Design of a pragmatic cluster randomised controlled trial: ecological approach to increasing physical activity in an urban community.

Abstract:

:This study was set up to test an ecological intervention using a pragmatic cluster randomised controlled design (RCT) aimed at increasing physical activity (PA) within the community in a deprived inner-city area in the UK. The research will provide a detailed mapping (using Graphical Information Systems GIS) of the environment at lower super output area (SOA) level in Stoke-on-Trent (SoT) and will evaluate the relationship between the environment, PA behaviour, health and healthcare utilisation. The environmental mapping will aggregate data from a wide range of available databases, augmented by local data gathering and validation, to produce a comprehensive geo-coded map of 10 SOAs (covering a population ~15,000). GIS will be used to derive indices through which to evaluate the relationship between environmental characteristics and levels of physical activity and health, using Hierarchical Linear Modelling (HLM). Environmental indices used will include: proximity of PA spaces and facilities, street connectivity, land use mix, population density, mass transport provision, traffic, safety, crime, proximity of food outlets and shops, "Walkability Index", weather and indices of multiple deprivation (IMD). The areas for mapping, baseline assessment and intervention will be considered in two parts, a) community-based and b) schools-based. The effectiveness of the community-based intervention will be assessed by an independent panel survey conducted at baseline and at 2 years follow-up, with an expected 10% increase in the proportion of the population more active in the intervention arm. Effectiveness of the schools-based intervention will be designed to detect an increase of ~15 min/day in school children's moderate to vigorous PA (MVPA). Resource use, cost, willingness to pay and incidental consequences data will be collected alongside the community-based intervention to enable economic modelling from health and social care, societal, other public service and participant perspectives. Findings from the project will inform public policy for increasing population PA and improving neighbourhoods and urban design.

journal_name

Contemp Clin Trials

authors

Davey RC,Cochrane T,Gidlow C,Fairburn J,Smith G

doi

10.1016/j.cct.2008.03.005

subject

Has Abstract

pub_date

2008-09-01 00:00:00

pages

774-82

issue

5

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(08)00033-5

journal_volume

29

pub_type

杂志文章
  • The SHED-IT weight loss maintenance trial protocol: A randomised controlled trial of a weight loss maintenance program for overweight and obese men.

    abstract:UNLABELLED:Despite short-term efficacy, many weight loss studies demonstrate poor long-term results and have difficulty recruiting men. Cost-effective treatments that help men achieve long-term weight loss are required. Using a two-phase, assessor-blinded, parallel-group randomised controlled trial design this study wi...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.11.004

    authors: Young MD,Collins CE,Callister R,Plotnikoff RC,Doran CM,Morgan PJ

    更新日期:2014-01-01 00:00:00

  • PREFER study: a randomized clinical trial testing treatment preference and two dietary options in behavioral weight management--rationale, design and baseline characteristics.

    abstract:BACKGROUND:Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach t...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2005.08.002

    authors: Burke LE,Choo J,Music E,Warziski M,Styn MA,Kim Y,Sevick MA

    更新日期:2006-02-01 00:00:00

  • Can lifestyle modification improve neurocognition? Rationale and design of the ENLIGHTEN clinical trial.

    abstract:BACKGROUND:Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and die...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2012.09.004

    authors: Blumenthal JA,Smith PJ,Welsh-Bohmer K,Babyak MA,Browndyke J,Lin PH,Doraiswamy PM,Burke J,Kraus W,Hinderliter A,Sherwood A

    更新日期:2013-01-01 00:00:00

  • Rationale and design of a trial on the role of bosentan in Fontan patients: improvement of exercise capacity?

    abstract:BACKGROUND:The Fontan circulation is a palliative procedure performed in patients with complex congenital heart disease (CHD), making transpulmonary blood flow dependent on the systemic venous pressure. In a Fontan circulation a low pulmonary vascular resistance (PVR) is crucial, as is epitomized by the observation tha...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2011.04.001

    authors: Schuuring MJ,Vis JC,Bouma BJ,van Dijk AP,van Melle JP,Pieper PG,Vliegen HW,Sieswerda GT,Mulder BJ

    更新日期:2011-07-01 00:00:00

  • Design and methods of the Gentle Cardiac Rehabilitation Study--A behavioral study of tai chi exercise for patients not attending cardiac rehabilitation.

