Abstract:
BACKGROUND:Extant obesity efforts have had a limited impact among low-income underserved children, in part because existing programs are limited in terms of their short duration and low dosage, limited accessibility and sustainability; and failure to address barriers faced by diverse low-income families. METHODS:This two-arm, parallel, randomized controlled trial (RCT) tests whether delivering obesity prevention, as part of an ongoing home visitation program (HVP), is an effective approach for primary (infants) and secondary (mothers) obesity prevention among low-income, underserved families. This RCT further examines the role of maternal and social factors as key mechanisms of transmission of infants' obesity risk, and the real-life costs of delivering obesity prevention as part of HVPs. Specifically, 300 low-income mothers/infants (6mo at baseline) participating in the Healthy Families America home visitation program in Antelope Valley (CA) will be recruited and enrolled in the study. Home visitors serving families will be randomly assigned to deliver the standard HVP curriculum with or without obesity prevention as part of their weekly home visits for two years. Anthropometric, metabolic and behavioral assessments of mothers/infants will be conducted at enrollment and after 6 and 18 months of intervention. DISCUSSION:This study addresses the need to develop interventions targeting at-risk infants before they become obese. The proposed research is timely as the Institute of Medicine, the United States Department of Agriculture, and the Department of Health and Human Services are revising their recommendations to address key factors influencing obesity risk in children from birth to 24 months of age.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
de la Haye K,Fluke M,Laney PC,Goran M,Galama T,Chou CP,Salvy SJdoi
10.1016/j.cct.2018.12.010subject
Has Abstractpub_date
2019-02-01 00:00:00pages
61-69eissn
1551-7144issn
1559-2030pii
S1551-7144(18)30541-Xjournal_volume
77pub_type
杂志文章,随机对照试验abstract:OBJECTIVE:Endometriosis is a chronic, estrogen dependent condition that affects 5-10% of reproductive aged women and is associated with pelvic pain and infertility. As the approach to therapy shifts from surgical ablation to pharmacological control, a non-surgical mode of diagnosis would be desirable. The ENDOmarker st...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2018.03.002
更新日期:2018-05-01 00:00:00
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
更新日期:2015-05-01 00:00:00
abstract::Managing chronic pain effectively is often challenging for health care providers and patients. Telehealth technologies can bridge geographic distance and improve patients' quality of care in communities where access to pain specialists has previously been unavailable. This paper describes the development and evaluatio...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2014.05.005
更新日期:2014-07-01 00:00:00
abstract::Breast cancer is the most common invasive cancer among women in developed countries. Obesity is a major risk factor for breast cancer recurrence and mortality in both pre- and postmenopausal women. Co-morbid medical conditions are common among breast cancer survivors. The Exercise and Nutrition to Enhance Recovery and...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.12.003
更新日期:2013-03-01 00:00:00
abstract::Although therapeutic treatments exist for substance use disorder (SUD), about half of individuals who enter treatment leave early and relapse to substance use. Early dropout from residential treatment places individuals at risk of relapse, and women in SUD residential treatment represent a vulnerable population. Evide...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.09.004
更新日期:2017-11-01 00:00:00
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
更新日期:2009-05-01 00:00:00
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
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE:Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the firs...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.06.002
更新日期:2017-09-01 00:00:00
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
更新日期:2019-05-01 00:00:00
abstract::Caregivers for a family member with dementia experience chronic long-term stress that may benefit from new complementary therapies such as mindfulness-based stress reduction. Little is known however, about the challenges of recruiting and retaining family caregivers to research on mind-body based complementary therapi...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2011.05.002
更新日期:2011-09-01 00:00:00
abstract:BACKGROUND:Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervent...
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.2019.105816
更新日期:2019-09-01 00:00:00
abstract:BACKGROUND:Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. OBJECTIVES:The Home Blood Pressure Telemonitorin...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.03.014
更新日期:2012-07-01 00:00:00
abstract:BACKGROUND:The Covid-19 pandemic has caused fear and panic worldwide, forcing healthcare systems to disregard conventional practices and adopt innovation to contain the infection and death. Globally, there has been a rapid proliferation of research studies and clinical trials assessing risks, infectivity and treatment....
