The Lifestyle Intervention for the Treatment of Diabetes study (LIFT Diabetes): Design and baseline characteristics for a randomized translational trial to improve control of cardiovascular disease risk factors.

Abstract:

:The prevalence of type 2 diabetes continues to increase in minority and underserved patients, who are also more likely to have poorer control of diabetes and related risk factors for complications. Although the Look AHEAD trial has demonstrated improved risk factor control among overweight or obese diabetes patients who received an intensive lifestyle intervention, translating such findings into accessible programs is a major public health challenge. The purpose of this paper is to report the design and baseline characteristics of the Lifestyle Interventions for the Treatment of Diabetes study (LIFT Diabetes). The overall goal is to test the impact of a community-based lifestyle weight loss (LWL) intervention adapted from Look AHEAD on cardiovascular disease risk at 12-months and 24-months among minority and lower income diabetes patients. Secondary outcomes include body weight, physical activity, medication use, cost, resource utilization, and safety. The primary hypothesis being tested is that the LWL will result in 10% relative reduction in CVD risk compared to the DSM. We have randomized 260 overweight or obese adults with diabetes one of two 12-month interventions: a LWL condition delivered by community health workers or a diabetes self-management (DSM) education condition. The baseline demographic characteristics indicate that our sample is predominantly female, obese, low income, and ethnic minority. Translating evidence-based, lifestyle strategies, and targeting minority and underserved patients, will yield, if successful, a model for addressing the burden of diabetes and may favorably impact health disparities.

journal_name

Contemp Clin Trials

authors

Katula JA,Kirk JK,Pedley CF,Savoca MR,Effoe VS,Bell RA,Bertoni AG,LIFT Diabetes Team.

doi

10.1016/j.cct.2016.12.005

subject

Has Abstract

pub_date

2017-02-01 00:00:00

pages

89-99

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(16)30464-5

journal_volume

53

pub_type

杂志文章,随机对照试验
  • Weight management in rural health clinics: The Midwest diet and exercise trial.

    abstract::Obesity prevalence is higher in rural compared to urban residents. Rural health clinics offer a potential venue for delivery of weight management. However, traditional programs require travel to attend on-site meetings which is impractical or inconvenient for rural residents. Clinic staff in most rural settings are un...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2018.02.006

    authors: Gorczyca AM,Washburn RA,Ptomey L,Mayo MS,Sullivan DK,Gibson CA,Lee R,Stolte S,Donnelly JE

    更新日期:2018-04-01 00:00:00

  • Design and protocol of a randomized multiple behavior change trial: Make Better Choices 2 (MBC2).

    abstract:BACKGROUND:Suboptimal diet and inactive lifestyle are among the most prevalent preventable causes of premature death. Interventions that target multiple behaviors are potentially efficient; however the optimal way to initiate and maintain multiple health behavior changes is unknown. OBJECTIVE:The Make Better Choices 2...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.01.009

    authors: Pellegrini CA,Steglitz J,Johnston W,Warnick J,Adams T,McFadden HG,Siddique J,Hedeker D,Spring B

    更新日期:2015-03-01 00:00:00

  • Clinical trial literacy among injecting drug users in Sydney, Australia: A pilot study.

    abstract::This pilot study examined knowledge, understanding and perceived acceptability of key methodological concepts in clinical trials among injecting drug users (IDUs) in Sydney, Australia. Participants were clinical trial-experienced (n = 17) and trial-naïve (n = 99) IDUs recruited from community needle and syringe progra...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2009.04.002

    authors: Doab A,Topp L,Day CA,Dore GJ,Maher L

    更新日期:2009-09-01 00:00:00

  • Care partner problem solving training (CP-PST) for care partners of adults with traumatic brain injury during inpatient rehabilitation: Study protocol for a multisite, randomized, single-blind clinical feasibility trial.

    abstract::Traumatic brain injury (TBI) often leads to immediate and chronic functional impairments that affect care partners, or those providing physical and/or emotional support to individuals with TBI. The many challenges associated with being a care partner often lead to caregiver burden and can compromise the well-being and...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2019.03.004

    authors: Juengst SB,Silva V,Goldin Y,Cicerone K,Lengenfelder J,Chiaravalloti N,Driver S,Mellick D,Dart G,Kew CL,Nabasny A,Bell KR

    更新日期:2019-05-01 00:00:00

  • Designing a randomized controlled trial to evaluate a community-based narrative intervention for improving colorectal cancer screening for African Americans.

    abstract:OBJECTIVE:To describe the methodology of a 2-arm randomized controlled trial that compared the effects of a narrative and didactic version of the Witness CARES (Community Awareness, Reach, & Empowerment for Screening) intervention on colorectal cancer screening behavior among African Americans, as well as the cognitive...

