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      "Booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods: internal pilot and feasibility study

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          Abstract

          Background

          Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. A randomised controlled trial is needed to assess whether providing motivational interviewing, three months after giving initial advice, sustains physical activity levels in those who recently became physically active. This paper reports the results of an internal pilot study designed to test the feasibility of the study in terms of recruitment, per protocol delivery of the intervention and retention at three months.

          Methods

          Participants were: aged 40-64 years; resident in deprived areas of Sheffield, UK; and, had recently become physically active as a result of using a brief intervention following an invitation from a mass mailout. Interventions: Motivational Interviewing 'boosters' aimed at sustaining change in physical activity status delivered face-to-face or over the telephone compared with no further intervention. Outcomes of the feasibility study: recruitment of 60 participants from mailout of 3,300; retention of 45 participants with 3-month follow-up accelerometry measurements; 70% of those randomised to boosters receiving intervention per protocol. Sample size and power were recalculated using the accelerometry data collected.

          Results

          Forty-seven participants were randomised (78% of the feasibility target); 37 participants were retained at three months, 29 with at least four days of accelerometry data (64% of the feasibility target); 79% of those allocated boosters received them per protocol (surpassing the feasibility target). The proposed sample size of 600 was confirmed as appropriate and power is expected to be sufficient to detect a difference between groups.

          Conclusions

          The main study will continue with the original recruitment target of 600 participants but to ensure feasibility, it is necessary to increase recruitment and improve the numbers of those followed-up who have evaluable data. Strategies will include increasing the number of initial invitations sent out and improving the training of research assistants and participants in the positioning of the accelerometer.

          Trial Registration

          ISRCTN: ISRCTN56495859, ClinicalTrials (NCT): NCT00836459

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          Most cited references17

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          In search of how people change. Applications to addictive behaviors.

          How people intentionally change addictive behaviors with and without treatment is not well understood by behavioral scientists. This article summarizes research on self-initiated and professionally facilitated change of addictive behaviors using the key trans-theoretical constructs of stages and processes of change. Modification of addictive behaviors involves progression through five stages--pre-contemplation, contemplation, preparation, action, and maintenance--and individuals typically recycle through these stages several times before termination of the addiction. Multiple studies provide strong support for these stages as well as for a finite and common set of change processes used to progress through the stages. Research to date supports a trans-theoretical model of change that systematically integrates the stages with processes of change from diverse theories of psychotherapy.
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            Comparison of lifestyle and structured interventions to increase physical activity and cardiorespiratory fitness: a randomized trial.

            Even though the strong association between physical inactivity and ill health is well documented, 60% of the population is inadequately active or completely inactive. Traditional methods of prescribing exercise have not proven effective for increasing and maintaining a program of regular physical activity. To compare the 24-month intervention effects of a lifestyle physical activity program with traditional structured exercise on improving physical activity, cardiorespiratory fitness, and cardiovascular disease risk factors. Randomized clinical trial conducted from August 1, 1993, through July 31, 1997. Sedentary men (n = 116) and women (n = 119) with self-reported physical activity of less than 36 and 34 kcal/kg per day, respectively. Six months of intensive and 18 months of maintenance intervention on either a lifestyle physical activity or a traditional structured exercise program. Primary outcomes were physical activity assessed by the 7-Day Physical Activity Recall and peak oxygen consumption (VO2peak) by a maximal exercise treadmill test. Secondary outcomes were plasma lipid and lipoprotein cholesterol concentrations, blood pressure, and body composition. All measures were obtained at baseline and at 6 and 24 months. Both the lifestyle and structured activity groups had significant and comparable improvements in physical activity and cardiorespiratory fitness from baseline to 24 months. Adjusted mean changes (95% confidence intervals [CIs]) were 0.84 (95% CI, 0.42-1.25 kcal/kg per day; P<.001) and 0.69 (95% CI, 0.25-1.12 kcal/kg day; P = .002) for activity, and 0.77 (95% CI, 0.18-1.36 mL/kg per minute; P = .01) and 1.34 (95% CI, 0.72-1.96 mL/kg per minute; P<.001) for VO2peak for the lifestyle and structured activity groups, respectively. There were significant and comparable reductions in systolic blood pressure (-3.63 [95% CI, -5.54 to -1.72 mm Hg; P<.001] and -3.26 [95% CI, -5.26 to -1.25 mm Hg; P = .002]) and diastolic blood pressure (-5.38 [95% CI, -6.90 to -3.86 mm Hg; P<.001] and -5.14 [95% CI, -6.73 to -3.54 mm Hg; P<.001) for the lifestyle and structured activity groups, respectively. Neither group significantly changed their weight (-0.05 [95% CI, -1.05 to 0.96 kg; P = .93] and 0.69 [95% CI, -0.37 to 1.74 kg; P = .20]), but each group significantly reduced their percentage of body fat (-2.39% [95% CI, -2.92% to -1.85%; P<.001] and -1.85% [95% CI, -2.41 % to -1.28%; P<.001]) in the lifestyle and structured activity groups, respectively. In previously sedentary healthy adults, a lifestyle physical activity intervention is as effective as a structured exercise program in improving physical activity, cardiorespiratory fitness, and blood pressure.
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              Internal pilot studies for estimating sample size.

              We develop the idea of using data from the first 'few' patients entered in a clinical trial to estimate the final trial size needed to have specified power for rejecting H0 in favour of H1 if a real difference exists. When comparing means derived from Normally distributed data, there is no important effect on test size, power or expected trial size, provided that a minimum of about 20 degrees of freedom are used to estimate residual variance. Relative advantages and disadvantages of using larger internal pilot studies are presented. These revolve around crude expectations of the final study size, recruitment rate, duration of follow-up and practical constraints on the ability to prevent the circulation of unblinded randomization codes to investigators and those involved in editing and checking data.
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                Author and article information

                Journal
                BMC Public Health
                BMC Public Health
                BioMed Central
                1471-2458
                2011
                23 February 2011
                : 11
                : 129
                Affiliations
                [1 ]Centre for Sport and Exercise Science, Faculty of Health and Well-being, Sheffield Hallam University, Collegiate Crescent Campus, Sheffield, S10 2BP, UK
                [2 ]Clinical Trials Research Unit, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK
                [3 ]School of Health and Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK
                Article
                1471-2458-11-129
                10.1186/1471-2458-11-129
                3050753
                21345182
                97a607ba-1381-491c-9e2d-4afad7ca80f5
                Copyright ©2011 Scott et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 28 July 2010
                : 23 February 2011
                Categories
                Research Article

                Public health
                Public health

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