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. PURPOSE:This paper describes the design and rationale for the Study for using Technology to Reach Individual Excellence (STRIVE), a randomized controlled trial testing the use of an integrated, closed-loop feedback system that incorporates longitudinal, patient-generated, mobile health technology (mHealth) data on health behaviors and provides clinical recommendations to help manage CMRD among at-risk families. METHODS:STRIVE is a 6-month trial among 68 children, ages 6-12year olds with a body mass index≥85th percentile from Massachusetts with at least one parent with CMRD. Data on several health behaviors will be collected daily over 6months. Children and parents will each wear wristbands that collect objective physical activity, sleep, and screen time data via accelerometry, noise, and infrared detection. Sugar sweetened beverage consumption will be assessed by self-report via a smartphone application. Weight will be collected using a wireless scale. Intervention group parents receive feedback on their child's health behaviors and personalized CMRD counseling via mobile messaging. Control parents receive standard of care recommendations and weekly health behavior reports for self-guided care. CONCLUSION:The STRIVE trial will test the use of mHealth and closed-loop feedback systems to improve health behaviors among families at-risk for or with established CMRD.

journal_name

Contemp Clin Trials

authors

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

doi

10.1016/j.cct.2016.07.012

subject

Has Abstract

pub_date

2016-07-01 00:00:00

pages

149-54

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(16)30117-3

journal_volume

49

pub_type

杂志文章,随机对照试验
  • Simple efficient bias corrected instrumental variable estimator for randomized trials with noncompliance.

    abstract::An instrumental variable (IV) estimator has been widely used to estimate causal effects among compliers in randomized trials with noncompliance. The estimator of complier average treatment effect can be expressed as a ratio of two unbiased estimators but the ratio estimator is not unbiased. The bias of IV estimator ca...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2012.03.013

    authors: Chan KC

    更新日期:2012-07-01 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

  • Bayes factor and posterior probability: Complementary statistical evidence to p-value.

    abstract::As a convention, a p-value is often computed in hypothesis testing and compared with the nominal level of 0.05 to determine whether to reject the null hypothesis. Although the smaller the p-value, the more significant the statistical test, it is difficult to perceive the p-value in a probability scale and quantify it ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2015.07.001

    authors: Lin R,Yin G

    更新日期:2015-09-01 00:00:00

  • Can atorvastatin with metformin change the natural history of prostate cancer as characterized by molecular, metabolomic, imaging and pathological variables? A randomized controlled trial protocol.

    abstract:BACKGROUND:Atorvastatin and metformin are known energy restricting mimetic agents that act synergistically to produce molecular and metabolic changes in advanced prostate cancer (PCa). This trial seeks to determine whether these drugs favourably alter selected parameters in men with clinically-localized, aggressive PCa...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.06.014

    authors: Roberts MJ,Yaxley JW,Coughlin GD,Gianduzzo TR,Esler RC,Dunglison NT,Chambers SK,Medcraft RJ,Chow CW,Schirra HJ,Richards RS,Kienzle N,Lu M,Brereton I,Samaratunga H,Perry-Keene J,Payton D,Oyama C,Doi SA,Lavin MF,Gar

    更新日期:2016-09-01 00:00:00

  • Neurodevelopment of children exposed to anesthesia: design of the Mayo Anesthesia Safety in Kids (MASK) study.

    abstract::There is increasing evidence that exposure of developing brains in animals, including nonhuman primates, to commonly-utilized anesthetic agents may cause adverse effects on cognition and behavior. In this paper, we summarize our methodology for a population-based, propensity-matched study to evaluate possible anesthes...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2014.12.020

    authors: Gleich SJ,Flick R,Hu D,Zaccariello MJ,Colligan RC,Katusic SK,Schroeder DR,Hanson A,Buenvenida S,Wilder RT,Sprung J,Voigt RG,Paule MG,Chelonis JJ,Warner DO

    更新日期:2015-03-01 00:00:00

  • Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Rationale, design, and methods of a randomized, controlled trial of vitamin C supplementation in pregnancy for the primary prevention of effects of in utero tobacco

    abstract::Despite strong anti-smoking efforts, at least 12% of American women cannot quit smoking when pregnant resulting in >450,000 smoke-exposed infants born yearly. Smoking during pregnancy is the largest preventable cause of childhood respiratory illness including wheezing and asthma. Recent studies have shown a protective...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2017.05.008

    authors: McEvoy CT,Milner KF,Scherman AJ,Schilling DG,Tiller CJ,Vuylsteke B,Shorey-Kendrick LE,Spindel ER,Schuff R,Mitchell J,Peters D,Metz J,Haas D,Jackson K,Tepper RS,Morris CD

    更新日期:2017-07-01 00:00:00

  • Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors.

