-
1.
A pragmatic controlled trial to prevent childhood obesity within a risk group at maternity and child health-care clinics: results up to six years of age (the VACOPP study).
Mustila, T, Raitanen, J, Keskinen, P, Luoto, R
BMC pediatrics. 2018;(1):89
Abstract
BACKGROUND Obesity in childhood appears often during the toddler years. The prenatal environment influences obesity risk. Maternal gestational diabetes, the child's diet, and physical activity in the first few years have an important role in subsequent weight gain. A study was conducted to evaluate effectiveness of a primary health-care lifestyle counselling intervention in prevention of childhood obesity up to 6 years of age. METHODS The study was a controlled pragmatic trial to prevent childhood obesity and was implemented at maternity and child health-care clinics. The participants (n = 185) were mothers at risk of gestational diabetes mellitus with their offspring born between 2008 and 2010. The prenatal intervention, started at the end of the first trimester of pregnancy, consisted of counselling on diet and physical activity by municipal health-care staff. The intervention continued at yearly appointments with a public health-nurse at child health-care clinics. The paper reports the offspring weight gain results for 2-6 years of age. Weight gain up to 6 years of age was assessed as BMI standard deviation scores (SDS) via a mixed-effect linear regression model. The proportion of children at 6 years with overweight/obesity was assessed as weight-for-height percentage and ISO-BMI. Priority was not given to power calculations, because of the study's pragmatic nature. RESULTS One hundred forty seven children's (control n = 76/85% and intervention n = 71/56%) weight and height scores were available for analysis at 6 years of age. There was no significant difference in weight gain or overweight/obesity proportions between the groups at 6 years of age, but the proportion of children with obesity in both groups was high (assessed as ISO-BMI 9.9% and 11.8%) relative to prevalence in this age group in Finland. CONCLUSION As the authors previously reported, the intervention-group mothers had lower prevalence of gestational diabetes mellitus, but a decrease in obesity incidence before school age among their offspring was not found. The authors believe that an effective intervention should start before conception, continuing during pregnancy and the postpartum period through the developmentally unique child's first years. TRIAL REGISTRATION ClinicalTrials.gov NCT00970710 . Registered 1 September 2009. Retrospectively registered.
-
2.
Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation.
Lloyd, J, Dean, S, Creanor, S, Abraham, C, Hillsdon, M, Ryan, E, Wyatt, KM
The international journal of behavioral nutrition and physical activity. 2017;(1):163
Abstract
BACKGROUND The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. METHODS Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. RESULTS All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. CONCLUSION Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. TRIAL REGISTRATION ISRCTN15811706.
-
3.
How effective is community physical activity promotion in areas of deprivation for inactive adults with cardiovascular disease risk and/or mental health concerns? Study protocol for a pragmatic observational evaluation of the 'Active Herts' physical activity programme.
Howlett, N, Jones, A, Bain, L, Chater, A
BMJ open. 2017;(11):e017783
Abstract
INTRODUCTION There is a high prevalence of inactive adults in the UK, and many suffer from conditions such as cardiovascular disease (CVD) or poor mental health. These coexist more frequently in areas of higher socioeconomic deprivation. There is a need to test the effectiveness, acceptability and sustainability of physical activity programmes. Active Herts uses novel evidence-based behaviour change techniques to target physical inactivity. METHODS AND ANALYSIS Active Herts is a community physical activity programme for inactive adults aged 16+ with one or more risk factors for CVD and/or a mild to moderate mental health condition. This evaluation will follow a mixed-methods longitudinal (baseline, and 3-month, 6-month and 12-month follow-ups) design. Pragmatic considerations mean delivery of the programme differs by locality. In two areas programme users will receive a behaviour change technique booklet, regular consultations, a booster phone call, motivational text messages and signposting to 12 weeks of exercise classes. In another two areas programme users will also receive 12 weeks of free tailored exercise classes, with optional exercise 'buddies' available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, well-being, psychological capability and reflective motivation as secondary outcomes. A process evaluation will explore the views of stakeholders, delivery staff and programme leads. Economic evaluation will examine the programme costs against the benefits gained in terms of reduced risk of morbidity. ETHICS AND DISSEMINATION This study was been approved by the Faculty of Medicine and Health Sciences Research Ethics Committee at the University of East Anglia. Informed written consent will be obtained from programme users in the evaluation. Results will be published in peer-reviewed journals, presented at conferences, and shared through the study website and local community outlets. TRIAL REGISTRATION NUMBER ClinicalTrials.gov ID number: NCT03153098.
