent family-based prevention program. Fourteen waves lasted 7 weeks each with 8-10 mother-child dyads in each group. MAIN OUTCOME MEASURES Parent assessments included feeding practices, styles, and knowledge. Child assessments included child eating self-regulation, willingness to try new foods, and parent report of child fruit and vegetable preferences. Parent and child heights and weights were measured. ANALYSIS Multilevel analyses were employed to consider the nested nature of the data: time points within families within waves. RESULTS The program had predicted effects on parental feeding practices, styles, and knowledge in the pre- to post-comparisons. Effects on child eating behavior were minimal; only the number of different vegetables tried showed significant pre-post differences. CONCLUSIONS AND IMPLICATIONS Short-term effects of this prevention program highlight the importance of family-focused feeding approaches to combating child overweight and obesity.
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Effect of a 30-Month Health-Promoting Program on the Prevalence of Cardiovascular Risk Factors in Patients With First Episode Schizophrenia.
Søgaard, HJ, Højlund, M, Elliott, A, Viuff, AG, Vandborg, K, Viuff, J, Munk-Jørgensen, P, Hjorth, P
American journal of therapeutics. 2020;(5):e439-e449
Abstract
BACKGROUND Lifestyle interventions aimed at reducing cardiovascular risk factors in patients with first-episode schizophrenia (FES) have shown modest efficacy, probably owing to a short observation period and the presumption of linear trajectories of cardiovascular risk factors. STUDY QUESTION How prevalent are abnormal cardiovascular values in patients with FES and how do cardiovascular risk factors develop during a 30-month program? STUDY DESIGN A 30-month naturalistic longitudinal study of 136 consecutively referred patients with FES from 2 outpatient clinics. The health-promoting program consisted of individual guidance, group sessions, and normal treatment and care. MEASURES AND OUTCOMES The prevalence of abnormal cardiovascular risk factors (body mass index, waist circumference (WC), body fat percentage, systolic and diastolic blood pressure, pulse, total cholesterol, high- and low-density lipoproteins, triglycerides, mean glucose, and visceral adiposity index) was estimated at index. The cardiovascular risk factor trajectories were analyzed with longitudinal mixed-effect models. RESULTS The patient with FES showed elevated cardiovascular risk factors at index. Thus, 56.8% of the patients were overweight in different grades and 50.4% had increased WC. A total of 81.8% had high level of body fat and hypertension prevalence with only 20% with normal blood pressure. Important changes during the intervention period were that the risk factors weight and WC were increasing the first 581 and 646 days, after which they decreased. Almost all cardiovascular risk factors worsened initially, improving after 1-2 years. CONCLUSIONS Patients with FES show increases in cardiovascular risk factors at index. Short observation periods and the presumption of linear trajectories may indicate that the effect of health-promoting programs is ineffective, as the effects are curvilinear and improvements appear only after 1 year. The implication clinically is the importance of a long intervention period regarding lifestyle modifications to ascertain improvement among patients with FES.
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Development of a subset of ICNP Nursing Diagnoses for the promotion of self-care in people with diabetes mellitus: a multi-center observational study.
Bezze, S, Ausili, D, Erba, I, Redini, S, Re, S, Di Mauro, S
Annali di igiene : medicina preventiva e di comunita. 2020;(1):38-49
Abstract
INTRODUCTION Self-care is a key for people with diabetes mellitus (DM) to avoid severe complications and to maintain quality of life. Person-centered and accurate nursing care plans can help nurses to deliver effective self-care promotion interventions. Few studies focused on nursing diagnoses that are specific for diabetes self-care education, and none of them used the International Classification for Nursing Practice (ICNP). International Catalogues of ICNP nursing diagnoses are missing in this field. AIMS To identify the ICNP nursing diagnoses that are useful to promote self-care in people with DM; to describe the prevalence of ICNP nursing diagnoses in self-care of people with DM. METHODS A subset of 55 ICNP nursing diagnoses was developed based on the Middle Range Theory of Self-care of Chronic Illness, and most recent diabetes clinical guidelines. Then, the subset was tested through a multicenter cross-sectional design involving a consecutive sample of 170 adults with confirmed diagnosis of Type 1 or Type 2 DM. Data were collected by medical records, physical examinations and semi-structured interviews. RESULTS 1343 nursing diagnoses were identified, with an average of 8 nursing diagnoses per patient. The 100% of the nursing diagnoses were described using the pre-developed subset. Overall, the five prevalent nursing diagnoses were: Body weight problem (56.4%), Non adherence to immunization regime (53.5%), Conflicting attitude toward dietary regime (41.7%), Impaired weight monitoring (39.4%), and Lack of knowledge about blood glucose diagnostic test result (32.3%). Nursing diagnoses by self-care maintenance, monitoring and management were also described. CONCLUSIONS A huge amount of nursing diagnoses was identified suggesting the need of intensive education. Clinicians and administrators can use this subset to improve the accuracy of the documentation of diabetes care. In Public Health, the subset can be used to assess the cost-effectiveness of diabetes healthcare services. Future research is needed to assess the effectiveness of this subset in settings that are different from the one where it was developed. Finally, this subset could be a starting point to develop and International ICNP Catalogue for diabetes care.
