A National Trial of the ELM Lifestyle Program and Remission of the Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 618
- 试验地点
- 10
- 主要终点
- Remission of Metabolic Syndrome
研究概览
简要总结
This is a multi-center behavioral randomized trial with the aim of comparing a group-based lifestyle intervention with a self-directed lifestyle intervention on remission of the metabolic syndrome over 2 years of follow-up.
详细描述
The purpose of this trial is to determine the efficacy and cost-effectiveness of the Group-Based and Self-Directed ELM lifestyle programs when offered on a national level. A multi-site randomized trial will be conducted on 600 patients with the metabolic syndrome (MetS) by five national sites, each of which will randomize 120 patients to the Group-Based or Self-Directed programs. The Group-Based program targets healthy eating, physical activity, and stress reduction and is based upon neuroscience studies showing that mindful habits provide resilience against the power of emotions to subvert intention, and social science studies showing that sustainability is enhanced by support from a health network. The Self-Directed program represents enhanced usual care based upon what is currently offered in medicine and wearable technology for treatment of adults with MetS and its components. The primary outcome is remission of MetS at 2 years. Secondary outcomes include cost-effectiveness, vegetable intake, physical activity, and mindful awareness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with metabolic syndrome, defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO (Alberti, 2009). Note that hemoglobin A1c will be measured as a marker of impaired glucose metabolism, but will not be considered in determining metabolic syndrome status. To meet metabolic syndrome criteria the participant should have ≥ 3 of the following five criteria:
- •Waist circumference based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women
- •Fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides
- •Fasting HDL cholesterol <40 mg/dL in men or <50 mg/dL in women, or treatment for low HDL
- •Systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or treatment for hypertension
- •Fasting plasma glucose 100-125 mg/dL (range inclusive)
- •Greater than 18 years of age
排除标准
- •Unable to walk 2 consecutive blocks without assistance, based on patient report.
- •Unwilling, unable, or not ready to make the lifestyle changes prescribed in ELM
- •Unwilling to be randomized to either arm of the trial
- •Unable or unwilling to give an informed consent, communicate with study staff, or complete the study run-in period. The run-in period requires attending an information session, completing two assessment visits within the scheduled time (potential participant is allowed to reschedule once), wearing an accelerometer, and completing lifestyle logs (see protocol)
- •Does not have reliable access to the internet via a computer or mobile device
- •Not fluent in English
- •Current diagnosis of type 1 or type 2 diabetes, or on any diabetes medications except metformin
- •Inpatient treatment for a psychiatric condition within the past 6 months, or currently receiving treatment for schizophrenia or other serious psychiatric illness
- •Probable major depression, defined as a PHQ-8 score ≥10
- •Pregnant women, planning a pregnancy in the next 24 months, given birth in the last 6 months, or currently breastfeeding
- •≥ 30 total days of oral corticosteroid use within the last year, history of solid organ transplant, or history of stem cell transplant
- •Problematic use of alcohol and/or recreational drugs based on the ASSIST screening tool (score of ≥27).
- •Self-reported or known history of an eating disorder (e.g., binging and purging) in the past 5 years
- •Use of weight loss medications (Qsymia, phentermine, etc.) or supplements in the last 3 months, or unwilling to abstain from taking weight loss medications or supplements during the study
- •History of bowel resection surgery or bariatric surgery
- •Participant does not have, or is unwilling to seek care from, a primary care physician at the time of enrollment
- •Any medical condition known to influence the etiology of MetS as judged by the study physician (e.g., uncontrolled hypothyroidism, endocrine hypertension, etc)
- •History of major cardiovascular illness, including a) stroke; b) myocardial infarction; c) congestive heart failure requiring hospitalization, or greater than NYHA heart failure class I; d) uncontrolled hypertension (SBP>180 or DBP > 105); e) unstable angina; or f) other major cardiovascular illness which the site PI determines could limit ability to participate in the trial.