-
4.
The HAT TRICK programme for improving physical activity, healthy eating and connectedness among overweight, inactive men: study protocol of a pragmatic feasibility trial.
Caperchione, CM, Bottorff, JL, Oliffe, JL, Johnson, ST, Hunt, K, Sharp, P, Fitzpatrick, KM, Price, R, Goldenberg, SL
BMJ open. 2017;(9):e016940
Abstract
INTRODUCTION Physical activity, healthy eating and maintaining a healthy weight are associated with reduced risk of cardiovascular disease, type 2 diabetes and cancer and with improved mental health. Despite these benefits, many men do not meet recommended physical activity guidelines and have poor eating behaviours. Many health promotion programmes hold little appeal to men and consequently fail to influence men's health practices. HAT TRICK was designed as a 12-week face-to-face, gender-sensitised intervention for overweight and inactive men focusing on physical activity, healthy eating and social connectedness and was delivered in collaboration with a major junior Canadian ice hockey team (age range 16-20 years). The programme was implemented and evaluated to assess its feasibility. This article describes the intervention design and study protocol of HAT TRICK. METHODS AND ANALYSIS HAT TRICK participants (n=60) were men age 35 years, residing in the Okanagan Region of British Columbia, who accumulate 150 min of moderate to vigorous physical activity a week, with a body mass index of >25 kg/m2 and a pant waist size of >38'. Each 90 min weekly session included targeted health education and theory-guided behavioural change techniques, as well as a progressive (ie, an increase in duration and intensity) group physical activity component. Outcome measures were collected at baseline, 12 weeks and 9 months and included the following: objectively measured anthropometrics, blood pressure, heart rate, physical activity and sedentary behaviour, as well as self-reported physical activity, sedentary behaviour, diet, smoking, alcohol consumption, sleep habits, risk of depression, health-related quality of life and social connectedness. Programme feasibility data (eg, recruitment, satisfaction, adherence, content delivery) were assessed at 12 weeks via interviews and self-report. ETHICS AND DISSEMINATION Ethical approval was obtained from the University of British Columbia Okanagan Behavioural Research Ethics Board (reference no H1600736). Study findings will be disseminated through academic meetings, peer-reviewed publication, web-based podcasts, social media, plain language summaries and co-delivered community presentations. TRIAL REGISTRATION NUMBER ISRCTN43361357,Pre results.
-
5.
Pragmatic cluster randomised trial of a free telephone-based health coaching program to support women in managing weight gain during pregnancy: the Get Healthy in Pregnancy Trial.