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Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial.
Puigdomenech, E, Martin, A, Lang, A, Adorni, F, Gomez, SF, McKinstry, B, Prinelli, F, Condon, L, Rashid, R, Caon, M, et al
BMC medical informatics and decision making. 2019;(1):278
Abstract
BACKGROUND Behaviour change interventions targeting physical activity, diet, sleep and sedentary behaviour of teenagers show promise when delivered through smartphones. However, to date there is no evidence of effectiveness of multicomponent smartphone-based interventions. Utilising a user-centred design approach, we developed a theory-based, multi-dimensional system, PEGASO Fit For Future (PEGASO F4F), which exploits sophisticated game mechanics involving smartphone applications, a smartphone game and activity sensors to motivate teenagers to take an active role in adopting and maintaining a healthy lifestyle. This paper describes the study protocol to assess the feasibility, usability and effectiveness (knowledge/awareness and behavioural change in lifestyle) of the PEGASO system. METHODS We are conducting a quasi-experimental controlled cluster trial in 4 sites in Spain, Italy, and UK (England, Scotland) over 6 months. We plan to recruit 525, in a 2:1 basis, teenagers aged 13-16 years from secondary schools. The intervention group is provided with the PEGASO system whereas the comparison group continues their usual educational routine. Outcomes include feasibility, acceptance, and usability of the PEGASO system as well as between and within group changes in motivation, self-reported diet, physical activity, sedentary and sleeping behaviour, anthropometric measures and knowledge about a healthy lifestyle. DISCUSSION PEGASO F4F will provide evidence into the cross-cultural similarities and differences in the feasibility, acceptability and usability of a multi-dimensional smartphone based behaviour change intervention for teenagers. The study will explore facilitating factors, challenges and barriers of engaging teenagers to adapt and maintain a healthy lifestyle when using smartphone technology. Positive results from this ICT based multi component intervention may have significant implications both at clinical level, improving teenagers health and at public health level since it can present an influential tool against the development of chronic disease during adulthood. TRIAL REGISTRATION https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.
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CHAMP: A cluster randomized-control trial to prevent obesity in child care centers.
Armstrong, B, Trude, ACB, Johnson, C, Castelo, RJ, Zemanick, A, Haber-Sage, S, Arbaiza, R, Black, MM
Contemporary clinical trials. 2019;:105849
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Foundational elements of lifelong health are formed during the preschool years. Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity. Despite the promising evidence of efficacy of child care-based obesity prevention interventions, limited attention has been directed to criteria needed for implementation at scale. There is potential to improve children's dietary and physical activity behaviors in diverse communities through theory-based, culturally appropriate, manualized interventions, delivered by child care staff. CHAMP (Creating Healthy Habits Among Maryland Preschoolers) is a 3-arm cluster randomized controlled childhood obesity prevention trial, aiming to improve motor skills, physical activity and willingness to try new foods among 864 preschoolers (age 3-5 years) enrolled in 54 child care centers in 10 Maryland counties. CHAMP is informed by social-cognitive and bioecological theories and based on an evidence-based program, The Food Friends®. The two intervention arms include: 1) child care-center based lessons (18-week gross motor and 12-week nutrition) administered by trained child care staff, and 2) a web-based intervention for caregivers in addition to center-based lessons. Evaluations are conducted among children, caregivers, and child care staff at fall enrollment, midline, and spring, following intervention completion. Analyses include linear mixed-models, accounting for clustering and repeated measures, incorporating center-arms as moderators. CHAMP will provide evidence-based information to inform wellness guidelines and policies that can be disseminated broadly, to ensure that child care centers provide opportunities for children to develop healthy eating, and physical activity habits. Trial Registration: NCT03111264; https://clinicaltrials.gov/ct2/show/NCT03111264.
