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The 'Women's Lifestyle Study', 2-year randomized controlled trial of physical activity counselling in primary health care: rationale and study design.

ABSTRACT: BACKGROUND:Physical inactivity is an independent risk factor for diabetes and heart disease. There is evidence that increasing physical activity can reduce the risk of developing these chronic diseases, but less evidence about effective ways to increase adherence to physical activity. Interventions are therefore needed that produce sustained increases in adherence to physical activity, are cost-effective and improve clinical endpoints. METHODS:The Women's Lifestyle Study is a two year randomized controlled trial involving a nurse-led intervention to increase physical activity in 40-74 year old physically inactive women recruited from primary care. Baseline measures were assessed in a face-to-face interview with a primary care nurse. The intervention involved delivery of a 'Lifestyle script' by a primary care nurse followed by telephone counselling for nine months and a face-to-face nurse visit at six months. Outcome measurements are assessed at 12 and 24 months. The primary outcome is physical activity measured using a validated physical activity questionnaire. Secondary outcomes include blood pressure, weight, waist circumference, physical fitness (step test), serum HbA1c, fasting glucose, lipids, insulin, and quality of life (SF36). Costs were measured prospectively to allow a subsequent cost-effectiveness evaluation if the trial is positive. DISCUSSION:Due to report in 2008, the Women's Lifestyle Study tests the effectiveness of an enhanced low-cost, evidence-based intervention in increasing physical activity, and improving cardiovascular and diabetes risk indicators over two years. If successful in demonstrating improvements in health outcomes, this randomized controlled trial will be the first to demonstrate long-term cardiovascular and diabetes risk health benefit, in addition to improvements in physical activity, from a sustainable physical activity intervention based in primary care. TRIAL REGISTRATION:Australian Clinical Trials Registry (ACTR), ACTRN012605000490673.

SUBMITTER: Rose SB

PROVIDER: S-EPMC1971069 | biostudies-literature | 2007 Jul

REPOSITORIES: biostudies-literature

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The 'Women's Lifestyle Study', 2-year randomized controlled trial of physical activity counselling in primary health care: rationale and study design.

Rose Sally B SB Lawton Beverley A BA Elley C Raina CR Dowell Anthony C AC Fenton Anna J AJ

BMC public health 20070723

<h4>Background</h4>Physical inactivity is an independent risk factor for diabetes and heart disease. There is evidence that increasing physical activity can reduce the risk of developing these chronic diseases, but less evidence about effective ways to increase adherence to physical activity. Interventions are therefore needed that produce sustained increases in adherence to physical activity, are cost-effective and improve clinical endpoints.<h4>Methods</h4>The Women's Lifestyle Study is a two ...[more]

PMID: 17645805

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Project description:Declining physical activity is associated with a rising burden of global disease. There is little evidence about effective ways to increase adherence to physical activity. Therefore, interventions are needed that produce sustained increases in adherence to physical activity and are cost-effective. The purpose is to assess the effectiveness of a primary care physical activity intervention in increasing adherence to physical activity in the general population seen in primary care.Randomized controlled trial with systematic random sampling. A total of 424 subjects of both sexes will participate; all will be over the age of 18 with a low level of physical activity (according to the International Physical Activity Questionnaire, IPAQ), self-employed and from 9 Primary Healthcare Centres (PHC). They will volunteer to participate in a physical activity programme during 3 months (24 sessions; 2 sessions a week, 60 minutes per session).Participants from each PHC will be randomly allocated to an intervention (IG) and control group (CG). The following parameters will be assessed pre and post intervention in both groups: (1) health-related quality of life (SF-12), (2) physical activity stage of change (Prochaska's stages of change), (3) level of physical activity (IPAQ-short version), (4) change in perception of health (vignettes from the Cooperative World Organization of National Colleges, Academies, and Academic Associations of Family Physicians, COOP/WONCA), (5) level of social support for the physical activity practice (Social Support for Physical Activity Scale, SSPAS), and (6) control based on analysis (HDL, LDL and glycated haemoglobin). Participants' frequency of visits to the PHC will be registered over the six months before and after the programme. There will be a follow up in a face to face interview three, six and twelve months after the programme, with the reduced version of IPAQ, SF-12, SSPAS, and Prochaska's stages.The pilot study showed the effectiveness of an enhanced low-cost, evidence-based intervention in increased physical activity and improved social support. If successful in demonstrating long-term improvements, this randomised controlled trial will be the first sustainable physical activity intervention based in primary care in our country to demonstrate long-term adherence to physical activity.A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov ID: NCT00714831.

