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Background: Text message-delivered interventions have potential to prevent weight regain and maintain diet and physical activity behaviours through extending contact with participants following initial weight loss, lifestyle interventions. Using the RE-AIM Framework, this study evaluated the adoption, reach, implementation, effectiveness, and maintenance of an extended contact text-message intervention following the Healthy Living after Cancer (HLaC) program. HLaC was a 6-month, telephone-delivered intervention targeting healthy diet, physical activity and weight loss for adult cancer survivors, offered by Cancer Councils (CCs) in Australia., Methods: HLaC completers (n = 182) were offered extended contact via text messages for 6-months (HLaC+Txt). Text message content/frequency was individually tailored to participant's preferences, ascertained through two telephone-tailoring interviews with CC staff. Adoption (HLaC+Txt uptake among eligible CCs), reach (uptake by HLaC completers) and implementation (intervention cost/length; text dose) were assessed. The effectiveness of extended contact relative to historic controls was quantified by pre-to-post HLaC+Txt changes in self-reported: weight, moderate-vigorous physical activity (MVPA), fruit and vegetable intake, fat and fibre behaviour. Maintenance, following 6-months of noncontact for the intervention cohort, was assessed for these same variables. Semi-structured interviews with CC staff and participants contextualised outcomes., Results: HLaC+Txt was adopted by all four CCs who had delivered HLaC. In total, 115 participants commenced HLaC+Txt, with reach ranging across CCs from 47 to 80% of eligible participants. The mean number of weeks participants received the text message intervention ranged across CCs from 18.5-22.2 weeks. Participants received (median, 25th,75th percentile) 83 (48, 119) texts, ranging across CCs from 40 to 112. The total cost of HLaC+Txt delivery was on average $AUD85.00/participant. No meaningful (p < 0.05) differences in self-reported outcomes were seen between HLaC+Txt and control cohorts. After 6-months no contact the intervention cohort had maintained weight, fruit intake, fat and fibre index scores relative to end of HLaC+Txt outcomes. Participants/CC staff perceived an important intervention component was maintaining accountability., Conclusions: While feasible to implement, HLaC+Txt was not effective in the short term. However, intervention effects during the non-contact period suggest the program supports longer term maintenance of weight and diet behaviour. Intervention delivery in this real-world context highlighted key considerations for future implementation., Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12615000882527 (registered on 24/08/2015)., (© 2021. The Author(s).)

Background: The ACTIVATE Trial examined the efficacy of a wearable-based intervention to increase physical activity and reduce sedentary behavior in breast cancer survivors. This paper examines the effects of the intervention on health-related quality of life (HRQoL) and fatigue at 12 weeks (T2; end of intervention) and 24 weeks (T3; follow-up)., Methods: Inactive and postmenopausal women who had completed primary treatment for stage I-III breast cancer were randomized to intervention or waitlist control. Physical activity and sedentary behavior were measured by Actigraph and activPAL accelerometers at baseline (T1), end of the intervention (T2), and 12 weeks follow-up (T3). HRQoL and fatigue were measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Primary intervention effects were evaluated comparing intervention and waitlist group at T2 using repeated measures mixed effects models., Results: Overall, 83 women were randomized and trial retention was high (94%). A 4.6-point difference in fatigue score was observed between groups at T2 (95% CI: 1.3, 7.8) indicating improvement in fatigue profiles in the intervention group. In within groups analyses, the intervention group reported a 5.1-point increase in fatigue from baseline to T2 (95% CI: 2.0, 8.2) and a 3.3-point increase from baseline to T3 (95% CI: 0.1, 6.41)., Conclusions: Despite small improvements in fatigue profiles, no effects on HRQoL were observed. While the ACTIVATE Trial was associated with improvements in physical activity and sedentary behavior, more intensive or longer duration interventions may be needed to facilitate changes in HRQoL., (© 2019 John Wiley & Sons, Ltd.)

