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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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Influencing cardiovascular health habits in the rural, deep south: results of a cluster randomized trial.
Abbott, LS, Slate, EH, Lemacks, JL
Health education research. 2019;(2):200-208
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Abstract
Cardiovascular disease (CVD) is a major cause of death among people living in the United States. Populations, especially minorities, living in the rural South are disproportionately affected by CVD and have greater CVD risk, morbidity and mortality. Culturally relevant cardiovascular health programs implemented in rural community settings can potentially reduce CVD risk and facilitate health behavior modification. The purpose of this study was to examine the effects of a cardiovascular health promotion intervention on the health habits of a group of rural African American adults. The study had a cluster randomized controlled trial design involving 12 rural churches that served as statistical clusters. From the churches (n = 6) randomized to the intervention group, 115 participants were enrolled, received the 6-week health program and completed pretest-posttest measures. The 114 participants from the control group churches (n = 6) did not receive the health program and completed the same pretest-posttest measures. The linear mixed model was used to compare group differences from pretest to posttest. The educational health intervention positively influenced select dietary and confidence factors that may contribute toward CVD risk reduction.
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A physical activity, nutrition and oral health intervention in nursery settings: process evaluation of the NAP SACC UK feasibility cluster RCT.
Langford, R, Jago, R, White, J, Moore, L, Papadaki, A, Hollingworth, W, Metcalfe, C, Ward, D, Campbell, R, Wells, S, et al
BMC public health. 2019;(1):865
Abstract
BACKGROUND The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA. A feasibility randomised controlled trial was conducted in England to adapt the intervention to the UK context. An embedded process evaluation focused on three key questions. 1. Was it feasible and acceptable to implement the intervention as planned? 2. How did the intervention affect staff and parent mediators? 3. Were the trial design and methods acceptable? METHODS Twelve nurseries in south-west England were recruited and randomised to intervention or control. The intervention comprised: NAP SACC UK Partner (Health Visitor) support to nurseries to review practice and policies against best practice, and then set goals to improve physical activity, nutrition and oral health; two staff training workshops; and a web-based parent support element. The process evaluation comprised: observations of Partner training (n = 1), Partner/manager meetings (n = 5) and staff workshops (n = 10); semi-structured interviews with Partners (n = 4), managers (n = 12), staff (n = 4) and parents (n = 20); analysis of self-assessment forms, goal setting forms and Partner logbooks; and assessment of staff and parent knowledge, motivation and self-efficacy mediators. RESULTS Overall, NAP SACC UK was feasible to implement and acceptable to nursery staff, managers, Partners and parents. The intervention was implemented as planned in five of the six intervention nurseries. Partners and managers appreciated the opportunity to review and improve nursery practices and valued the relationship forged between them. Staff rated the training workshops highly, despite attending outside of working hours. Most goals set by nurseries were achieved. However, Partners raised concerns about Health Visitors' capacity to deliver the intervention in any subsequent roll out. Mediator scores improved in all but two areas in intervention staff and parents, with decreases or minimal changes in the control group. The web-based parent element was not well used and should be removed from any subsequent trial. The trial methods were acceptable to managers, staff, Partners and parents. CONCLUSIONS Implementing and evaluating a physical activity and nutrition intervention in nursery settings is feasible and acceptable. A full RCT of NAP SACC UK (with appropriate modifications) is warranted. TRIAL REGISTRATION ISRCTN16287377 (10 Apr 2015).
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Eating-Related and Psychological Outcomes of Health at Every Size Intervention in Health and Social Services Centers Across the Province of Québec.
Bégin, C, Carbonneau, E, Gagnon-Girouard, MP, Mongeau, L, Paquette, MC, Turcotte, M, Provencher, V
American journal of health promotion : AJHP. 2019;(2):248-258
Abstract
PURPOSE To report the outcomes of a Health at Every Size (HAES) intervention in a real-world setting. DESIGN Quasi-experimental design evaluating eating behaviors and psychological factors. SETTING The HAES intervention is offered in Health and Social Services Centers in Québec (Canada). PARTICIPANTS For this study, 216 women (body mass index [BMI]: 35.76 [6.80] kg/m2) who participated to the HAES intervention were compared to 110 women (BMI: 34.56 [7.30] kg/m2) from a comparison group. INTERVENTION The HAES intervention is composed of 14 weekly meetings provided by health professionals. It focuses on healthy lifestyle, self-acceptance, and intuitive eating. MEASURES Eating behaviors (ie, flexible restraint, rigid restraint, disinhibition, susceptibility to hunger, intuitive eating, and obsessive-compulsive eating) and psychological correlates (ie, body esteem, self-esteem, and depression) were assessed using validated questionnaires at baseline, postintervention, and 1-year follow-up. ANALYSIS Group, time, and interaction effects analyzed with mixed models. RESULTS Significant group by time interactions were found for flexible restraint ( P = .0400), disinhibition ( P < .0001), susceptibility to hunger ( P < .0001), intuitive eating ( P < .0001), obsessive-compulsive eating ( P < .0001), body-esteem ( P < .0001), depression ( P = .0057), and self-esteem ( P < .0001), where women in the HAES group showed greater improvements than women in the comparison group at short and/or long term. CONCLUSION The evaluation of this HAES intervention in a real-life context showed its effectiveness in improving eating-, weight-, and psychological-related variables among women struggling with weight and body image.