    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.2017.11.019

    authors: Ellis EM,Erwin DO,Jandorf L,Saad-Harfouche F,Sriphanlop P,Clark N,Dauphin C,Johnson D,Klasko-Foster LB,Martinez C,Sly J,White D,Winkel G,Kiviniemi MT

    更新日期:2018-02-01 00:00:00

  • Use of deception to achieve double-blinding in a clinical trial of Melaleuca alternifolia (tea tree) oil for the treatment of recurrent herpes labialis.

    abstract::Double-blinding is an important and widely implemented feature of clinical trials although its success is rarely assessed. In a randomized, placebo-controlled trial of tea tree oil, an aromatic essential oil, for the treatment of recurrent herpes labialis (RHL), or cold sores, deception was used to prevent volunteers ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2007.04.006

    authors: Carson CF,Smith DW,Lampacher GJ,Riley TV

    更新日期:2008-01-01 00:00:00

  • Evaluation of operational chronic infection endpoints for HCV vaccine trials.

    abstract::Hepatitis C virus (HCV) is a leading cause of chronic liver disease. The natural history of HCV infection is heterogeneous, and a person infected with HCV can clear the virus or progress to a chronic infection. The chronic infection can remain asymptomatic for decades before the development of liver cirrhosis and/or c...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2008.03.006

    authors: Kang M,Nicolay U

    更新日期:2008-09-01 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

  • Evaluating the treatment of obstructive sleep apnea comorbid with insomnia disorder using an incomplete factorial design.

    abstract::Chronic insomnia disorder is a prevalent condition and a significant proportion of these individuals also have obstructive sleep apnea (OSA). These two sleep disorders have distinct pathophysiology and are managed with different treatment approaches. High comorbidity rates have been a catalyst for emerging studies exa...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.12.017

    authors: Crawford MR,Turner AD,Wyatt JK,Fogg LF,Ong JC

    更新日期:2016-03-01 00:00:00

  • Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

    abstract:BACKGROUND:Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2013.02.011

    authors: Gaus W,Muche R

    更新日期:2013-05-01 00:00:00

  • Dose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease in adults: study rationale, design and methods.

    abstract::Although progress has been made to elucidate the effects of exercise as a strategy for reducing obesity and related cardiometabolic risk factors, the specific exercise exposures required to achieve optimal benefit continue to be the source of considerable uncertainty and debate. Despite the inference of a dose-depende...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.10.010

    authors: Ross R,Hudson R,Day AG,Lam M

    更新日期:2013-01-01 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

  • Efficacy of a smoking quit line in the military: baseline design and analysis.

    abstract::Thirty percent of all military personnel smoke cigarettes. Because of the negative health consequences and their impact on physical fitness, overall health, and military readiness, the Department of Defense has identified the reduction of tobacco use as a priority of US military forces. This study aims to evaluate the...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.04.009

    authors: Richey PA,Klesges RC,Talcott GW,Debon M,Womack C,Thomas F,Hryshko-Mullen A

    更新日期:2012-09-01 00:00:00

  • A randomized controlled trial of the efficacy and cost-effectiveness of a brief intensified cognitive behavioral therapy and/or pharmacotherapy for mood and anxiety disorders: design and methods.

    abstract:BACKGROUND:Anxiety and mood disorders involve a high disease burden and are associated with high economic costs. A stepped-care approach intervention and abbreviated diagnostic method are assumed to increase effectiveness and efficiency of the mental healthcare and are expected to reduce economic costs. METHODS:Presen...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.05.002

    authors: Meuldijk D,Carlier IV,van Vliet IM,van den Akker-Marle ME,Zitman FG

    更新日期:2012-09-01 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

  • 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

  • Design and rationale of the STRIVE trial to improve cardiometabolic health among children and families.

    abstract:BACKGROUND:Many of the health behaviors known to contribute to cardiometabolic risk and disease (CMRD), including physical activity, diet, sleep, and screen time, begin during childhood. Given the population-wide burden of CMRD, novel ways of assessing risk and providing feedback to support behavior change are needed. ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.07.012

    authors: Oreskovic NM,Fletcher R,Sharifi M,Knutsen JD,Chilingirian A,Taveras EM

    更新日期:2016-07-01 00:00:00

  • A web-based personalized risk communication and decision-making tool for women with dense breasts: Design and methods of a randomized controlled trial within an integrated health care system.

    abstract:BACKGROUND:Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk coun...

    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.2017.02.009

    authors: Knerr S,Wernli KJ,Leppig K,Ehrlich K,Graham AL,Farrell D,Evans C,Luta G,Schwartz MD,O'Neill SC

    更新日期:2017-05-01 00:00:00

  • 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 en...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2008.03.005

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

    更新日期:2008-09-01 00:00:00

  • Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.

    abstract::We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol...

    journal_title:Contemporary clinical trials

    pub_type: 更正并重新发布的文章,已发布勘误

    doi:10.1016/j.cct.2020.106128

    authors: Vaca FE,Dziura J,Abujarad F,Pantalon MV,Hsiao A,Field CA,D'Onofrio G

    更新日期:2020-10-01 00:00:00

  • A comparison of methods and results in recruiting white and black women into reproductive studies: the MMC-PSU cooperative center on reproduction experience.