    abstract:INTRODUCTION:Cardiac rehabilitation (CR) programs reduce overall and cardiovascular mortality in patients with a history of acute coronary events or revascularization procedures, but only 30% of patients enroll in CR and attrition rates reach up to 60%. Tai chi, a mind-body practice based on light/moderate aerobic exer...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.06.020

    authors: Salmoirago-Blotcher E,Wayne P,Bock BC,Dunsiger S,Wu WC,Stabile L,Yeh G

    更新日期:2015-07-01 00:00:00

  • The Mexican-American Trial of Community Health workers (MATCH): design and baseline characteristics of a randomized controlled trial testing a culturally tailored community diabetes self-management intervention.

    abstract:OBJECTIVES:Community Health Workers (CHWs) have been recommended to reduce diabetes disparities, but few robust trials of this approach have been conducted. Limitations of prior studies include: unspecified a priori outcomes; lack of blinded outcome assessments; high participant attrition rates; and lack of attention t...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2011.10.013

    authors: Rothschild SK,Martin MA,Swider SM,Lynas CT,Avery EF,Janssen I,Powell LH

    更新日期:2012-03-01 00:00:00

  • An analysis of U.S. practices of paying research participants.

    abstract:BACKGROUND:Despite controversy about paying research subjects, little is known about actual practices in the U.S., including what type of studies offer payment, to what type of subjects, and how amounts are determined. OBJECTIVE:To document current U.S. practices regarding payment to research subjects. METHODS:The pr...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2005.02.003

    authors: Grady C,Dickert N,Jawetz T,Gensler G,Emanuel E

    更新日期:2005-06-01 00:00:00

  • Statistical evaluation of HIV vaccines in early clinical trials.

    abstract::The HIV pandemic is a pressing threat to global public health; HIV vaccine development is critical. Clinical evaluation of HIV vaccine candidates differs from the standard therapeutics trial framework primarily due to the fact that healthy individuals are studied. We present an early stage evaluation program developed...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2005.11.008

    authors: Moodie Z,Rossini AJ,Hudgens MG,Gilbert PB,Self SG,Russell ND

    更新日期:2006-04-01 00:00:00

  • A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol.

    abstract:BACKGROUND:Chronic Obstructive Pulmonary Disease (COPD) frequently coexists with other diseases. Whereas COPD action plans are currently part of usual care, they are less suitable and potentially unsafe for use in the presence of comorbidities. This study evaluates whether an innovative treatment approach directed towa...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2013.06.003

    authors: Lenferink A,Frith P,van der Valk P,Buckman J,Sladek R,Cafarella P,van der Palen J,Effing T

    更新日期:2013-09-01 00:00:00

  • Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.

    abstract::Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as co...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2020.106159

    authors: Fillingim RB,Woods AJ,Ahn H,Wu SS,Redden DT,Lai S,Deshpande H,Deutsch G,Sibille KT,Staud R,Zeidan F,Goodin BR

    更新日期:2020-11-01 00:00:00

  • Evaluation of the ability of clinical research participants to comprehend informed consent form.

    abstract:BACKGROUND:The comprehension of informed consent is an integral part of clinical trials. Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials. METHODS:Patients who were invited to particip...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.cct.2009.03.005

    authors: Bhansali S,Shafiq N,Malhotra S,Pandhi P,Singh I,Venkateshan SP,Siddhu S,Sharma YP,Talwar KK

    更新日期:2009-09-01 00:00:00

  • A pragmatic randomized comparative effectiveness trial of transitional care for a socioeconomically diverse population: Design, rationale and baseline characteristics.

    abstract::Transitional care programs have been widely used to reduce readmissions and improve the quality and safety of the handoff process between hospital and outpatient providers. Very little is known about effective transitional care interventions among patients who are uninsured or with Medicaid. This paper describes the d...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2017.12.003

    authors: Schaeffer C,Teter C,Finch EA,Hurt C,Keeter MK,Liss DT,Rogers A,Sheth A,Ackermann R

    更新日期:2018-02-01 00:00:00

  • A randomized controlled trial of a trauma-informed school prevention program for urban youth: Rationale, design, and methods.

    abstract:INTRODUCTION:Youth in disadvantaged urban areas are frequently exposed to chronic stress and trauma, including housing instability, neighborhood violence, and other poverty-related adversities. These exposures increase risk for emotional, behavioral, and academic problems and ultimately, school dropout. Schools are a p...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2019.105895

    authors: Mendelson T,Clary LK,Sibinga E,Tandon D,Musci R,Mmari K,Salkever D,Stuart EA,Ialongo N