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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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Dose-Response Relationship in a Healthy Habits Study for Head Start Preschoolers.
Ling, J, Zahry, NR, Robbins, LB
Nursing research. 2019;(4):329-335
Abstract
BACKGROUND Understanding the dose-response relationship in behavioral interventions is critical to guide future research efforts. However, only few studies have fully examined the dose-response relationship especially among children. OBJECTIVE The aim of the study was to examine the relationships between level of participation and intervention effects. METHODS The study used data from 39 Head Start parent-preschooler dyads participating in a 10-week lifestyle intervention. The intervention included daily center-based preschooler program, preschooler weekly letters to parents, parent meetings, and weekly Facebook-based program. Height, weight, waist circumference (WC), moderate-to-vigorous physical activity (MVPA), screen time, and fruit/vegetable intake were assessed. RESULTS Preschooler program average daily attendance was 79%, and Facebook-based program average completion rate was 80%. About 49% attended all three parent meetings. Parent meeting attendance was significantly and positively related to preschoolers' vegetable intake (p = .023) and MVPA (p < .001) and parents' MVPA (p = .016). Preschooler letters were significantly and negatively related to preschoolers' screen time (p = .002) and parents' WC (p = .027) and positively correlated with parents' MVPA (p = .01). Preschooler program attendance was not significantly correlated with their body mass index (ρ = -.31) or WC (ρ = -.16). DISCUSSION The study provides important information for designing effective interventions among low-income families. The findings imply that (a) parent-only interventions and parent-child interventions may result in similar effects, (b) future behavioral interventions should focus on the bidirectional parent-child relationship, and (c) it is important to include face-to-face contacts in lifestyle interventions. In addition, it highlights the need to examine the dose-response relationship in multicomponent lifestyle interventions.
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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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Efficacy of Nutrition and WASH/Malaria Educational Community-Based Interventions in Reducing Anemia in Preschool Children from Bengo, Angola: Study Protocol of a Randomized Controlled Trial.
Fançony, C, Soares, Â, Lavinha, J, Barros, H, Brito, M
International journal of environmental research and public health. 2019;(3)
Abstract
Angola reports one of the highest infant mortality rates in the world, and anemia represents one of its important causes. Recent studies, in under-five children from the Bengo province of Angola, described high prevalence's, suggesting malaria, undernutrition and urogenital schistosomiasis as important contributors for the occurrence and spatial variations of anemia. Educational community-based interventions, either in Nutrition and Water, Sanitation, Hygiene and Malaria are recommended to correct anemia. Herein, we designed a cluster-randomized controlled trial to study the efficacy of two educational-plus-therapeutic interventions in the reduction of anemia: one in nutrition and the other in WASH/Malaria. Socioeconomic, nutritional, anthropometric, parasitological and biochemical data will be collected from all willing-to-participate children, aging under four and resident in the Health Research Center of Angola study area. Considering the multifactorial causes of this condition, determining the efficacy of both interventions might help documenting weaknesses and opportunities for planning integrated strategies to reduce anemia.
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'We're all in the same boat': A qualitative study on how groups work in a diabetes prevention and management programme.