    abstract::Establishing a holistic approach for the enrollment of subjects into clinical trials that includes strategies for the recruitment of non-traditional and minority populations has been an elusive task. The existence of such a design, that is understood and embraced by investigators and the target communities, would stre...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2007.11.003

    authors: Sweet S,Legro RS,Coney P

    更新日期:2008-07-01 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

  • Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi.

    abstract:BACKGROUND:Persons with chronic obstructive pulmonary disease (COPD) have reduced exercise capacity and levels of physical activity. Supervised, facility-based pulmonary rehabilitation programs improve exercise capacity and reduce dyspnea, but novel long-term strategies are needed to maintain the benefits gained. Mind-...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.09.004

    authors: Moy ML,Wayne PM,Litrownik D,Beach D,Klings ES,Davis RB,Yeh GY

    更新日期:2015-11-01 00:00:00

  • Impact of aerobic exercise training during chemotherapy on cancer related cognitive impairments in patients suffering from acute myeloid leukemia or myelodysplastic syndrome - Study protocol of a randomized placebo-controlled trial.

    abstract::Cancer related cognitive impairments (CRCI) are frequently reported by patients prior to, during and after medical treatment. Although this cognitive decline severely affects patients' quality of life, little is known about effective treatments. Exercise programs represent a promising supportive strategy in this field...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.05.007

    authors: Zimmer P,Oberste M,Bloch W,Schenk A,Joisten N,Hartig P,Wolf F,Baumann FT,Garthe A,Hallek M,Elter T

    更新日期:2016-07-01 00:00:00

  • Are current standards of reporting quality for clinical trials sufficient in addressing important sources of bias?

    abstract::Determining the quality of a randomized clinical trial (RCT) is necessary for decision-makers to determine the believability and applicability of the trial findings. Issues that are likely to affect the utility of RCT evidence include issues of bias, random error and applicability. In this article we focus primarily o...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,评审

    doi:10.1016/j.cct.2015.07.019

    authors: Mills EJ,Ayers D,Chou R,Thorlund K

    更新日期:2015-11-01 00:00:00

  • Does outpatient palliative care improve patient-centered outcomes in Parkinson's disease: Rationale, design, and implementation of a pragmatic comparative effectiveness trial.

    abstract::Patients with Parkinson's disease and related disorders (PDRD) and their families have considerable unmet needs including non-motor symptom management, caregiver support, spiritual wellbeing, advance care planning, and end-of-life care. There is increasing interest in applying palliative care (PC) models to better mee...

    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.2019.02.005

    authors: Kluger BM,Katz M,Galifianakis N,Pantilat SZ,Kutner JS,Sillau S,Gritz M,Jones J,Fairclough D,Sumrall M,Hall K,Miyasaki J

    更新日期:2019-04-01 00:00:00

  • The feasibility and acceptability of a diet and exercise trial in overweight and obese black breast cancer survivors: The Stepping STONE study.

    abstract:PURPOSE:Black breast cancer survivors have high rates of obesity and low physical activity levels. Little is known about the acceptability and feasibility of interventions in this population. OBJECTIVE:A two-arm RCT was launched to assess the efficacy of a culturally targeted 12-week multimodal lifestyle intervention ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.12.005

    authors: Sheppard VB,Hicks J,Makambi K,Hurtado-de-Mendoza A,Demark-Wahnefried W,Adams-Campbell L

    更新日期:2016-01-01 00:00:00

  • The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement.

    abstract::If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2005.02.008

    authors: Mills EJ,Wu P,Gagnier J,Devereaux PJ

    更新日期:2005-08-01 00:00:00

  • Participation in pediatric epidemiologic research: the SEARCH for Diabetes in Youth Study experience.

    abstract:BACKGROUND:We evaluated the association of demographic and clinical characteristics with participation in an epidemiologic study of diabetes mellitus among youth. METHODS:SEARCH for Diabetes in Youth is a multicenter study of physician-diagnosed diabetes in youth under the age of 20 comprising a surveillance and a coh...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.cct.2008.05.008

    authors: Liese AD,Liu L,Davis C,Standiford D,Waitzfelder B,Dabelea D,Bell R,Williams D,Imperatore G,Lawrence JM

    更新日期:2008-11-01 00:00:00

  • Design of a large outcome trial for a multivalent human papillomavirus L1 virus-like particle vaccine.

    abstract:BACKGROUND:The 9-valent human papillomavirus (HPV) (9vHPV) vaccine targets the four HPV types (6/11/16/18) covered by the licensed quadrivalent HPV (qHPV) vaccine and five additional types (31/33/45/52/58). A large outcome trial of 9vHPV vaccine was conducted. METHODS:An active control (qHPV vaccine) was used because ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.cct.2015.02.009

    authors: Luxembourg A,Bautista O,Moeller E,Ritter M,Chen J

    更新日期:2015-05-01 00:00:00