    更新日期:2020-03-01 00:00:00

  • A novel diagram and complement to the CONSORT chart for presenting multimodal clinical trials.

    abstract::We developed a novel diagram to depict patient flow and outcomes in clinical trials. In contrast to flow diagrams such as the CONSORT chart, our diagram enables individual patient histories to be traced and depicts important patterns of treatment administration and outcomes, such as response and adverse events. Also, ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2009.01.010

    authors: Schuller JC,Mayer M,Lanz D,Schmitz SF,Brauchli P,Leupin N

    更新日期:2009-05-01 00:00:00

  • Concordance of Medicaid and pharmacy record data in inner-city children with asthma.

    abstract:BACKGROUND:Management of asthma involves adherence to medication regimens. Assessing adherence is difficult for health care providers and researchers. Self-reported medication use is subjective, so objective methods of data collection for medication use are frequently used in asthma research. The aim of this project is...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2007.05.002

    authors: Mudd KE,Bollinger ME,Hsu VD,Manning A,Tsoukleris MG,Butz AM

    更新日期:2008-01-01 00:00:00

  • Comparative effectiveness of next generation genomic sequencing for disease diagnosis: design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes.

    abstract::Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effect...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2014.06.016

    authors: Gallego CJ,Bennette CS,Heagerty P,Comstock B,Horike-Pyne M,Hisama F,Amendola LM,Bennett RL,Dorschner MO,Tarczy-Hornoch P,Grady WM,Fullerton SM,Trinidad SB,Regier DA,Nickerson DA,Burke W,Patrick DL,Jarvik GP,Veenstra D

    更新日期:2014-09-01 00:00:00

  • Family Access to a Dentist Study (FADS): A multi-center randomized controlled trial.

    abstract:INTRODUCTION:Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aim...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2015.10.006

    authors: Nelson S,Riedy C,Albert JM,Lee W,Slusar MB,Curtan S,Ferretti G,Cunha-Cruz J,Milgrom P

    更新日期:2015-11-01 00:00:00

  • Mindfulness-based relapse prevention combined with virtual reality cue exposure for methamphetamine use disorder: Study protocol for a randomized controlled trial.

    abstract:BACKGROUND:Mindfulness-based relapse prevention (MBRP) is a method that combines cognitive behavioral relapse prevention with mindfulness practice. Research suggests that MBRP can effectively reduce withdrawal/craving in people with substance use disorder (SUD). An important part of MBRP is to practice mindfulness medi...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2018.04.006

    authors: Chen XJ,Wang DM,Zhou LD,Winkler M,Pauli P,Sui N,Li YH

    更新日期:2018-07-01 00:00:00

  • Expansion of the modified Zelen's approach randomization and dynamic randomization with partial block supplies at the centers to unequal allocation.

    abstract::Modified Zelen's approach is a randomization technique useful in multi-center trials where balance in treatment assignments within a center is desired. It has great balancing properties in a study with equal allocation to several treatment arms. This technique can also be used in studies with unequal allocation, where...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,评审

    doi:10.1016/j.cct.2011.08.006

    authors: Kuznetsova OM,Tymofyeyev Y

    更新日期:2011-11-01 00:00:00

  • Motivating first-time, group O blood donors to return: Rationale and design of a randomized controlled trial of a post-donation telephone interview.

    abstract::First-time blood donors are essential to the US donor pool, providing nearly a third of all donations. Unfortunately, there are a wide variety of obstacles to repeat donation and new donors are extremely difficult to retain. Because each donor experiences a unique set of deterrents, we developed a post-donation interv...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2015.07.020

    authors: France JL,France CR,Carlson BW,Kessler DA,Rebosa M,Shaz BH,Madden K,Carey PM

    更新日期:2015-09-01 00:00:00

  • Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

    abstract::Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2014.01.001

    authors: Logvinov I

    更新日期:2014-03-01 00:00:00

  • Can weight loss improve migraine headaches in obese women? Rationale and design of the Women's Health and Migraine (WHAM) randomized controlled trial.

    abstract:BACKGROUND:Research demonstrates a link between migraine and obesity. Obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women. These findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.03.004

    authors: Bond DS,O'Leary KC,Thomas JG,Lipton RB,Papandonatos GD,Roth J,Rathier L,Daniello R,Wing RR

