Effect of a low-intensity, self-management lifestyle intervention on knee pain in community-based young to middle-aged rural women: a cluster randomised controlled trial.

BACKGROUND: Knee 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. METHODS: A 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. RESULTS: Thirty-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). CONCLUSIONS: In 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 REGISTRATION: ACTRN12612000115831 , registered 24 January 2012.

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. 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.

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/m(2) (+/- 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 -0.48 kg (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.

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.

Engaging rural women in healthy lifestyle programs: insights from a randomized controlled trial.

BACKGROUND: The obesity epidemic is well established, particularly in rural settings. Programs promoting healthy lifestyles for rural women are urgently needed; however, participant engagement is challenging. In the context of a large randomized controlled trial targeting the prevention of weight gain in rural women, we explored successful recruitment strategies and aimed to understand participants' barriers, enablers and reasons for program participation. METHODS: We recruited women (aged 18-55 years) from the general rural Australian population. A mixed-methods approach was applied to explore factors that influenced program participation, including quantitative questionnaires for all participants (n = 649) and qualitative semi-structured interviews conducted for a subgroup of participants (n = 45). Data were collected at three time points: baseline, 6 and 12 months post program commencement. RESULTS: We recruited 649 rural women through a community communication and partnering strategy, a program marketing campaign and mobilization of social networks. Program participants were diverse across education and income levels and were representative of the wider Australian regional population. Factors that influenced program engagement were divided into personal (perceived program benefits and program accessibility) and social (peer persuasion and support). Identified enablers included convenience of the program location, perceived program utility, such as weight management and optimization of lifestyle choices, as well as attending the program with peer support. Barriers to engagement, which are likely exacerbated in rural communities included lack of anonymity, self-consciousness and segregated social networks in rural settings. Participants reported that eliciting local support and maximizing publicity is fundamental to improving future program engagement. CONCLUSION: Multiple program promotion strategies including communication, marketing and partnering, as well as mobilization of social networks and peer persuasion, enabled engagement of rural women into a healthy lifestyle program. These recruitment strategies are consistent with successful strategies utilized previously to recruit urban-dwelling women into lifestyle programs. Future engagement efforts in rural settings could be enhanced by hosting multiple sessions within existing socio-cultural networks and assuring participants that they will not need to share their personal health information with others in their community. TRIAL REGISTRATION: Australia & New Zealand Clinical Trial Registry. Trial number ACTRN12612000115831. Date of registration 24 January 2012.

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.

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

BACKGROUND: To 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. METHODS: Here 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. DISCUSSION: Implementing 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 REGISTRATION: ANZ clinical trial registry ACTRN12612000115831. Date of registration 24/01/2012.

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.