LIFE-HOUSE: A Lifestyle Intervention and Functional Evaluation - a Health Outcomes Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- University of Rhode Island Change Assessment (URICA) questionnaire
研究概览
简要总结
The LIFE-HOUSE research project is designed to evaluate the impact of a personalized lifestyle intervention program on functional capacity as an approach to quantitating health, and its relationship to well understood disease risk determinants.
LIFE-HOUSE will utilize an innovative Tent-Umbrella-Bucket design.
Participants will gather under the Tent of an all-inclusive 'N of 1' Case Series providing a shelter of Functional Medicine interventions against the storm of chronic disease. Under this Tent are a collection of Umbrellas where participants with similar clinical challenges are evaluated as clinically defined groups with loose guidelines for the planned interventions. Finally, participants standing under these Umbrellas may step into specific Buckets that gather individuals with nearly identical clinical presentations into more formally described prescriptive randomized arms for intervention.
Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet remain eligible for participation in the overall Tent.
详细描述
It has been suggested that the best medicine should value four principles (4P) - medicine should be personalized, predictive, preventative and participatory. This 4P Medicine will thus be personalized and patient centered with a focus on the person who has the disease and not the disease the person has. It will be predictive as it identifies the pre-clinical trend/decline towards illness sooner than onset of symptoms that herald the loss of function and health. It will be preventative as the information gathered should offer opportunities to modify these trajectories towards illness and finally it will be participatory as individuals will be intimately involved in the gathering of data to identify trends and in the application of lifestyle measures to improve their lives.
There is a significant unmet need to identify the value of a personalized lifestyle intervention program for improving functional health outcomes. Whereas disease is well understood from traditional pathology-based indices, health is less easily defined. Historically, healthy has been the default term that is applied to an individual who is not recognized as having a disease. This definition of health as the absence of disease has resulted in the delivery of health and wellness as often lying outside the purview of medicine.
An evolving definition of health, however, is to recognize that it is related to the functional capacity of the individual. Functional capacity can be categorized in four assessment areas: physiological, physical, cognitive and emotional. All four of these subcategories are quantifiable by both qualitative and quantitative metrics. The effects on health of a multi-modal personalized lifestyle medicine intervention program can best be evaluated by using functional determinants.
Functional Medicine is an integrative medicine philosophy that uniquely incorporates 4P Medicine with a focus on function and dysfunction and the necessity to consider the physiological events that determine the balance between the two. The LIFE-HOUSE research project is designed to evaluate the impact of a personalized lifestyle intervention program on functional capacity as an approach to quantitating health, and its relationship to well understood disease risk determinants.
Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet remain eligible for participation in the overall Tent. Due to the structure of the uniquely defined yet overlapping system of Umbrellas and Buckets, a specific Subject may participate consecutively and/or sequentially in a series of Umbrella and Buckets as applicable and their data may be included in multiple Umbrella and Bucket analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elevated Homocysteine Level ≥ 10.4 µmol/L
排除标准
- •MOS SF-36 QN general score < 60
- •Dental Health Umbrella:
- •Specific Inclusion Criteria:
- •Participants with extensive gingivitis/periodontitis/Caries/Painful teeth/Fractured Teeth. Identification of any of the following on physical exam: gingivitis, receding gumlines, periodontitis, fractured teeth, multiple unrestored caries. Identification on history of bleeding gums, bleeding while flossing, bleeding when brushing, chronic sores in the mouth, painful teeth, pain when biting on aluminum foil.
- •Neurological Health Umbrella:
- •Specific Inclusion Criteria:
- •Elevated score on any subscale of Depression Anxiety Stress Scale (DASS) QN; and/or a score demonstrating mild or moderate depression or anxiety on Beck Depression Score and Beck Anxiety Score; and/or a MOS SF-36 subscale Emotional Role Functioning or Mental Health < 50; and/or PROMIS Cognitive Function QN score <
- •Autoimmune and Inflammatory Conditions Umbrella:
- •Specific Inclusion Criteria:
- •Symptoms, signs, laboratory biomarkers or diagnosis consistent with the features/diagnosis of an Autoimmune/Inflammatory Condition (excluding metabolic disorders/atherosclerosis) and ill-defined conditions characterized by symptomatic fatigue/myalgias.
- •Elevated ANA Bucket:
- •Specific Inclusion Criteria:
- •General Inclusion Criteria for Autoimmune and Inflammatory Conditions Umbrella
- •Elevated ANA Level > 1:40 titer (A specified sub-group for analysis will be all with two baseline elevated ANA Level > 1:40 titer.)
- •Specific Exclusion Criteria:
- •Symptoms, signs, laboratory biomarkers (excluding ANA) or diagnosis consistent with the features/diagnosis of an Autoimmune/Inflammatory Condition (excluding metabolic disorders/atherosclerosis)
- •Autoimmune Conditions Bucket:
- •Specific Inclusion Criteria:
- •Established Diagnosis of an autoimmune condition (Systemic Lupus Erythematosus, Rheumatoid Arthritis, Inflammatory Bowel Disease and Hashimoto's Thyroiditis) with ANA level >1:80 titer, rheumatoid factor (RF) ≥ 14 IU/ml, fecal calprotectin ≥ 50 mcg/g and thyroid autoantibody levels specifically thyroglobulin antibodies ≥ 115 IU/ml and/or thyroid peroxidase antibodies ≥ 35 IU/ml.