Clements, V, Leung, K, Khanal, S, Raymond, J, Maxwell, M, Rissel, C
BMC health services research. 2016;(1):454
Abstract
BACKGROUND Excessive gestational weight gain can result in poor maternal and child health outcomes. Estimates from single studies indicate the prevalence of excessive gestational weight gain in Australia could lie between 38 and 67 %. The risk of excessive weight gain can be reduced through healthy eating and exercise. We describe the rationale and methods of the Get Healthy in Pregnancy Service, a trial service which aims to support women in achieving appropriate gestational weight gain through an existing telephone-based health coaching service. METHODS/DESIGN This study aims to compare the effectiveness of a telephone-based health coaching program versus provision of information only in supporting pregnant women to achieve appropriate gestational weight gain. A pragmatic stratified clustered randomised controlled trial will be conducted with 710 women who present to 5 hospitals for their first antenatal appointment during the recruitment period (6-8 months), have a pre-pregnancy body mass index (BMI) ≥ 18.50 (healthy weight or above), are 18 years and over, singleton gestation, English speaking, have no pre-existing medical conditions that may limit their ability to exercise or require a restricted diet and are 18 weeks or less gestation. Hospitals will be randomised into one of two intervention models: a) information only; or b) information plus 10 telephone-based health coaching sessions with a university qualified coach. Both interventions will set a weight-range target with pregnant women. The women attending antenatal clinics at participating hospitals will be screened at their initial hospital appointment to assess their eligibility. Women recruited to the trial will have a number of measures recorded including anthropometrics (self-reported height and weight) and dietary and physical activity scores during and following pregnancy. These measurements will be collected at baseline (prior to 18 weeks gestation), 36 weeks gestation and 12 months post-birth. DISCUSSION This study responds to a need for an effective intervention that targets excessive gestational weight gain at a population level. This study investigates the potential for an innovative intervention combining two existing services; a free state-wide telephone-based health coaching service and hospital-based antenatal care to support pregnant women to achieve healthy weight gain during pregnancy. The use of existing services provides the potential for immediate post-study implementation. While the impacts of telephone-based lifestyle programmes have been tested in a number of settings, there are few studies which evaluate the effectiveness and acceptability of telephone support in achieving healthy gestational weight gain in association with routine antenatal care. TRIAL REGISTRATION ACTRN12615000397516 (Registration date: 26 June 2014, retrospectively registered).
-
6.
Pragmatic, Randomized Controlled Trials of the Girls on the Go! Program to Improve Self-Esteem in Girls.
Tirlea, L, Truby, H, Haines, TP
American journal of health promotion : AJHP. 2016;(4):231-41
Abstract
PURPOSE To test the effectiveness of an intervention delivered by health professionals outside the school environment to girls identified with issues such as poor body image, low self-esteem, low self-confidence, nonparticipation in sports, or being overweight or underweight. DESIGN The study's design was a stepped-wedge randomized controlled trial to test the efficacy of an intervention on self-esteem, impairment induced by eating disorders, self-efficacy, body satisfaction, and dieting behaviors. SETTING The study took place at the community health center located in a culturally diverse area of Melbourne, Victoria, Australia. SUBJECTS Participants were 122 primary and secondary school girls between 10 and 16 years of age. INTERVENTION Girls on the Go! is a 10-week program designed to improve self-esteem, body image, and confidence, using an empowerment model that involved interactive and experiential learning approaches. Weekly themes included body image and self-esteem, safety and assertiveness, a healthy mind, physical activity, healthy eating, trust and confidence, and connections. MEASURES Measurements were made using Rosenberg Self-Esteem Scale, clinical interview assessment, health self-efficacy (included mental health and physical health self-efficacy scales), body esteem scale, and the Dutch Eating Behavior Questionnaire for Children. ANALYSIS A linear mixed model was used. RESULTS The intervention led to a significant increase (p < .05) in self-esteem and self-efficacy (mental and physical health self-efficacy subscales), for both primary and secondary school-aged participants and reduced dieting behaviors (secondary school participants). These gains were retained after 6 months of follow-up. CONCLUSION This group-based, low-dose intervention, which, although targeting girls with a range of psychological issues and including both overweight and underweight participants, is a successful means of improving self-esteem among girls from diverse cultural backgrounds.
-
7.
Pragmatic replication trial of health promotion coaching for obesity in serious mental illness and maintenance of outcomes.
