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 to the treatment of obesity is standard behavioral treatment. This approach includes behavior modification related to eating and activity habits. The purpose of this paper is to describe the rationale, design, methods and baseline sample characteristics of a randomized controlled trial of a behavioral intervention in weight loss management, referred to as the PREFER study. METHODS:The PREFER study, using a four-group design, includes: (1) a randomization scheme that permits participants to indicate a preferred dietary treatment approach, and (2) two dietary options, one of which is a lacto-ovo-vegetarian diet that has demonstrated potential for long-term adherence. The intervention (32 treatment sessions) is delivered over 12 months and is followed by a 6-month maintenance phase; final assessment occurs at 18 months. RESULTS:We screened 932 individuals and randomized 197 to the study: Treatment Preference-Yes (n=84) and Treatment Preference-No (n=98). To maintain a balance across the four treatment groups, 15 subjects who preferred the standard diet had to be discarded from the Treatment Preference-Yes group. Retention at 18 months for the first of three cohorts was 82%. CONCLUSIONS:The PREFER study is a single center study and is the first randomized controlled trial examining a lacto-ovo-vegetarian diet as part of weight loss treatment. The ethnically diverse sample includes males and females with a body mass index of 27 to 43. The study has the potential to make a contribution to understanding the role of treatment preference and the potential of a lacto-ovo-vegetarian diet for long-term weight loss.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Burke LE,Choo J,Music E,Warziski M,Styn MA,Kim Y,Sevick MAdoi
10.1016/j.cct.2005.08.002keywords:
subject
Has Abstractpub_date
2006-02-01 00:00:00pages
34-48issue
1eissn
1551-7144issn
1559-2030pii
S1551-7144(05)00131-Xjournal_volume
27pub_type
杂志文章,随机对照试验abstract：:Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this...
journal_title：Contemporary clinical trials
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更新日期：2007-05-01 00:00:00
abstract：:Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white...
journal_title：Contemporary clinical trials
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abstract：:Low/no-income, African American men are disproportionally burdened by chronic disease resulting from a complex interplay of systemic, sociocultural, and individual factors. These disparities are related to poverty, racism, gender role strain, high levels of stress, low levels of physical activity, and malnutritious di...
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abstract：:This randomized, controlled trial tested the effectiveness of a nurse-run, telephone-based intervention to improve lipid control in patients with diabetes. Our patient population is predominantly low-income and Latino. Using our diabetes registry, we randomly assigned 381 patients to continue with their usual care and...
journal_title：Contemporary clinical trials
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doi：10.1016/j.cct.2008.05.011
更新日期：2008-09-01 00:00:00
abstract：:Dosing is potentially the most important decision that must be made when building or refining behavioral interventions. In this paper, we propose standardized terminology and reporting of dosing information, which would inform intervention development, refinement for dissemination, and systematic reviews of dose-respo...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,评审
doi：10.1016/j.cct.2012.07.011
更新日期：2012-11-01 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
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
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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
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abstract：BACKGROUND:Evidence suggests that periodontitis is associated with prevalent and incident type 2 diabetes mellitus (T2DM), raising the question of whether periodontitis treatment may improve glycemic control in patients with T2DM. Meta-analyses of mostly small clinical trials suggest that periodontitis treatment result...
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.2013.09.010
更新日期：2013-11-01 00:00:00
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
更新日期：2019-06-01 00:00:00
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
更新日期：2014-01-01 00:00:00
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
更新日期：2008-01-01 00:00:00
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
更新日期：2017-02-01 00:00:00
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
更新日期：2012-07-01 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：: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
更新日期：2016-03-01 00:00:00
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
更新日期：2017-05-01 00:00:00
abstract：BACKGROUND:Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeut...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.105975
更新日期：2020-04-01 00:00:00
abstract：:It is of vital importance to the success of a randomized clinical trial to maintain the balance of baseline characteristics (covariates) that could potentially confound the outcomes of the trial. Various randomization methods have been proposed to increase the likelihood of having balanced covariates at the end of a t...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2011.03.004
更新日期：2011-07-01 00:00:00
abstract：OBJECTIVE:Feasibility of a clinical-trial comparing a low-glycaemic diet with a low-calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with PCOS. DESIGN:A pilot Randomised-Controlled-Trial using different recruitment strategies. SETTING:A University Hospital ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2009.05.001
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：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
更新日期：2012-01-01 00:00:00
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journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2013.11.007
更新日期：2014-01-01 00:00:00
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
更新日期：2016-07-01 00:00:00
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
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更新日期：2019-04-01 00:00:00
abstract：BACKGROUND:New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists loc...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106169
更新日期：2020-11-01 00:00:00
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
更新日期：2017-06-01 00:00:00
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
更新日期：2015-11-01 00:00:00
abstract：PURPOSE:African-American women (AAW) are more likely to be metabolically unhealthy than White women (WW). Metabolic syndrome (MetS) is associated with increased breast cancer risk and mortality from breast cancer is greater in AAW compared to WW. Data show MetS affects health-related quality of life (HRQoL). Exercise s...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.02.005
更新日期：2018-04-01 00:00:00
abstract：OBJECTIVE:Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chron...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2015.11.018
更新日期：2016-01-01 00:00:00