Background: This brief report examines the maintenance of moderate to vigorous physical activity (MVPA) and sedentary behavior changes approximately 12 weeks after the delivery of the ACTIVATE Trial primary intervention (use of the Garmin Vivofit 2 activity tracker coupled with a behavioral feedback and goal-setting session and 5 telephone-delivered health coaching sessions). We also examine the efficacy of an abridged intervention (use of the Garmin Vivofit 2 only) in the waitlist control group., Methods: A pre-post design was employed to examine the secondary aims of the ACTIVATE Trial (n = 80; mean age = 62 years). MVPA and sedentary behavior were measured using Actigraph and activPAL accelerometers after delivery of the primary intervention (T2), and again 12 weeks later (T3). Linear mixed models with random effects were used to examine within-group changes in MVPA and sitting time variables., Results: After the 12-week follow-up period, women in the primary intervention group had maintained their higher levels of MVPA (change from T2 to T3 = 14 min/wk; 95% CI = -18 to 46; P = .37). However, their sitting time increased slightly, by 7 min/d (95% CI = -20 to 34; P = .58), but it did not return to its preintervention level. After receiving the Garmin Vivofit 2, the waitlist control group increased their MVPA by 33 min/wk (95% CI = 3-64; P = .03) and reduced their sitting time by 38 min/d (95% CI = -69 to -7; P = .02) over the same 12-week period., Conclusion: The secondary outcomes from the ACTIVATE Trial suggest that wearable technology may generate sustainable changes in MVPA and sitting time. Wearable technology alone may be sufficient to change behavior, at least in the short term., (© 2019 American Cancer Society.)

Background: The benefits of an active lifestyle after a breast cancer diagnosis are well recognized, but the majority of survivors are insufficiently active. The ACTIVATE Trial examined the efficacy of an intervention (use of the Garmin Vivofit 2 activity monitor coupled with a behavioral feedback and goal-setting session and 5 telephone-delivered health coaching sessions) to increase moderate to vigorous physical activity (MVPA) and reduce sedentary behavior in breast cancer survivors., Methods: This randomized controlled trial recruited 83 inactive, postmenopausal women diagnosed with stage I-III breast cancer who had completed primary treatment. Participants were randomly assigned to the intervention group or to the control group, and the intervention was delivered over a 12-week period. MVPA and sedentary behavior were measured with Actigraph and activPAL accelerometers at baseline (T1) and at the end of the intervention (T2)., Results: Retention in the trial was high, with 80 (96%) of participants completing T2 data collection. At T2, there was a significant between-group difference in MVPA (69 min/wk; 95% CI = 22-116) favoring the intervention group. The trial resulted in a statistically significant decrease in both total sitting time and prolonged bouts (≥20 min) of sitting, with between-group reductions of 37 min/d (95% CI = -72 to -2) and 42 min/d (95% CI = -83 to -2), respectively, favoring the intervention group., Conclusion: Results from the ACTIVATE Trial suggest that the use of wearable technology presents an inexpensive and scalable opportunity to facilitate more active lifestyles for cancer survivors. Whether or not such wearable technology-based interventions can create sustainable behavioral change should be the subject of future research., (© 2019 American Cancer Society.)