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2020.106106
更新日期:2020-09-01 00:00:00
abstract:PURPOSE:By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLW...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106047
更新日期:2020-08-01 00:00:00
abstract::Competency-Based Approaches to Community Health (COACH) is a randomized controlled trial of a family-centered, community-based, and individually-tailored behavioral intervention for childhood obesity among Latino pre-school children. COACH focuses on improving personal agency for health behavior change by tailoring co...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.08.006
更新日期:2018-10-01 00:00:00
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
更新日期:2018-06-01 00:00:00
abstract:BACKGROUND:Multiple sclerosis is a chronic progressive neurological disease. Evidence attests to the benefits of exercise, guidelines for exercise in multiple sclerosis are available. Remote-delivery of exercise adherence programmes based on the exercise guidelines require urgent testing. AIMS:The design, and outcomes...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2021.106281
更新日期:2021-01-12 00:00:00
abstract::Phase IIA clinical trials are commonly conducted as pilot studies to evaluate efficacy and safety in selected populations of patients with the disease or condition to be treated or prevented. The efficacy objective is to find preliminarily evidence of the effectiveness or ineffectiveness of study treatments. Go/no-go ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.07.006
更新日期:2012-11-01 00:00:00
abstract:INTRODUCTION:When the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guide...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.105963
更新日期:2020-04-01 00:00:00
abstract:BACKGROUND:Women have higher rates of depression and often experience depression symptoms during critical reproductive periods, including adolescence, pregnancy, postpartum, and menopause. Collaborative care intervention models for mood disorders in patients receiving care in an OB-GYN clinic setting have not been eval...
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.2013.08.001
更新日期:2013-11-01 00:00:00
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
更新日期:2013-03-01 00:00:00
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
更新日期:2009-09-01 00:00:00
abstract::The 2-in-1 adaptive design [Chen et al. 2018] allows seamless expansion of an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program. An intermediate endpoint can be used for the adaptive decision. Under a mild assumption that is expected to generally hold in practice, both the Phase 2 trial...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106053
更新日期:2020-08-01 00:00:00
abstract:INTRODUCTION:In promoting the health of chronically ill children, the hospital should help children cope both medically and psychosocially with their disease. The University Children's Hospital of Nancy proposes adapted physical activity for hospitalized children, but the practice during hospitalization is not well dev...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2009.12.003
更新日期:2010-03-01 00:00:00
abstract:BACKGROUND:Laxatives are much utilized, but few clinical trials assessed the efficacy of phytotherapics in the functional constipation. AIM:The aim of this study was to evaluate the efficacy of the tincture of jalapa in the treatment of patients with functional constipation. METHODS:Double-blind, randomized, placebo-...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2010.10.011
更新日期:2011-03-01 00:00:00
abstract::Recruiting sufficient patients within an acceptable time horizon is an issue for most clinical trials and is especially challenging in the field of rare diseases. It is therefore an attractive option to include historical data from previous (pilot) trials in the current study thus reducing the recruitment burden. In c...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2017.07.013
更新日期:2017-12-01 00:00:00
abstract:INTRODUCTION:Focal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control....
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2013.06.005
更新日期:2013-09-01 00:00:00
abstract:INTRODUCTION:Excessive recreational screen time (i.e., screen use for entertainment) is a global public health issue associated with adverse mental and physical health outcomes. Considering the growing popularity of screen-based recreation in adolescents, there is a need to identify effective strategies for reducing sc...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2014.12.001
更新日期:2015-01-01 00:00:00
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
更新日期:2015-11-01 00:00:00
abstract::Dyslipidemia and insulin resistance occur in a large proportion of HIV-infected patients treated with highly active antiretroviral therapy (HAART); anthropomorphic changes, such as lipoatrophy and central obesity, occur in a subset of patients. This cluster of clinical features, which is termed HIV lipodystrophy, plac...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2006.07.002
更新日期:2006-12-01 00:00:00