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Determinants of successful lifestyle change during a 6-month preconception lifestyle intervention in women with obesity and infertility.
Karsten, MDA, van Oers, AM, Groen, H, Mutsaerts, MAQ, van Poppel, MNM, Geelen, A, van de Beek, C, Painter, RC, Mol, BWJ, Roseboom, TJ, et al
European journal of nutrition. 2019;(6):2463-2475
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PURPOSE To identify demographic, (bio)physical, behavioral, and psychological determinants of successful lifestyle change and program completion by performing a secondary analysis of the intervention arm of a randomized-controlled trial, investigating a preconception lifestyle intervention. METHODS The 6-month lifestyle intervention consisted of dietary counseling, physical activity, and behavioral modification, and was aimed at 5-10% weight loss. We operationalized successful lifestyle change as successful weight loss (≥ 5% weight/BMI ≤ 29 kg/m2), weight loss in kilograms, a reduction in energy intake, and an increase in physical activity during the intervention program. We performed logistic and mixed-effect regression analyses to identify baseline factors that were associated with successful change or program completion. RESULTS Women with higher external eating behavior scores had higher odds of successful weight loss (OR 1.10, 95% CI 1.05-1.16). Women with the previous dietetic support lost 0.94 kg less during the intervention period (95% CI 0.01-1.87 kg). Women with higher self-efficacy reduced energy intake more than women with lower self-efficacy (p < 0.01). Women with an older partner had an increased energy intake (6 kcal/year older, 95% CI 3-13). A high stage of change towards physical activity was associated with a higher number of daily steps (p = 0.03). A high stage of change towards weight loss was associated with completion of the intervention (p = 0.04). CONCLUSIONS Determinants of lifestyle change and program completion were: higher external eating behavior, not having received previous dietetic support, high stage of change. This knowledge can be used to identify women likely to benefit from lifestyle interventions and develop new interventions for women requiring alternative support. TRIAL REGISTRATION The LIFEstyle study was registered at the Dutch trial registry (NTR 1530; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1530 ).
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Implementing School-Based Policies to Prevent Obesity: Cluster Randomized Trial.
Ickovics, JR, Duffany, KO, Shebl, FM, Peters, SM, Read, MA, Gilstad-Hayden, KR, Schwartz, MB
American journal of preventive medicine. 2019;(1):e1-e11
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INTRODUCTION Healthier school environments can benefit students, and school wellness policies may result in meaningful enhancements. Schools participating in federal child nutrition programs must implement wellness policies as mandated by law. The primary study objective is to assess effectiveness of implementing school-based nutrition and physical activity policies on student BMI trajectories. STUDY DESIGN Cluster randomized trial using 2 × 2 factorial design. SETTING/PARTICIPANTS Twelve randomly selected schools in an urban district. Students were followed for 3 years through middle school, fifth to eighth grades (2011-2015, n=595 students, 92.3% participation, 85.2% retention). INTERVENTION Specific to randomized condition, support was provided for implementation of nutrition policies (e.g., alternatives to food-based rewards/celebrations) and physical activity policies (e.g., opportunities for physical activity during/after school). MAIN OUTCOME MEASURES Sex-/age-adjusted BMI percentile and BMI z-score; behavioral indicators. Data collected via standardized protocols. RESULTS Analyses followed intention-to-treat principles, with planned secondary analyses (conducted 2016-2018). Students at schools randomized to receive support for nutrition policy implementation had healthier BMI trajectories over time (F=3.20, p=0.02), with a greater magnitude over time and cumulatively significant effects 3 years post-intervention (β=-2.40, p=0.04). Overall, students at schools randomized to receive the nutrition intervention had an increase in BMI percentile of <1%, compared with students in other conditions, whereas BMI percentile increased 3%-4%. There was no difference in student BMI between those in schools with and without physical activity policy implementation. Examining behavioral correlates in eighth grade, students at schools randomized to the nutrition condition consumed fewer unhealthy foods and sugar-sweetened beverages, and ate less frequently at fast-food restaurants (all p<0.03). CONCLUSIONS This cluster randomized trial demonstrated effectiveness of providing support for implementation of school-based nutrition policies, but not physical activity policies, to limit BMI increases among middle school students. Results can guide future school interventions. TRIAL REGISTRATION This study is registered at www.clinicaltrials.gov NCT02043626.