- •Symptomatic Fatigue and Myalgia Bucket:
- •Specific Inclusion Criteria:
- •Two of the following five features have been generally present for at least 3 months:
- •Widespread bodily pain (pain in 3 of 5 regions (Left upper, right upper, left lower, right lower, axial) with and without symptomatic trigger points
- •Generalized fatigue
- •Sleep disturbances including awakening unrefreshed
- •Cognitive (memory or thought) problems
- •Post-exertional malaise
- •Gastrointestinal Health Umbrella:
- •Specific Inclusion Criteria:
- •Symptoms, signs, laboratory biomarkers or diagnosis consistent with the features/diagnosis of Irritable Bowel Syndrome and other GI symptomatology (excluding Inflammatory Bowel Disease) as well as physiological challenges with healthy detoxification
- •IBS Bucket:
- •Specific Inclusion Criteria:
- •Symptoms, signs, laboratory biomarkers or diagnosis consistent with the features/diagnosis of Irritable Bowel Syndrome and other GI symptomatology (excluding Inflammatory Bowel Disease)
- •Detoxification Bucket:
- •Specific Inclusion Criteria:
- •Symptoms, signs, laboratory biomarkers or diagnosis consistent physiological challenges with healthy detoxification
- •Wellness Detoxification Bucket:
- •Specific Inclusion Criteria:
- •Symptoms, signs, laboratory biomarkers or diagnosis consistent physiological challenges with healthy detoxification
- •Metabolic Health Umbrella:
- •Specific Inclusion Criteria:
- •BMI>= 18.5 and <40
- •Consequences of Metabolic Function/Dysfunction Bucket - Crossover Design:
- •Specific Inclusion Criteria:
- •BMI>= 18.5 and <40
- •Metabolic Dysfunction is defined as having at least two of the following: Glucose ≥ 100 mg/dl; Homeostatic Model of Assessment for Insulin Resistance (HOMA-IR) (Glucose [mg/dl]Insulin [µiu/L)/405), score ≥ 2.0; HbA1c ≥ 5.7%; Triglycerides ≥ 100 mg/dl; Low Density Lipoprotein Particle Number (LDLp) >1000, lipoprotein (a) (lp(a)) > 30 mg/dl ; HDL (women) ≤ 50 ng/ml; HDL (men) ≤ 40 ng/ml; and blood pressure ≥ 135/85 mm Hg.
- •Specific Exclusion Criteria:
- •Any of the following: Fasting Blood Glucose ≥ 125mg/dl; HbA1c ≥ 6.5% and Blood Pressure ≥ 165/95 mm Hg.
- •Consequences of Metabolic Function/Dysfunction Bucket - Randomization/Inclusion Design:
- •Specific Inclusion Criteria:
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结局指标
主要结局
University of Rhode Island Change Assessment (URICA) questionnaire
时间窗: Change from baseline at 12 months
URICA questionnaire is a 32 item self-report measure that includes 4 subscales measuring the stages of change: Precontemplation, Contemplation, Action, and Maintenance (there is also a 24 item version). Responses are given on a 5 point Likert scale ranging from (1=strong disagreement to 5=strong agreement),
Depression Anxiety, Stress Scale (DASS) questionnaire
时间窗: Change from baseline at 12 months
The Depression, Anxiety and Stress Scale is a 21 items questionnaire that includes a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Outcome is divided into normal, mild, moderate, severe, and very severe for each of the 3 categories: Depression, Anxiety, and Stress. A low score represents the normal and the higher the score the more severe the outcome.
Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire
时间窗: Change from baseline at 12 months
The MOS SF-36 is an indicator of overall health status. It has an eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability.
次要结局
- Weight(Change from baseline at12 months)
- Glucose(Change from baseline at 12 months)
- High sensitivity C-Reactive Protein (Hs-CRP)(Change from baseline at 12 months)
- Omega-3 Fatty Acids(Change from baseline at 12 months)
- Total Cholesterol(Change from baseline at 12 months)
- Waist to Hip Ratio (WHR)(Change from baseline at 12 months)
- Homocysteine(Change from baseline at 12 months)
- Body Mass Index (BMI)(Change from baseline at 12 months)
- Waist Circumference (WC)(Change from baseline at 12 months)
- Height(Change from baseline at 12 months)
- Hip Circumference (HC)(Change from baseline at12 months)
- 25-hydroxy (OH) Vitamin D3(Change from baseline at 12 months)
- Anti-Nuclear Antibodies (ANA)(Change from baseline at 12 months)
- Beck Depression Inventory (BDI)(Change from baseline at 12 months)
- Beck Anxiety Inventory (BAI)(Change from baseline at12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Test(Change from baseline at 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Test(Change from baseline at12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form (SF)(Change from baseline at 12 months)