Project description:BackgroundMidlife women are at an elevated risk for cardiovascular disease (CVD) and associated mortality. Those who have additional risk conditions such as obesity or hypertension report specific barriers to engaging in cardioprotective behaviors such as physical activity (PA). Considerable effort has been devoted to understanding PA determinants and designing interventions for midlife women, although with suboptimal success, as increasing PA could meaningfully attenuate CVD risk. An updated approach to understanding PA among midlife women could improve upon existing resources by focusing on novel psychosocial influences on PA in this population (ie, body satisfaction, social interactions, social comparisons, mood state) and within-person relations between these influences and PA in the natural environment.ObjectiveThe overarching goal of Project WHADE (Women's Health And Daily Experiences) is to use an ecological momentary assessment (EMA) approach to capture ecologically valid relations between midlife women's psychosocial experiences and PA as they engage in their normal daily activities. The primary aim of the study is to identify within-person psychosocial predictors of variability in PA (ie, experiences associated with higher vs lower PA for a given individual).MethodsMidlife women (aged 40-60 years) with one or more additional risk markers for CVD (eg, hypertension) will be recruited from primary care clinics and the general community (target n=100). Eligible women will complete an initial survey and a face-to-face baseline session before engaging in a 10-day EMA protocol. Psychosocial experiences will be assessed using a brief self-report via a smartphone 5 times per day, and PA will be assessed throughout waking hours using a research-grade monitor. Participants will return for a brief exit interview at the end of 10 days. Multilevel models that address the nested structure of EMA data will be used to evaluate the study aims.ResultsRecruitment and enrollment are ongoing, and a total of 75 women have completed the protocol to date. Data collection is expected to be completed in Fall 2020.ConclusionsProject WHADE is designed to identify naturally occurring psychosocial experiences that predict short-term variability in midlife women's PA. As such, the results of this study should advance the current understanding of PA among midlife women by providing further insight into within-person psychosocial influences on PA in this group. In the future, this information could help inform the design of interventions for this population.International registered report identifier (irrid)DERR1-10.2196/19044.

Project description:Chronic obstructive pulmonary disease (COPD) is a progressive, debilitating disease associated with significant clinical burden and is estimated to affect 15 million individuals in the US. Although a large number of individuals are diagnosed with COPD, many individuals still remain undiagnosed due to the slow progression of the disorder and lack of recognition of early symptoms. Not only is there under-diagnosis but there is also evidence of sub-optimal evidence-based treatment of those who have COPD. Despite the development of international COPD guidelines, many primary care physicians who care for the majority of patients with COPD are not translating this evidence into effective clinical practice.This paper describes the design and rationale for a randomized, cluster design trial (RCT) aimed at translating the COPD evidence-based guidelines into clinical care in primary care practices. During Phase 1, a needs assessment evaluated barriers and facilitators to implementation of COPD guidelines into clinical practice through focus groups of primary care patients and providers. Using formative evaluation and feedback from focus groups, three tools were developed. These include a computerized patient activation tool (an interactive iPad with wireless data transfer to the spirometer); a web-based COPD guideline tool to be used by primary care providers as a decision support tool; and a COPD patient education toolkit to be used by the practice team. During phase II, an RCT will be performed with one year of intervention within 30 primary care practices. The effectiveness of the materials developed in Phase I are being tested in Phase II regarding physician performance of COPD guideline implementation and the improvement in the clinically relevant outcomes (appropriate diagnosis and management of COPD) compared to usual care. We will also examine the use of a patient activation tool - 'MyLungAge' - to prompt patients at risk for or who have COPD to request spirometry confirmation and to request support for smoking cessation if a smoker.Using a multi-modal intervention of patient activation and a technology-supported health care provider team, we are testing the effectiveness of this intervention in activating patients and improving physician performance around COPD guideline implementation.ClinicalTrials.gov, NCT01237561.

