BackgroundObesity 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 FindingsWe 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.ConclusionsA 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.

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

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-015-1995-8) contains supplementary material, which is available to authorized users.

BackgroundPreventing 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.MethodsIn-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.ParticipantsA 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.ResultsFour 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.ConclusionInitiating 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 RegistrationAustralia & New Zealand Clinical Trial Registry ACTRN12612000115831 www.anzctr.org.au

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.

BackgroundKnee pain is common with obesity and weight gain being important risk factors. Previous clinical trials have focused on overweight or obese adults with knee pain and osteoarthritis and demonstrated modest effects of intense weight loss programs on reducing knee pain despite very significant weight loss. There has been no lifestyle intervention that targets community-based adults to test its effect on prevention of knee pain. We aimed to determine the effect of a simple low-intensity self-management lifestyle intervention (HeLP-her), proven in randomised controlled trials to improve lifestyle and prevent weight gain, on knee pain in community-based young to middle-aged rural women.MethodsA 1-year pragmatic, cluster randomised controlled trial was conducted in 649 community-based women (aged 18–50 years) to receive either the HeLP-her program (consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual) or one general women’s health education session. Secondary analyses were performed in 390 women who had knee pain measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and 12-month follow-up. “Any knee pain” was defined as a WOMAC pain score ≥ 1. Knee pain worsening was defined as an increase in WOMAC pain score over 12 months.ResultsThirty-five percent of women had “any knee pain” at baseline. The risk of knee pain worsening did not differ between the intervention and control groups over 12 months. For women with any knee pain at baseline, those in the intervention arm had a lower risk of knee pain worsening compared with those in the control arm (OR 0.37, 95% CI 0.14–1.01, p = 0.05), with a stronger effect observed in women with body mass index ≥ 25 kg/m2 (OR 0.28, 95% CI 0.09–0.87, p = 0.03).ConclusionsIn community-based young to middle-aged women, a simple low-intensity lifestyle program reduced the risk of knee pain worsening in those with any knee pain at baseline, particularly in those overweight or obese. Pragmatic lifestyle programs such as HeLP-her may represent a feasible lifestyle intervention to reduce the burden of knee pain in the community.Trial registrationACTRN12612000115831, registered 24 January 2012.Electronic supplementary materialThe online version of this article (10.1186/s13075-018-1572-5) contains supplementary material, which is available to authorized users.

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. Methods: Women aged 18–50 years of any body mass index (BMI) were recruited between October 2012 and April 2013 as part of a larger, randomised controlled trial within 42 rural towns. Measured weight and height as well as self‐reported measures of individual health, physical activity, dietary intake, self‐management, social support and environmental perception were collected. Statistical analysis included linear regression for continuous variables as well as chi‐squared and logistic regression for categorical variables with all results adjusted for clustering. Results: 649 women with a mean baseline age and BMI of 39.6±6.7 years and 28.8±6.9 kg/m2 respectively, were studied. Overall, 65% were overweight or obese and 60% overall reported recent weight gain. There was a high intention to self‐manage weight, with 68% attempting to lose weight recently, compared to 20% of women reporting health professional engagement for weight management. Obese women reported increased weight gain, energy intake, sitting time and prevalence of pre‐existing health conditions. There was an inverse relationship between increased weight and scores for self‐management, social support and health environment perception. Conclusions: Many women in rural communities reported recent weight gain and were attempting to self‐manage their weight with little external support. Implications for public health: Initiatives to prevent weight gain require a multifaceted approach, with self‐management strategies and social support in tandem with building a positive local environmental perception.

BackgroundThe Healthy Lifestyle Program for women (HeLP-her) is a low-intensity, self-management program which has demonstrated efficacy in preventing excess weight gain in women. However, little is known about the implementation, reach, and sustainability of low-intensity prevention programs in rural settings, where risk for obesity in women is higher than urban settings. We aimed to evaluate a low-intensity healthy lifestyle program delivered to women in a rural setting to inform development of effective community prevention programs.MethodsA mixed method hybrid implementation and evaluation study, guided by the RE-AIM framework (addressing the Reach, Effectiveness, Adoption, Implementation, and Maintenance), was undertaken. Data collection tools included anthropometric measures, program checklists, questionnaires, and semi-structured interviews with participants and local stakeholders. The RE-AIM self-audit tool was applied to assess evaluation rigor.ResultsSix hundred and forty-nine women from 41 relatively socio-economic disadvantaged communities in Australia participated: mean age 39.6 years (±SD 6.7) and body mass index of 28.8 kg/m2 (±SD 6.9). A between-group weight difference of −0.92 kg (95% CI −1.67 to −0.16) showed program effectiveness. Reach was broad across 41 towns with 62% of participants reporting influencing some of the health behaviors of their families. Strong implementation fidelity was achieved with good retention rates at 1 year (76%) and high participant satisfaction (82% of participants willing to recommend this program). Over 300 multi-level community partnerships were established supporting high adoption. Stakeholders reported potential capacity to implement and sustain the prevention program in resource poor rural settings, due to the low-intensity design and minimal resources required.ConclusionsOur comprehensive RE-AIM evaluation demonstrates that an evidence-based obesity prevention program can be successfully implemented in real-world settings. The program achieved broad reach, effectiveness, and satisfaction at the community and stakeholder level, revealing potential for program sustainability. The evaluation addressed implementation knowledge gaps to support future obesity prevention program scale-up.Trial registrationAustralian and New Zealand Clinical Trial Registry ACTRN 12612000115831 [http://www.anzctr.org.au/].Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-016-0521-4) contains supplementary material, which is available to authorized users.