Background: Physical activity is positively associated with survival and quality of life among breast cancer survivors. Despite these benefits, the majority of breast cancer survivors are insufficiently active. The potential health benefits of reducing sedentary behaviour (sitting time) in this population have not been extensively investigated. The ACTIVATE Trial will evaluate the efficacy of an intervention that combines wearable technology (the Garmin Vivofit2®) with traditional behavioural change approaches to increase physical activity and reduce sedentary behaviour performed by breast cancer survivors., Methods/design: This randomised controlled trial includes inactive, postmenopausal women diagnosed with stage I-III breast cancer who have completed their primary treatment. Participants are randomly assigned to the primary intervention group (Garmin Vivofit2®; behavioural feedback and goal setting session; and, five telephone-delivered health coaching sessions) or to the wait-list control group. The primary intervention is delivered over a 12-week period. The second 12-week period comprises a maintenance phase for the primary intervention group, and an abridged intervention (Garmin Vivofit2® only) for the wait-list control group. Moderate- to vigorous-intensity physical activity (MVPA) and sedentary behaviour are assessed by accelerometry at baseline (T1), end of intervention (T2), and end of maintenance phase (T3)., Discussion: The ACTIVATE Trial is one of the first studies to incorporate wearable technology into an intervention for cancer survivors. If the use of wearable technology (in combination with behaviour change strategies, or alone) proves efficacious, it may become an inexpensive and sustainable addition to the health promotion strategies available to health care providers in the cancer survivorship context., Trial Registration: ACTRN12616000175471., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Physical inactivity and sedentary behaviour are common amongst breast cancer survivors. These behaviours are associated with an increased risk of comorbidities such as heart disease, diabetes and other cancers. Commercially available, wearable activity trackers (WATs) have potential utility as behavioural interventions to increase physical activity and reduce sedentary behaviour within this population., Purpose: The purpose of the study is to explore the acceptability and usability of consumer WAT amongst postmenopausal breast cancer survivors., Methods: Fourteen participants tested two to three randomly assigned trackers from six available models (Fitbit One, Jawbone Up 24, Garmin Vivofit 2, Garmin Vivosmart, Garmin Vivoactive and Polar A300). Participants wore each device for 2 weeks, followed by a 1-week washout period before wearing the next device. Four focus groups employing a semi-structured interview guide explored user perceptions and experiences. We used a thematic analysis approach to analyse focus group transcripts., Results: Five themes emerged from our data: (1) trackers' increased self-awareness and motivation, (2) breast cancer survivors' confidence and comfort with wearable technology, (3) preferred and disliked features of WAT, (4) concerns related to the disease and (5) peer support and doctor monitoring were possible strategies for WAT application., Conclusions: WATs are perceived as useful and acceptable interventions by postmenopausal breast cancer survivors. Effective WAT interventions may benefit from taking advantage of the simple features of the trackers paired with other behavioural change techniques, such as specialist counselling, doctor monitoring and peer support, along with simple manual instructions.

Purpose: This pilot study assessed the feasibility, acceptability and outcomes of referring breast cancer survivors to the 'Get Healthy Service' (GHS), a state health-funded 6-month telephone-delivered lifestyle program., Methods: Pre-post study with eligible and consenting women following treatment for stages I-III breast cancer referred by nurses in a cancer treatment centre to the GHS. Feasibility was assessed via GHS uptake and completion; acceptability was assessed via patient satisfaction and nurse feedback. Changes in weight, physical activity, diet, quality of life (QoL) and fatigue from baseline to 6 months were examined., Results: Fifty-three women (mean ± SD body mass index, 31.0 ± 5.5 kg/m 2 ; age, 57.3 ± 10.0 years; 14.0 ± 7.1 months post-diagnosis; 43.4% born outside Australia, 49% high school or less education, 32.1% English as a second language) took up the GHS, with 62% completing the program. Almost all (92%) completers had high satisfaction ratings and breast nurses provided positive feedback. Findings from GHS completers (n = 33) show a statistically significant effect from baseline to 6 months for weight loss (mean ± SE; -2.4 ± 0.7 kg; p = 0.002) and total physical activity minutes per week (55 ± 18 min/week; p = 0.006). No significant changes in fruit or vegetable servings per day or takeaways and fast food frequency per week were observed. A significant improvement in mental QoL was observed (3.5 ± 1.6; p = 0.041), but not for physical QoL or fatigue., Conclusion: GHS referral appeared feasible, acceptable and effective for a diverse group of women following completion of treatment for breast cancer, yet more remains to be done to fully integrate GHS screening and referral into usual care.