Project description:BackgroundPhysical activity offers major health benefits and counselling for it should be integrated into the medical consultation. Based on the literature, the personal health behaviour of the physician (including physical activity) is associated with his/her approach to counselling patients. Our hypothesis is that family doctors (FD) in Estonia are physically active and their recommendation to counsel patients with chronic diseases to use physical activity is high. The study was also interested in how FDs value physical activity among other important determinants of a healthy lifestyle, e.g. nutrition, non-consumption of alcohol, and non-smoking.MethodsPhysicians on the electronic list were contacted by e-mail and sent a questionnaire. The first part assessed physical activity by the International Physical Activity Questionnaire (IPAQ) short form. Self-reported physical activity during one week was calculated as total physical activity in minutes per week (MET min/week). The second part of the questionnaire included questions about the counselling of patients with chronic disease concerning their physical activity and a healthy lifestyle. The study focused on female FDs because 95% of the FDs in Estonia are women and to avoid bias related to gender.Results198 female FDs completed the questionnaire. 92% reported that they exercised over the past 7 days to a moderate or high level of physical activity. Analysis revealed no statistically significant relationship between the level of physical activity and general characteristics (age, living area, body mass index [BMI], time spent sitting). FDs reported that patients with heart problems, diabetes, and obesity seek their advice on physical activity more often than patients with depression. Over 94% of the FDs claimed that they counsel their patients with chronic diseases about exercising. According to the FDs' reports, the most important topic in counselling patients for a healthy lifestyle was physical activity.ConclusionThis study showed that female FDs are physically active. The level of physical activity is not related to their age, BMI, living area, or time spent sitting. Also, FDs reported that promotion of physical activity is part of their everyday work.

Project description:BackgroundPrenatal care has been validated to provide medical and educational counselling intended to reduce the risk of adverse pregnancy conditions and improve the maternal and fetal outcomes. Prenatal targeted information regarding nutrition, lifestyle, and weight gain is predictive of meeting Institute of Medicine (IOM) 2009 gestational weight gain (GWG) guidelines. There is limited information about women's experiences with these prenatal counselling domains, particularly in women who do not meet GWG recommendations. The objective of this study was to evaluate the impact of women's recall of prenatal counselling and its effect on meeting their GWG within guidelines in a prospective, community-based pregnancy cohort.MethodsA sample of 2909 women with singleton pregnancies was drawn from the prospective community-based pregnancy cohort All Our Families from Alberta, Canada. Women were stratified into three GWG groups, adequate, inadequate, and excessive GWG, based on pre-pregnancy BMI and the adherence to the Institute of Medicine weight gain in pregnancy guidelines. At less than 25 and 34 to 36?weeks' gestation, maternal socio-demographic information and women's recall of prenatal counselling experiences was collected through self-administered questionnaires. Multivariate logistic regression analyses tested GWG strata impact on women's recall of the prenatal counselling advice in eight domains of nutrition, lifestyle, and weight management during pregnancy.ResultsAdequate GWG was reached by 35.9% of women, 46.5% gained excessive and 17.6% gained inadequate weight. Women who were overweight and obese prior to pregnancy were more likely to gain excessive weight than women who were normal weight (OR 3.3, 95% CI 2.6-4.1; and OR 2.9, 95% CI 2.1-3.9, respectively). Most women reported having no difficulties in finding prenatal care, felt comfortable with their health care provider and were satisfied with the answers received. There was no difference in the recall of prenatal advice received in any of the eight domains of prenatal counselling assessed among women with appropriate and non-optimal GWG.ConclusionWomen with adequate and non-optimal GWG received comparable prenatal counselling on nutrition, weight gain, and lifestyle modifications. There remain missed opportunities in targeting prenatal counselling advice to women at risk for suboptimal or excessive GWG.

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The 'Women's Lifestyle Study', 2-year randomized controlled trial of physical activity counselling in primary health care: rationale and study design.

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The 'Women's Lifestyle Study', 2-year randomized controlled trial of physical activity counselling in primary health care: rationale and study design.

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