Bartels, SJ, Pratt, SI, Aschbrenner, KA, Barre, LK, Naslund, JA, Wolfe, R, Xie, H, McHugo, GJ, Jimenez, DE, Jue, K, et al
The American journal of psychiatry. 2015;(4):344-52
-
-
Free full text
-
Abstract
OBJECTIVE Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and none have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The authors sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population. METHOD Persons with serious mental illness and a body mass index (BMI) >25 receiving services in three community mental health organizations were recruited and randomly assigned either to the 12-month In SHAPE program, which included membership in a public fitness club and weekly meetings with a health promotion coach, or to fitness club membership alone. The primary outcome measures were weight and cardiorespiratory fitness (as measured with the 6-minute walk test), assessed at baseline and at 3, 6, 9, 12, and 18 months. RESULTS Participants (N=210) were ethnically diverse (46% were nonwhite), with a mean baseline BMI of 36.8 (SD=8.2). At 12 months, the In SHAPE group (N=104) had greater reduction in weight and improved fitness compared with the fitness club membership only group (N=106). Primary outcomes were maintained at 18 months. Approximately half of the In SHAPE group (51% at 12 months and 46% at 18 months) achieved clinically significant cardiovascular risk reduction (a weight loss ≥5% or an increase of >50 meters on the 6-minute walk test). CONCLUSIONS This is the first replication study confirming the effectiveness of a health coaching intervention in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese persons with serious mental illness.
-
8.
The wellness incentives and navigation project: design and methods.
Shenkman, E, Muller, K, Vogel, B, Nixon, SJ, Wagenaar, AC, Case, K, Guo, Y, Wegman, M, Aric, J, Stoner, D
BMC health services research. 2015;:579
Abstract
BACKGROUND About 35 % of non-elderly U.S. adult Medicaid enrollees have a behavioral health condition, such as anxiety, mood disorders, substance use disorders, and/or serious mental illness. Individuals with serious mental illness, in particular, have mortality rates that are 2 to 3 times higher as the general population, which are due to multiple factors including inactivity, poor nutrition, and tobacco use. 61 % of Medicaid beneficiaries with behavioral health conditions also have multiple other co-occurring chronic physical health conditions, which further contributes to morbidity and mortality. The Wellness Incentives and Navigation (WIN) project is one of 10 projects under the Centers for Medicare and Medicaid Services "Medicaid Incentives for the Prevention of Chronic Diseases" Initiative, to "test the effectiveness of providing incentives directly to Medicaid beneficiaries of all ages who participate in prevention programs, and change their health risks and outcomes by adopting healthy behaviors." METHODS/DESIGN WIN is a three-year randomized pragmatic clinical trial designed to examine the comparative effectiveness of the combined use of personal navigators, motivational interviewing, and a flexible wellness account on cardiovascular risk reduction among individuals in Medicaid with co-occurring physical and mental health conditions or serious mental illness alone relative to the usual care provided within Medicaid Managed Care. 1250 individuals, identified through Medicaid claims data, were recruited and randomly assigned to an intervention group or control group with outcomes tracked annually. A comparison group was also recruited to help assess the study's internal validity. DISCUSSION The primary outcomes are physical and mental health related quality-of-life as measured by the SF-12, and BMI, blood pressure, LDL-C, and Hba1c results for those who are diabetic measured clinically. The purpose of this paper is to present the unique design of the WIN trial prior to results becoming available in hopes of assisting other researchers in conducting community-based randomized pragmatic trials. Outcomes will be assessed through the linkage of patient reported outcomes, health care claims, and electronic health record data. TRIAL REGISTRATION NCT02440906.
-
9.
A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial.
Hunt, K, Wyke, S, Gray, CM, Anderson, AS, Brady, A, Bunn, C, Donnan, PT, Fenwick, E, Grieve, E, Leishman, J, et al
Lancet (London, England). 2014;(9924):1211-21
Abstract
BACKGROUND The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. METHODS We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35-65 years with a body-mass index (BMI) of 28 kg/m(2) or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2-9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. FINDINGS 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95-5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64-5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to participation in the programme (gallbladder removal and ruptured Achilles tendon). INTERPRETATION The FFIT programme can help a large proportion of men to lose a clinically important amount of weight; it offers one effective strategy to challenge male obesity. FUNDING Scottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06).