    更新日期:2013-05-01 00:00:00

  • Recruitment strategies for a lung cancer chemoprevention trial involving ex-smokers.

    abstract::The ability to recruit qualified subjects who are willing to adhere to the study protocol in clinical trials is an essential component of translational research. Such tasks can be particularly challenging for chemoprevention studies when the targeted study population is healthy, at risk individuals who do not have sig...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2009.05.004

    authors: Kye SH,Tashkin DP,Roth MD,Adams B,Nie WX,Mao JT

    更新日期:2009-09-01 00:00:00

  • Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and objectives.

    abstract:BACKGROUND:Despite significant advancements in psychopharmacology, treating major depressive disorder (MDD) is still a challenge considering the efficacy, tolerability, safety, and economical costs of most antidepressant drugs. One approach that has been increasingly investigated is modulation of cortical activity with...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2010.09.007

    authors: Brunoni AR,Valiengo L,Baccaro A,Zanao TA,de Oliveira JF,Vieira GP,Bueno VF,Goulart AC,Boggio PS,Lotufo PA,Bensenor IM,Fregni F

    更新日期:2011-01-01 00:00:00

  • Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study.

    abstract:BACKGROUND:Despite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2020.106008

    authors: Rosen CS,Davis CA,Riggs D,Cook J,Peterson AL,Young-McCaughan S,Comtois KA,Haddock CK,Borah EV,Dondanville KA,Finley EP,Jahnke SA,Poston WSC,Wiltsey-Stirman S,Neitzer A,Broussard CR,Brzuchalski MA,Clayton MSP,Conforte

    更新日期:2020-06-01 00:00:00

  • The use of minimization in clinical trials.

    abstract::Since its introduction in 1974 the use of the term Minimization has been broadened to include other algorithms. All algorithms use patient characteristics to determine the assignment that produces the best overall balance between treatment groups. They differ in whether or not they use all of the data from each previo...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,meta分析,评审

    doi:10.1016/j.cct.2009.12.005

    authors: Taves DR

    更新日期:2010-03-01 00:00:00

  • Variability of the glycemic response to single food products in healthy subjects.

    abstract:BACKGROUND:Many studies on the health effects of the glycemic index (GI) are confounded by differences in the intakes of other macronutrients and fibre. Little data exist about the within- and between-subject variability of the GI. OBJECTIVE:Our objectives were therefore (i) to calculate the GI of eight commonly used ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2009.08.001

    authors: Vrolix R,Mensink RP

    更新日期:2010-01-01 00:00:00

  • Optimal treatment for women with a persisting pregnancy of unknown location, a randomized controlled trial: The ACT-or-NOT trial.

    abstract:OBJECTIVE:Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, includin...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2018.09.009

    authors: Barnhart KT,Sammel MD,Stephenson M,Robins J,Hansen KR,Youssef WA,Santoro N,Eisenberg E,Zhang H,NICHD Cooperative Reproductive Medicine Network.

    更新日期:2018-10-01 00:00:00

  • Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart and Tamsulosin) trial rationale and study design.

    abstract::Benign prostatic hyperplasia (BPH) is a highly prevalent condition in aging men, which can be progressive and lead to acute urinary retention (AUR) and the need for surgery. It is commonly treated with alpha-blockers and 5alpha-reductase inhibitors (5ARIs), both of which improve the symptoms of BPH. Long-term treatmen...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2007.07.008

    authors: Siami P,Roehrborn CG,Barkin J,Damiao R,Wyczolkowski M,Duggan A,Major-Walker K,Morrill BB,CombAT study group.

    更新日期:2007-11-01 00:00:00

  • Functional Dyspepsia Treatment Trial (FDTT): a double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics.

    abstract:BACKGROUND:Functional dyspepsia (FD) is a common problem affecting up to 10-25% of individuals. FD accounts for significant health care costs and affects quality of life but has no definitive treatment. OBJECTIVES:The Functional Dyspepsia Treatment Trial (FDTT) aims to test whether treatment with an antidepressant (am...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.02.002

    authors: Talley NJ,Locke GR 3rd,Herrick LM,Silvernail VM,Prather CM,Lacy BE,DiBaise JK,Howden CW,Brenner DM,Bouras EP,El-Serag HB,Abraham BP,Moayyedi P,Zinsmeister AR

    更新日期:2012-05-01 00:00:00