Samantha Kozica

Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial

BackgroundTo impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities.MethodsHere we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program.DiscussionImplementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally.Trial registrationANZ clinical trial registry ACTRN12612000115831. Date of registration 24/01/2012

Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial

Background Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information. Methods and Findings We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters) randomised using a computer-generated randomisation list for intervention (n = 21) or control (n = 20). Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her) consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women’s health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/− SD 6.7) and BMI of 28.8 kg/m2 (+/− SD 6.9) with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI −0.09 to 0.97) and in the intervention group −0.48kg (95% CI −0.99 to 0.03) with an unadjusted between group difference of −0.92 kg (95% CI −1.67 to −0.16) or −0.87 kg (95% CI −1.62 to −0.13) adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures. Conclusions A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included community integration, nonprescriptive simple health messages, small changes to behaviour, low participant burden, self-weighing, and delivery including a mix of group, phone, and SMS text reminders. The findings support population strategies to halt the rise in obesity prevalence.

Initiating and Continuing Behaviour Change within a Weight Gain Prevention Trial: A Qualitative Investigation

Background Preventing obesity is an international health priority. In Australia, young women who live in rural communities are at high risk of unhealthy weight gain. Interventions which engage young women and support sustainable behaviour change are needed and comprehensive evaluation of such interventions generates knowledge for population scale-up. This qualitative sub-study aims to identify enablers and barriers to behaviour change initiation and continuation within a community weight gain prevention program. Methods In-depth semi-structured interviews were conducted with program participants 6 months after baseline. All interviews were audio-taped and transcribed verbatim. Transcripts were analysed independently by two investigators via thematic analysis. Participants A total of 28 women with a mean age of 39.9±6.2years and a BMI of 28.6±5.2kg/m2 were purposively recruited from the larger cohort (n = 649) that participated in the prevention trial. Results Four behaviour change groups emerged were identified from participant interviews: (i) no change, (ii) relapse, (iii) intermittent and (iv) continued change. Factors influencing behaviour change initiation and continuation included realistic program expectations and the participant’s ability to apply the core program elements including: setting small, achievable behaviour change goals, problem solving and using self-management techniques. Personal knowledge, skills, motivation, self-efficacy, accountability and perceived social and environmental barriers also affected behaviour change. Satisfaction with personal program progress and the perceived amount of program supports required to achieve ongoing behaviour change varied amongst participants. Women who relapsed expressed a desire for more intensive and regular support from health professionals, identified more barriers unrelated to the program, anticipated significant weight loss and had lower satisfaction with their progress. Conclusion Initiating and continuing behaviour change is a complex process. Our findings elucidate that initiation and continuation of behaviour change in women undertaking a weight gain prevention program may be facilitated by accurate and realistic understanding of program expectation, the ability to apply the core program messages, higher internal motivation, self-efficacy and minimal social and environmental barriers. Trial Registration Australia & New Zealand Clinical Trial Registry ACTRN12612000115831 www.anzctr.org.au

Acceptability of delivery modes for lifestyle advice in a large scale randomised controlled obesity prevention trial

BackgroundPreventing obesity is an international health priority and women living in rural communities are at an increased risk of weight gain. Lifestyle programs are needed as part of a comprehensive approach to prevent obesity. Evaluation provides a unique opportunity to investigate and inform improvements in lifestyle program implementation strategies. The Healthy Lifestyle Program for rural women (HeLP-her Rural) is a large scale, cluster randomized control trial, targeting the prevention of weight gain. This program utilises multiple delivery modes for simple lifestyle advice (group sessions, phone coaching, text messages, and an interactive program manual). Here, we describe the acceptability of these various delivery modes.MethodsA mixed-method process evaluation was undertaken measuring program fidelity, recruitment strategies, dose delivered, program acceptability and contextual factors influencing program implementation. Data collection methodologies included qualitative semi-structured interviews for a sub-group of intervention participants [n = 28] via thematic analysis and quantitative methods (program checklists and questionnaires [n = 190]) analysed via chi square and t-tests.ResultsWe recruited 649 women from 41 rural townships into the HeLP-her Rural program with high levels of program fidelity, dose delivered and acceptability. Participants were from low socioeconomic townships and no differences were detected between socioeconomic characteristics and the number of participants recruited across the towns (p = 0.15). A face-to-face group session was the most commonly reported preferred delivery mode for receiving lifestyle advice, followed by text messages and phone coaching. Multiple sub-themes emerged to support the value of group sessions which included: promoting of a sense of belonging, mutual support and a forum to share ideas. The value of various delivery modes was influenced by participant’s various needs and learning styles.ConclusionThis comprehensive evaluation reveals strong implementation fidelity and high levels of dose delivery. We demonstrate reach to women from relatively low income rural townships and highlight the acceptability of low intensity healthy lifestyle programs with mixed face-to-face and remote delivery modes in this population. Group education sessions were the most highly valued component of the intervention, with at least one face-to-face session critical to successful program implementation. However, lifestyle advice via multiple delivery modes is recommended to optimise program acceptability and ultimately effectiveness.Trial registryAustralia & New Zealand Clinical Trial Registry. Trial number ACTRN12612000115831, date of registration24/01/2012.