Borek, AJ, Abraham, C, Greaves, CJ, Tarrant, M, Garner, N, Pascale, M
British journal of health psychology. 2019;(4):787-805
Abstract
OBJECTIVES Although many health interventions are delivered in groups, it is unclear how group context can be best used to promote health-related behaviour change and what change processes are most helpful to participants. This study explored participants' experiences of attending type 2 diabetes prevention and management programme, and their perceptions of how group participation influenced changes in diet and physical activity. DESIGN Qualitative. METHODS Semi-structured telephone interviews were conducted with 20 participants (twelve men) from nine groups in the Norfolk Diabetes Prevention Study. Interviews were audio-recorded, transcribed verbatim, and analysed using thematic analysis in NVivo. RESULTS Participants benefited from individual change processes, including information provision, structuring and prioritizing health goals, action planning, self-monitoring, and receiving feedback. They also benefited from group processes, including having a common purpose, sharing experiences, making social comparisons, monitoring and accountability, and providing and receiving social support in the groups. Participants' engagement with, and benefits from, the groups were enhanced when there was a supportive group context (i.e., group cohesion, homogeneous group composition, and a positive group atmosphere). Optimal facilitation to develop an appropriate group context and initiate effective change processes necessitated good facilitator interpersonal and professional skills, credibility and empathy, and effective group facilitation methods. Participants reported developing a sense of responsibility and making behaviour changes that resulted in improvements in health outcomes and weight loss. CONCLUSIONS This study highlights the role of individual and group processes in facilitating health-promoting behaviour change, and the importance of group context and optimal facilitation in promoting engagement with the programme. Statement of contribution What is already known on this subject? Many health interventions, including programmes to help prevent or manage diabetes and facilitate weight loss, are delivered in groups. Such group-based behaviour-change interventions are often effective in facilitating psychological and behaviour change. There is considerable research and theory on individual change processes and techniques, but less is known about which change processes and techniques facilitate behaviour change in group settings. What does this study add? This study contributes to our understanding of how participating in group-based health programmes may enhance or impede individual behaviour change. It identified individual (intrapersonal) and group (interpersonal, facilitated through group interaction) change processes that were valued by group participants. The findings also show how these change processes may be affected by the group context. A diagram summarizes the identified themes helping to understand interactions between these key processes occurring in groups. The study offers an insight into participants' views on, and experiences of, attending a group-based diabetes prevention and management programme. Thus, it helps better understand how the intervention might have helped them (or not) and what processes may have influenced intervention outcomes. Key practical recommendations for designing and delivering group-based behaviour-change interventions are presented, which may be used to improve future group-based health interventions.
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The effect of a programme to improve men's sedentary time and physical activity: The European Fans in Training (EuroFIT) randomised controlled trial.
Wyke, S, Bunn, C, Andersen, E, Silva, MN, van Nassau, F, McSkimming, P, Kolovos, S, Gill, JMR, Gray, CM, Hunt, K, et al
PLoS medicine. 2019;(2):e1002736
Abstract
BACKGROUND Reducing sitting time as well as increasing physical activity in inactive people is beneficial for their health. This paper investigates the effectiveness of the European Fans in Training (EuroFIT) programme to improve physical activity and sedentary time in male football fans, delivered through the professional football setting. METHODS AND FINDINGS A total of 1,113 men aged 30-65 with self-reported body mass index (BMI) ≥27 kg/m2 took part in a randomised controlled trial in 15 professional football clubs in England, the Netherlands, Norway, and Portugal. Recruitment was between September 19, 2015, and February 2, 2016. Participants consented to study procedures and provided usable activity monitor baseline data. They were randomised, stratified by club, to either the EuroFIT intervention or a 12-month waiting list comparison group. Follow-up measurement was post-programme and 12 months after baseline. EuroFIT is a 12-week, group-based programme delivered by coaches in football club stadia in 12 weekly 90-minute sessions. Weekly sessions aimed to improve physical activity, sedentary time, and diet and maintain changes long term. A pocket-worn device (SitFIT) allowed self-monitoring of sedentary time and daily steps, and a game-based app (MatchFIT) encouraged between-session social support. Primary outcome (objectively measured sedentary time and physical activity) measurements were obtained for 83% and 85% of intervention and comparison participants. Intention-to-treat analyses showed a baseline-adjusted mean difference in sedentary time at 12 months of -1.6 minutes/day (97.5% confidence interval [CI], -14.3-11.0; p = 0.77) and in step counts of 678 steps/day (97.5% CI, 309-1.048; p < 0.001) in favor of the intervention. There were significant improvements in diet, weight, well-being, self-esteem, vitality, and biomarkers of cardiometabolic health in favor of the intervention group, but not in quality of life. There was a 0.95 probability of EuroFIT being cost-effective compared with the comparison group if society is willing to pay £1.50 per extra step/day, a maximum probability of 0.61 if society is willing to pay £1,800 per minute less sedentary time/day, and 0.13 probability if society is willing to pay £30,000 per quality-adjusted life-year (QALY). It was not possible to blind participants to group allocation. Men attracted to the programme already had quite high levels of physical activity at baseline (8,372 steps/day), which may have limited room for improvement. Although participants came from across the socioeconomic spectrum, a majority were well educated and in paid work. There was an increase in recent injuries and in upper and lower joint pain scores post-programme. In addition, although the five-level EuroQoL questionnaire (EQ-5D-5L) is now the preferred measure for cost-effectiveness analyses across Europe, baseline scores were high (0.93), suggesting a ceiling effect for QALYs. CONCLUSION Participation in EuroFIT led to improvements in physical activity, diet, body weight, and biomarkers of cardiometabolic health, but not in sedentary time at 12 months. Within-trial analysis suggests it is not cost-effective in the short term for QALYs due to a ceiling effect in quality of life. Nevertheless, decision-makers may consider the incremental cost for increase in steps worth the investment. TRIAL REGISTRATION International Standard Randomised Controlled Trials, ISRCTN-81935608.