    abstract:BACKGROUND:Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these d...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.08.014

    authors: Cases MG,Frugé AD,De Los Santos JF,Locher JL,Cantor AB,Smith KP,Glover TA,Cohen HJ,Daniel M,Morrow CD,Moellering DR,Demark-Wahnefried W

    更新日期:2016-09-01 00:00:00

  • DIETFITS study (diet intervention examining the factors interacting with treatment success) - Study design and methods.

    abstract::Numerous studies have attempted to identify successful dietary strategies for weight loss, and many have focused on Low-Fat vs. Low-Carbohydrate comparisons. Despite relatively small between-group differences in weight loss found in most previous studies, researchers have consistently observed relatively large between...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2016.12.021

    authors: Stanton MV,Robinson JL,Kirkpatrick SM,Farzinkhou S,Avery EC,Rigdon J,Offringa LC,Trepanowski JF,Hauser ME,Hartle JC,Cherin RJ,King AC,Ioannidis JP,Desai M,Gardner CD

    更新日期:2017-02-01 00:00:00

  • Minority participation in a school-based randomized clinical trial of tooth decay prevention in the United States.

    abstract:PURPOSE:To describe the strategies-based on the social triad concept of a partnership of researchers, school personnel and community-employed to recruit low-income, minority parent/caregivers of kindergarten children into a school-based tooth decay prevention trial in the United States. METHODS:The study site was an u...

    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.2011.09.012

    authors: Nelson S,Milgrom P

    更新日期:2012-01-01 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

  • The HealthyTexts study: a randomized controlled trial to improve skin cancer prevention behaviors among young people.

    abstract::Several randomized trials have found behavior change programs delivered via text messaging to be efficacious to improve preventive health behaviors such as physical activity and stopping smoking; however few have assessed its value in skin cancer prevention or early detection. The HealthyTexts study enrolled 678 parti...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.03.009

    authors: Janda M,Youl P,Marshall AL,Soyer HP,Baade P

    更新日期:2013-05-01 00:00:00

  • The effect of dietary flaxseed on improving symptoms of cardiovascular disease in patients with peripheral artery disease: rationale and design of the FLAX-PAD randomized controlled trial.

    abstract:BACKGROUND:Flaxseed is an important source of alpha-linolenic acid an essential omega-3 fatty acid. The possibility that a supplementation of the diet with foods rich in alpha-linolenic acid, antioxidants and fiber (like flaxseed) has not been investigated. METHODS/DESIGN:The primary objective is to determine whether ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2011.05.005

    authors: Leyva DR,Zahradka P,Ramjiawan B,Guzman R,Aliani M,Pierce GN

    更新日期:2011-09-01 00:00:00

  • Examination of a telephone-based exercise intervention for the prevention of postpartum depression: design, methodology, and baseline data from The Healthy Mom study.

    abstract::Research indicates that exercise is an efficacious intervention for depression among adults; however, little is known regarding its efficacy for preventing postpartum depression. The Healthy Mom study was a randomized controlled trial examining the efficacy of an exercise intervention for the prevention of postpartum ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.07.015

    authors: Lewis BA,Gjerdingen DK,Avery MD,Guo H,Sirard JR,Bonikowske AR,Marcus BH

    更新日期:2012-11-01 00:00:00

  • A two-stage patient enrichment adaptive design in phase II oncology trials.

    abstract::Illustrated is the use of a patient enrichment adaptive design in a randomized phase II trial which allows the evaluation of treatment benefits by the biomarker expression level and makes interim adjustment according to the pre-specified rules. The design was applied to an actual phase II metastatic hepatocellular car...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.12.001

    authors: Song JX

    更新日期:2014-01-01 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

  • Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers.

    abstract::Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve thei...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2017.04.003

    authors: McClure JB,Blasi PR,Cook A,Bush T,Fishman P,Nelson J,Anderson ML,Catz SL

    更新日期:2017-06-01 00:00:00

  • A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction.

    abstract::College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive i...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2020.106089

    authors: Patrick ME,Boatman JA,Morrell N,Wagner AC,Lyden GR,Nahum-Shani I,King CA,Bonar EE,Lee CM,Larimer ME,Vock DM,Almirall D

    更新日期:2020-09-01 00:00:00

  • Design and participant characteristics of a randomized-controlled trial of telemedicine for smoking cessation among rural smokers.

    abstract:INTRODUCTION:In rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiven...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2014.04.008

    authors: Mussulman L,Ellerbeck EF,Cupertino AP,Preacher KJ,Spaulding R,Catley D,Cox LS,Lambart L,Hunt JJ,Nazir N,Shireman T,Richter KP

    更新日期:2014-07-01 00:00:00

  • Time-dependent effect of non-Hodgkin's lymphoma grade on disease-free survival of relapsed/refractory patients treated with high-dose chemotherapy plus autotransplantation.