Objective: To investigate the feasibility and safety of a 24-week exercise intervention, compared to control, in males with Barrett's oesophagus, and to estimate the effect of the intervention, compared to control, on risk factors associated with oesophageal adenocarcinoma development., Methods: A randomized controlled trial of an exercise intervention (60 minutes moderate-intensity aerobic and resistance exercise five days/week over 24 weeks; one supervised and four unsupervised sessions) versus attention control (45 minutes stretching five days/week over 24 weeks; one supervised and four unsupervised sessions) in inactive, overweight/obese (25.0-34.9 kg/m2) males with Barrett's oesophagus, aged 18-70 years. Primary outcomes were obesity-associated hormones relevant to oesophageal adenocarcinoma risk (circulating concentrations of leptin, adiponectin, interleukin-6, tumour necrosis factor-alpha, C-reactive protein, and insulin resistance [HOMA]). Secondary outcomes included waist circumference, body composition, fitness, strength and gastro-oesophageal reflux symptoms. Outcomes were measured at baseline and 24-weeks. Intervention effects were analysed using generalised linear models, adjusting for baseline value., Results: Recruitment was difficult in this population with a total of 33 participants recruited (target sample size: n = 80); 97% retention at 24-weeks. Adherence to the exercise protocol was moderate. No serious adverse events were reported. A statistically significant intervention effect (exercise minus control) was observed for waist circumference (-4.5 [95% CI -7.5, -1.4] cm; p < 0.01). Effects on primary outcomes were not statistically significant., Conclusion: This small, exploratory trial provides important information to inform future trial development including recruitment rates and estimates of effect sizes on outcomes related to oesophageal adenocarcinoma risk. Future trials should investigate a combined dietary and exercise intervention to achieve greater weight loss in this population and relax inclusion criteria to maximize recruitment., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000401257.

Obesity has been associated with poor health outcomes in breast cancer survivors. Thus, weight loss is recommended for overweight and obese survivors. We systematically reviewed studies (published up to July 2013) that evaluated behaviourally based, weight loss interventions in women with breast cancer exclusively. Completed randomized trials, single-arm trials and ongoing trials were reviewed. Within-group and between-group differences for weight loss were extracted, as was data on secondary outcomes, i.e. clinical biomarkers, patient-reported outcomes, adverse events. Ten completed randomized trials, four single-arm trials and five ongoing trials were identified. Statistically significant within-group weight loss was observed over periods of 2 to 18 months in 13 of the 14 trials, with six randomized and two single-arm trials observing mean weight loss ≥5%. Clinical biomarkers, psychosocial and patient-reported outcomes were measured in a small number of studies. No serious adverse events were reported. Only two trials assessed maintenance of intervention effects after the end-of-intervention and none reported on cost-effectiveness. The studies included in this review suggest that weight loss is feasible to achieve and is safe in women following treatment for breast cancer. Future studies should assess (and be powered for) a range of biomarker and patient-reported outcomes, and be designed to inform translation into practice., (© 2014 The Authors. obesity reviews © 2014 World Obesity.)

Objective: To explore barriers and solutions to addressing physical inactivity and prolonged sitting in the adult population of Oman., Design: Qualitative study involving semi-structured interviews that took place from October 2011 to January 2012. Participants were recruited through purposive sampling. Data collection and analysis was an iterative process; later interviews explored emerging themes. Interviews were audio-recorded and transcribed and continued until data saturation; this occurred by the tenth interviewee. Thematic content analysis was carried out, guided by an ecological model of health behaviour., Setting: Muscat, Oman., Subjects: Ten mid-level public health managers., Results: Barriers for physical inactivity were grouped around four themes: (i) intrapersonal (lack of motivation, awareness and time); (ii) social (norms restricting women's participation in outdoor activity, low value of physical activity); (iii) environment (lack of places to be active, weather); and (iv) policy (ineffective health communication, limited resources). Solutions focused on culturally sensitive interventions at the environment (building sidewalks and exercise facilities) and policy levels (strengthening existing interventions and coordinating actions with relevant sectors). Participants' responses regarding sitting time were similar to, but much more limited than those related to physical inactivity, except for community participation and voluntarism, which were given greater emphasis as possible solutions to reduce sitting time., Conclusions: Given the increasing prevalence of chronic disease in Oman and the Arabian Gulf, urgent action is required to implement gender-relevant public health policies and programmes to address physical inactivity, a key modifiable risk factor. Additionally, research on the determinants of physical inactivity and prolonged sitting time is required to guide policy makers.