Assessing self-efficacy and self-help methods in women with and without Polycystic Ovary Syndrome.

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder in women strongly associated with obesity and psychological dysfunction. It is crucial to assess the contributions of psychological parameters to obesity and weight management. This survey based cross-sectional study assessed self-efficacy, health attitudes and beliefs, response to illness and adult health history in women with (n = 74) and without PCOS (n = 90). There were no significant differences in self-efficacy, health attitudes and beliefs between groups. Women with PCOS reported less engagement in self-help methods compared to women without (p = 0.003). Women with PCOS reported poorer overall (p < 0.001) and recent health history (p = 0.02), greater prevalence (p < 0.001) and impact of a chronic illness (p < 0.001). It is crucial that women recognize that PCOS is a chronic condition requiring on-going lifestyle management; to encourage active engagement in their management, enhance participation in screening for complications and uptake of lifestyle recommendations.

Health-related behaviors in women with lifestyle-related diseases.

Lifestyle related diseases associated with physical inactivity and poor diet quality, represent a major health burden. This study assessed negative and positive health habits and health care utilization in healthy women (n = 50) and women with lifestyle related diseases such as polycystic ovary syndrome (PCOS) (n = 50), gestational diabetes mellitus (GDM) (n = 44) and type 2 diabetes (DM2) (n = 43). A significant difference existed across groups for negative health habits (P = .012) with a trend for positive health habits (P = .06) elevated in women with PCOS. Women with DM2 had the highest amount of health care utilization including doctors office visits (P < .001), overnight hospital treatments (P < .001) and emergency room treatments (P = .01). Health practitioners would benefit from both encouraging positive health habits and addressing negative health habits. Furthermore, self-management and emphasizing the pivotal role patients’ have in managing their illness is important for optimizing health outcomes. Elevated health care utilization rates were observed in women with DM2 but there were no differences in positive health habits across sub-groups. Encouraging lifestyle modification in women with precursor diseases such as GDM and PCOS is vital in order to prevent progression to DM2.

Optimizing implementation of obesity prevention programs: A qualitative investigation within a large-scale randomized controlled trial

PURPOSE The prevalence of obesity in rural and remote areas is elevated in comparison to urban populations, highlighting the need for interventions targeting obesity prevention in these settings. Implementing evidence-based obesity prevention programs is challenging. This study aimed to investigate factors influencing the implementation of obesity prevention programs, including adoption, program delivery, community uptake, and continuation, specifically within rural settings. METHODS Nested within a large-scale randomized controlled trial, a qualitative exploratory approach was adopted, with purposive sampling techniques utilized, to recruit stakeholders from 41 small rural towns in Australia. In-depth semistructured interviews were conducted with clinical health professionals, health service managers, and local government employees. Open coding was completed independently by 2 investigators and thematic analysis undertaken. FINDINGS In-depth interviews revealed that obesity prevention programs were valued by the rural workforce. Program implementation is influenced by interrelated factors across: (1) contextual factors and (2) organizational capacity. Key recommendations to manage the challenges of implementing evidence-based programs focused on reducing program delivery costs, aided by the provision of a suite of implementation and evaluation resources. Informing the scale-up of future prevention programs, stakeholders highlighted the need to build local rural capacity through developing supportive university partnerships, generating local program ownership and promoting active feedback to all program partners. CONCLUSION We demonstrate that the rural workforce places a high value on obesity prevention programs. Our results inform the future scale-up of obesity prevention programs, providing an improved understanding of strategies to optimize implementation of evidence-based prevention programs.

Individual, social and environmental factors and their association with weight in rural-dwelling women

Objective: Obesity is a major public health concern and women living in rural settings present a high‐risk group. With contributing factors poorly explored, we evaluated their association with weight in rural Australian women.