    abstract::Evaluation of time to event outcomes usually is examined by the Kaplan-Meier method and Cox proportional hazards models. We developed a modified statistical model based on histologic grade and other variables to describe the time-dependent outcome for autologous stem cell transplant (autotransplant) performed for non-...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2007.07.005

    authors: Fu P,van Heeckeren WJ,Wadhwa PD,Bajor DJ,Creger RJ,Xu Z,Cooper BW,Laughlin MJ,Gerson SL,Koç ON,Lazarus HM

    更新日期:2008-03-01 00:00:00

  • Rationale, design and pilot feasibility results of a smartphone-assisted, mindfulness-based intervention for smokers with mood disorders: Project mSMART MIND.

    abstract:BACKGROUND:Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with conting...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2017.12.014

    authors: Minami H,Brinkman HR,Nahvi S,Arnsten JH,Rivera-Mindt M,Wetter DW,Bloom EL,Price LH,Vieira C,Donnelly R,McClain LM,Kennedy KA,D'Aquila E,Fine M,McCarthy DE,Graham Thomas J,Hecht J,Brown RA

    更新日期:2018-03-01 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

  • An online randomised controlled trial to assess the feasibility, acceptability and potential effectiveness of 'Living with Bipolar': a web-based self-management intervention for bipolar disorder: trial design and protocol.

    abstract:BACKGROUND:Bipolar Disorder (BD) is a common and severe form of mental illness. Pharmacotherapy is the main treatment offered, but has limited effectiveness, and there is increasing evidence that people with BD respond well to psychological interventions. Inequalities in access to face-to-face psychological interventio...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.02.011

    authors: Todd NJ,Solis-Trapala I,Jones SH,Lobban FA

    更新日期:2012-07-01 00:00:00

  • Efficacy, safety, and tolerability of lubiprostone for the treatment of non-alcoholic fatty liver disease in adult patients with constipation: The LUBIPRONE, double-blind, randomised, placebo-controlled study design.

    abstract:BACKGROUND:This paper reports the protocol of a randomised, double-blind, placebo-controlled study to test the efficacy, safety, and tolerability of lubiprostone (LUB) vs. placebo on suppressing gut permeability in non-alcoholic fatty liver disease (NAFLD) patients with constipation. NAFLD, including non-alcoholic stea...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2018.04.002

    authors: Kessoku T,Imajo K,Kobayashi T,Honda Y,Kato T,Ogawa Y,Tomeno W,Kato S,Higurashi T,Yoneda M,Kirikoshi H,Kubota K,Taguri M,Yamanaka T,Usuda H,Wada K,Saito S,Nakajima A

    更新日期:2018-06-01 00:00:00

  • Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial.

    abstract:BACKGROUND:Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. METHODS:This 5-site open-...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.01.005

    authors: Lee JD,Friedmann PD,Boney TY,Hoskinson RA Jr,McDonald R,Gordon M,Fishman M,Chen DT,Bonnie RJ,Kinlock TW,Nunes EV,Cornish JW,O'Brien CP

    更新日期:2015-03-01 00:00:00

  • Incentivizing healthy lifestyle behaviors to reduce cardiovascular risk in people with serious mental illness: An equipoise randomized controlled trial of the wellness incentives program.

    abstract:BACKGROUND:Medicaid recipients with serious mental illness die 25-30 years earlier than people in the general population due to health conditions that are modifiable through lifestyle changes. Cardiovascular diseases from excess weight, smoking, and sedentary lifestyle contribute substantially to this life expectancy d...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2019.04.005

    authors: Pratt SI,Brunette MF,Wolfe R,Scherer EA,Xie H,Bartels S,Ferron JC,Capuchino K

    更新日期:2019-06-01 00:00:00

  • Lessons learned in the conduct of a global, large simple trial of treatments indicated for schizophrenia.

    abstract::Large, "practical" or streamlined trials (LSTs) are used to study the effectiveness and/or safety of medicines in real world settings with minimal study imposed interventions. While LSTs have benefits over traditional randomized clinical trials and observational studies, there are inherent challenges to their conduct....

    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.2012.12.001

    authors: Kolitsopoulos FM,Strom BL,Faich G,Eng SM,Kane JM,Reynolds RF

    更新日期:2013-03-01 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

  • Clinical trials profile: professionals and sites.

    abstract::Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. Clinical trials that comply with international and national regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate clinical trial groups in Brazil: pro...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2010.06.002

    authors: Paschoale HS,Barbosa FR,Nita ME,Carrilho FJ,Ono-Nita SK

    更新日期:2010-09-01 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

  • A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol.

    abstract::Upstream interventions - e.g. housing programs and community health worker interventions- address socioeconomic and behavioral factors that influence health outcomes across diseases. Studying these types of interventions in clinical trials raises a methodological challenge: how should researchers measure the effect of...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.12.009

    authors: Kangovi S,Mitra N,Turr L,Huo H,Grande D,Long JA

    更新日期:2017-02-01 00:00:00