Issue Addressed: This paper determined the test-retest reliability and criterion validity of a modified version of the Active Australia Survey (AAS) and whether these properties varied across participants' activity levels., Methods: Participants (n=63) responded to repeat administrations of the AAS and wore an accelerometer for 7 days. Analyses used Spearman's rho (rs,) or weighted kappa (κ) and Bland-Altman methods. Variation in mean difference and 95% limits of agreement (LOA) across average levels of activity were tested by linear regression., Results: Reliability correlations (rs; 95% confidence intervals (CI)) for minutes per week ranged from 0.40 (0.16, 0.59) to 0.80 (0.68, 0.87). For days per week, the agreement (κ; 95% CI) between administrations ranged from 0.43 (0.34, 0.73) to 0.83 (0.61, 0.93). There was a small mean difference between administrations (-8.46 moderate-vigorous minutes per week); 95% LOA widened as participants' average activity levels increased. Validity correlations (rs; 95% CI) for minutes per week ranged from 0.50 (0.28, 0.66) to 0.61 (0.43, 0.75). For days per week, the agreement (κ; 95% CI) ranged from 0.35 (0.10, 0.50) to 0.61 (0.29, 0.87). The mean difference between the AAS and accelerometer and 95% LOA both varied with participants' activity levels., Conclusions: The reliability and validity of the modified AAS were better than those of previously published versions, but varied according to participants' activity levels. So what? In this study, participants who engaged in more activity had more measurement error than less active participants. This proportionality will have important implications for cross-sectional and intervention studies. This phenomenon needs to be examined for other self-reported physical activity measures.

Purpose: Maintaining physical activity and dietary improvements achieved during an intervention is important for the long-term health outcomes of breast cancer survivors. This review aimed to determine: (a) the proportion of physical activity and/or dietary intervention trials in breast cancer survivors that assessed post-intervention maintenance of outcomes, (b) the proportion of trials that achieved successful post-intervention maintenance of outcomes, and (c) the sample, intervention, and methodological characteristics common among trials that achieved successful post-intervention maintenance of outcomes., Methods: A structured search of PubMed, CINAHL, Medline via Ovid, Web of Science, CENTRAL, and PsycInfo was conducted for articles published until March 2012. Included trials had to evaluate a randomized controlled trial of a physical activity and/or dietary behavior change intervention that targeted breast cancer survivors and report on between-group differences of behavioral outcomes at end-of-intervention and at least 3 months post-intervention follow-up. Methodological quality of included trials was also assessed., Results: The search resulted in 1,298 publications. Of 63 identified trials that assessed end-of-intervention outcomes, 10 (16 %) assessed post-intervention maintenance of outcomes; four of these 10 trials achieved successful maintenance. Due to the limited number and heterogeneity of the four trials, few commonalities in sample, intervention, and methodological characteristics were identified., Conclusion: Assessing post-intervention maintenance of physical activity and dietary outcomes in breast cancer survivors is rare. There is a pressing need to direct more attention to this issue to inform the development of interventions to improve the long-term health outcomes for the growing number of breast cancer survivors., Implications for Cancer Survivors: For breast cancer survivors, maintaining regular physical activity and a healthy diet are important to enhancing health and well-being over the long-term. More research is needed to identify the best ways of supporting survivors to make and maintain these lifestyle changes.