- •Behavioral/logistical barriers to trial participation or engagement, e.g., a scheduled major surgery, scheduling difficulties, travel plans, moving outside the study area
- •Cognitive impairment, defined by a Montreal Cognitive Assessment (MoCA) score of ≤
- •The MoCA will be administered only when research staff suspect cognitive impairment
- •Visual or hearing impairment
- •Severe food allergies or food intolerances/preferences that preclude participation in the ELM program
- •Currently taking or expecting to take any of the following exclusionary medications:
- •Antiretroviral therapy (e.g., HAART)
- •Weight loss medications (as in #14)
- •Medications known to significantly influence weight or metabolic outcomes
- •Diabetes drugs other than metformin (as in #7)
- •Participation in any clinical trial, until at least six months following the end of the intervention phase. Individuals in long-term follow-up (over 6 months post intervention) may be enrolled in ELM.
- •Cancer treatment within the last 6 months, excluding chemoprophylaxis or treatment for non-melanoma skin cancer.
- •Previous participation in an ELM program or currently living with ELM participant.
结局指标
主要结局
Remission of Metabolic Syndrome
时间窗: Measured at 24 months following treatment assignment.
Compare the Group-Based and Self-Directed arms on the proportion of participants who are in remission of the metabolic syndrome (MetS) at 2 years. MetS is defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO as having 3 or more risk factors for cardiovascular disease. To be considered in remission of MetS the participant must have less than 3 of the following 5 criteria: 1) Waist circumference based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women; 2) Fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides; 3) Fasting HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women, or treatment for low HDL; 4) Systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or treatment for hypertension; and 5) Fasting plasma glucose 100-125 mg/dL. Analysis will be performed on pre-determined subgroups: education, sex, site, weight, BMI, MetS severity, race, income # of comorbidities, self-efficacy, and age.
次要结局
- Physical activity(Measured at 6, 15, and 24 months following treatment assignment.)
- Habit formation(Measuring at 6, 15, and 24 months following treatment assignment.)
- Depressive symptoms(Measuring change from baseline at 6, 15, and 24 months following treatment assignment.)
- Hemoglobin A1c levels(Measured at baseline and 6, 15, and 24 months following treatment assignment.)
- Sugar-sweetened beverages(Assessed during in-person participant assessments conducted at baseline and 6, 15, and 24 months following treatment assignment.)
- Vegetable consumption(Measured at 6, 15, and 24 months following treatment assignment)
- Cost of Medications(Measured at 6, 15, and 24 months following treatment assignment.)
- Number of Prescribed Medications(Measured at 6, 15, and 24 months following treatment assignment.)
- Body Mass Index(Measured at baseline and 6, 15, and 24 months following treatment assignment.)
- Cost-effectiveness(Measured over the 24 month patient participant follow-up period)
- Weight Loss(Measuring change from baseline at 6, 15, and 24 months following treatment assignment.)
- Triglycerides (metabolic syndrome component)(Measured at baseline and 6, 15, and 24 months following treatment assignment.)
- Energy and vitality Index(Measured at baseline and 6, 15, and 24 months following treatment assignment.)
- Healthcare utilization(Measured over the 24 month patient participant follow-up period)
- Severity of Metabolic Syndrome(Measured at 6, 15, and 24 months following treatment assignment.)
- ≥ 5% body weight loss(Measuring change from baseline at 6,15, and 24 months following treatment assignment.)
- High-Density Lipoproteins (HDL) Cholesterol (metabolic syndrome component)(Measured at baseline and 6, 15, and 24 months following treatment assignment.)
- Frequency of Contacts within Health network(Measuring change from baseline at 6, 15, and 24 months following treatment assignment.)
- Perceived stress(Measuring change from baseline at 6, 15, and 24 months following treatment assignment.)
- Social support for diet(Measured at 6, 15, and 24 months following treatment assignment.)
- Social support for exercise(Measured at 6, 15, and 24 months following treatment assignment.)
- Eating competence(Measured at baseline and 6, 15, and 24 months following treatment assignment.)
- Facets of Mindfulness(Measuring change from baseline mindfulness at 6, 15, and 24 months following treatment assignment.)
- Blood Pressure (metabolic syndrome component)(Measured at baseline and 6, 15, and 24 months following treatment assignment.)
- Waist Circumference (metabolic syndrome component)(Measured at baseline and 6, 15, and 24 months following treatment assignment.)
- Fasting Plasma Glucose (metabolic syndrome component)(Measured at baseline and 6, 15, and 24 months following treatment assignment.)
- Impact of pandemic(Measured at 24 months following treatment assignment.)
研究者
Lynda Powell, PhD, MEd
Professor of Preventive Medicine
Rush University Medical Center