Objective: To inform public health approaches for chronic disease prevention, the present study identified sociodemographic, anthropometric and behavioural correlates of work, transport and leisure physical inactivity and sitting time among adults in Oman., Design: Cross-sectional study using the WHO STEPwise study methodology., Setting: Sur City, Oman., Subjects: Men and women aged 20 years and older (n = 1335) in the Sur City Healthy Lifestyle Study who had complete data for demographic variables (gender, age, education, work status and marital status), BMI and behavioural risk factors – smoking and dietary habits plus physical inactivity and sitting time (the outcome variables)., Results: The highest level of physical inactivity was in the leisure domain (55.4 %); median sitting time was about 2 h/d. Gender-stratified logistic regression models found that the statistically significant (P < 0.05) correlates of inactivity (in one or more domains) were age, work status and fruit and vegetable intake in women, and age, education, work status, marital status and BMI in men. Gender-stratified linear regression models found that the statistically significant correlates of sitting time were age, work status and BMI in women and education in men., Conclusions: Findings suggest that public health interventions need to be gender responsive and focus on domain-specific physical inactivity. In the Omani context, this might include gender-segregated exercise facilities to promote leisure physical activity among women and walking-friendly environmental initiatives to promote transport physical activity among men. Further evidence on barriers to physical activity and factors that influence prolonged sitting is required to develop relevant public health interventions.

Purpose: To describe the process of translating an evidence-based, telephone-delivered physical activity and dietary behavior change intervention from research into practice., Design: Descriptive case study., Setting/subjects: Nongovernment, primary medical care-based community health organization., Intervention: Telephone-delivered intervention targeting physical activity and diet in primary medical care patients., Measures/analysis: Systematic documentation of process outcomes related to intervention adoption and adaptation., Results: Research-community partnerships were critical in facilitating translation, including (1) an initial competitive advantage within a State Health Department-funded preventive health initiative; (2) advocacy to ensure the adoption of the intervention, (3) subsequent support for the adaptation of program elements to ensure fit of the program with the community organization's objectives and capacities, while maintaining feasible elements of fidelity with the original evidence-based program; (4) the integration of program management and evaluation systems within the community organization; and (5) ongoing support for staff members responsible for program delivery and evaluation. Preliminary process evaluation of the Optimal Health Program supports the acceptability and feasibility of the program within community practice., Conclusions: INTERVENTION characteristics central to adoption can be influenced by research-community partnerships. It is likely that evidence-based interventions will need to be adapted for delivery within the real world. Researchers should endeavor to provide training and support to ensure, as much as possible, fidelity with the original program, and that the relevant adaptations are evidence based.

Background: With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown., Methods: Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention), characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups., Results: Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also unexpected and detrimental. Physical activity screening (alone or in combination with diet) resulted in improved intervention effects for physical activity, while fruit and vegetable screening had no impact on intervention effects for these outcomes. All three types of screening impacted detrimentally on intervention effects for behaviours not being targeted by screening., Conclusions: Behavioural screening may have desirable and undesirable consequences in the context of multiple behaviour intervention trials, and thus its potential merits and pitfalls should be carefully considered.

Background: Meaningful improvement in physical activity among control group participants in lifestyle intervention trials is not an uncommon finding, and may be partly explained by participant characteristics. This study investigated which baseline demographic, health and behavioural characteristics were predictive of successful improvement in physical activity in usual care group participants recruited into a telephone-delivered physical activity and diet intervention trial, and descriptively compared these characteristics with those that were predictive of improvement among intervention group participants., Methods: Data come from the Logan Healthy Living Program, a primary care-based, cluster-randomized controlled trial of a physical activity and diet intervention. Multivariable logistic regression models examined variables predictive of an improvement of at least 60 minutes per week of moderate-to-vigorous intensity physical activity among usual care (n = 166) and intervention group (n = 175) participants., Results: Baseline variables predictive of a meaningful change in physical activity were different for the usual care and intervention groups. Being retired and completing secondary school (but no further education) were predictive of physical activity improvement for usual care group participants, whereas only baseline level of physical activity was predictive of improvement for intervention group participants. Higher body mass index and being unmarried may also be predictors of physical activity improvement for usual care participants., Conclusion: This is the first study to examine differences in predictors of physical activity improvement between intervention group and control group participants enrolled in a physical activity intervention trial. While further empirical research is necessary to confirm findings, results suggest that participants with certain socio-demographic characteristics may respond favourably to minimal intensity interventions akin to the treatment delivered to participants in a usual care group. In future physical activity intervention trials, it may be possible to screen participants for baseline characteristics in order to target minimal-intensity interventions to those most likely to benefit. (Australian Clinical Trials Registry, http://www.anzctr.org.au/default.aspx, ACTRN012607000195459).

Background: By 2025, it is estimated that approximately 1.8 million Australian adults (approximately 8.4% of the adult population) will have diabetes, with the majority having type 2 diabetes. Weight management via improved physical activity and diet is the cornerstone of type 2 diabetes management. However, the majority of weight loss trials in diabetes have evaluated short-term, intensive clinic-based interventions that, while producing short-term outcomes, have failed to address issues of maintenance and broad population reach. Telephone-delivered interventions have the potential to address these gaps., Methods/design: Using a two-arm randomised controlled design, this study will evaluate an 18-month, telephone-delivered, behavioural weight loss intervention focussing on physical activity, diet and behavioural therapy, versus usual care, with follow-up at 24 months. Three-hundred adult participants, aged 20-75 years, with type 2 diabetes, will be recruited from 10 general practices via electronic medical records search. The Social-Cognitive Theory driven intervention involves a six-month intensive phase (4 weekly calls and 11 fortnightly calls) and a 12-month maintenance phase (one call per month). Primary outcomes, assessed at 6, 18 and 24 months, are: weight loss, physical activity, and glycaemic control (HbA1c), with weight loss and physical activity also measured at 12 months. Incremental cost-effectiveness will also be examined. Study recruitment began in February 2009, with final data collection expected by February 2013., Discussion: This is the first study to evaluate the telephone as the primary method of delivering a behavioural weight loss intervention in type 2 diabetes. The evaluation of maintenance outcomes (6 months following the end of intervention), the use of accelerometers to objectively measure physical activity, and the inclusion of a cost-effectiveness analysis will advance the science of broad reach approaches to weight control and health behaviour change, and will build the evidence base needed to advocate for the translation of this work into population health practice., Trial Registration: ACTRN12608000203358.

Background: Physical activity and dietary behavior changes are important to both the primary prevention and secondary management of the majority of our most prevalent chronic conditions (i.e., cardiovascular disease, hypertension, type 2 diabetes, breast and colon cancer). With over 85% of Australian adults visiting a general practitioner each year, the general practice setting has enormous potential to facilitate wide scale delivery of health behaviour interventions. However, there are also many barriers to delivery in such settings, including lack of time, training, resources and remuneration. Thus there is an important need to evaluate other feasible and effective means of delivering evidence-based physical activity and dietary behaviour programs to patients in primary care, including telephone counseling interventions., Methods: Using a cluster randomized design with practice as the unit of randomization, this study evaluated a telephone-delivered intervention for physical activity and dietary change targeting patients with chronic conditions (type 2 diabetes or hypertension) recruited from primary care practices in a socially disadvantaged community in Queensland, Australia. Ten practices were randomly assigned to the telephone intervention or to usual care, and 434 patients were recruited. Patients in intervention practices received a workbook and 18 calls over 12 months. Assessment at baseline, 4-, 12- and 18-months allows for assessment of initial change and maintenance of primary outcomes (physical activity and dietary behavior change) and secondary outcomes (quality of life, cost-effectiveness, support for health behavior change)., Conclusions: This effectiveness trial adds to the currently limited number of telephone-delivered intervention studies targeting both physical activity and dietary change. It also addresses some of the shortcomings of previous trials by targeting patients from a disadvantaged community, and by including detailed reporting on participant representativeness, intervention implementation and cost-effectiveness, as well as an evaluation of maintenance of health behavior change.