Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders
Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders With PTSD: Pilot Randomized Controlled Trial
研究概览
详细说明
The proposed study will assess the feasibility and acceptability of a lifestyle intervention, including a Mediterranean Diet (MedDiet) with a physical activity (PA) component. The study is a pilot randomized control trial (RCT) among WTC responders with PTSD who have overweight and obesity. The 10-week intervention has two-arms, the intervention (MedDiet) with tips to increase PA (n=30) and control (care as usual n=30).
The high dose and high fidelity intervention combines several previously tested intervention modalities, including individual nutrition counseling, group cooking sessions, and communication and education through smartphones, including motivational texts & reminders, videos, teach-back surveys, and goal setting. While the main goal of the intervention is to assess the feasibility and acceptability of the intervention, the study will also assess changes in the overall dietary intake, the MedDiet score, and PA of the intervention group and between the two groups from baseline, post-intervention, and 3-month follow-up. The hypothesis is that the intervention group will experience a significant increase in the MedDiet score and PA activity from baseline to post-intervention; compared to the control group, the intervention group will achieve a significantly higher MedDiet score and will engage in more PA after the intervention.
Changes in body weight, inflammatory biomarkers, and prevalence of metabolic syndrome (MetS) in the intervention group and between the two groups from baseline to post-intervention will be explored; whether changes in inflammatory biomarkers, are moderated by changes in MetS, body weight, or MedDiet score will also be explored. The hypothesis is that the intervention group will experience a significant decrease in inflammatory biomarkers and prevalence in MetS from baseline to post-intervention; compared to the control group, the intervention group will achieve a significantly higher decrease in these measures; the decline in inflammatory biomarkers will be moderated by a reduction in the prevalence of MetS and/or increase in MedDiet score.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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Commack、New York、美国、11725
- World Trade Center Health Program Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- BMI range: 27-40
- PCL score: ≥40
- MOCA score: ≥22
- have a smartphone
- able to follow a diet intervention
- no physical disabilities which prevent exercising
Exclusion Criteria:
- active cancer or history of GI-related cancer in the last 3 years
- autoimmune disease
- history of surgical weight loss
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Mediterranean Diet & Physical Activity
Nutrition with a Physical Activity component.
10-week intervention implementing the Mediterranean Diet.
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At the beginning of each week (1-10), members were sent a text message introducing the week and providing the link to the week's website. This website includes downloadable material for this group with recipes and other important nutrition information, as well as the weekly topic information and informative video. After receiving the link to the website, members received a Qualtrics survey with a teach-back question related to the video and a goal-setting question related to the topics of the week. At the end of each week, members received another Qualtrics survey with a question regarding the goal of the past week.
其他名称:
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有源比较器:Usual Care
Usual care involves one-on-one monthly nutrition counseling
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As part of usual care, members attended one-on-one monthly counseling sessions with the assigned dietitian and reviewed their current eating habits and physical activity, as well as other environmental factors that may be affecting their weight such as work, home environment, sleeping issues, and medications.
After reviewing current practices, the RD provided medical nutrition therapy (MNT), a specific application of the Nutrition Care Process in clinical settings that focuses on the management of diseases (e.g.
diabetes, heart disease, etc.).
Specific dietary recommendations are based on the Bull's Eye Food Guide, used by Stony Brook University Hospital for outpatient nutrition counseling.
Individuals in the standard care received more individualized calorie recommendations (usual care) than the Mediterranean diet group.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Mediterranean diet score
大体时间:9 months
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Participant's Mediterranean diet score is measured with a 14-item Mediterranean diet scale; possible score range 0-14. The Mediterranean Diet questionnaire will be given at each participant visit with the dietitians and at baseline, post, and at 3-month follow up |
9 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Physical activity
大体时间:9 months
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Daily step count is measured with Fitbit that was worn over seven days.
Physical activity are measured at baseline, post-intervention, and 3-month follow up.
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9 months
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Body mass index (BMI)
大体时间:9 months
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Body mass index (weight/height square) will be objectively measured at baseline, post intervention and at 3-month follow up. Body mass index: weight in kilograms/square of height in meters |
9 months
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Waist Circumference
大体时间:9 months
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Waist circumference is measured at baseline, post-intervention, and 3-month follow up. Waist circumference cut off (Women>88cm; Men>102 cm) |
9 months
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Total cholesterol
大体时间:9 months
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Total cholesterol is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 125 to 200mg/dL
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9 months
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oxidized LDL
大体时间:9 months
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Serum oxLDL is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 10-170 ng/mL
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9 months
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HDL cholesterol
大体时间:9 months
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Serum HDL cholesterol was measured at baseline, post-intervention, and at 3-months follow-up; At risk Men: Less than 40 mg/dL (1.0 mmol/L) Women: Less than 50 mg/dL (1.0 mmol/L) |
9 months
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Omega 3 fatty acid
大体时间:9 months
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Serum or plasma Free (Nonester) Fatty Acids Measured at baseline, post-intervention, and at 3-months follow-up. reference range: Optimal >3.2 % Moderate 2.2-3.2 % High <2.2 % |
9 months
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Omega 6 to omega 3 ratio
大体时间:9 months
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Omega 6 is measured at baseline, post-intervention, and at 3-months follow-up; Omega 6/omega 3 ratio: Reference range: 5.7-21.3 (the lower the better) |
9 months
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HA1c
大体时间:9 months
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Serum Hemoglobin A1C (hA1C) is measured at baseline, post-intervention, and 3-month follow up. hA1C: Normal: <5.7% |
9 months
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Cytokines
大体时间:6 months
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The following cytokines will be measured: FNɣ, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-22 and TNFα, high-sensitivity C-reactive protein (hs-CRP) at >3mg/L. The cytokines will be measured at two time points at baseline and post-intervention. |
6 months
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Psychosocial questionnaire
大体时间:9 months
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A total of 40 questions will be used to assess sedentary behaviors, home food availability, social support, self-efficacy, perceived barriers to adhering to lifestyle behaviors reflecting the behavioral strategies that will be addressed in the proposed intervention.
The survey will be completed online at baseline, post-intervention and at 3-month follow up.
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9 months
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PCL score
大体时间:9 months
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Post Traumatic Stress Disorder symptoms will be tested with a PCL score.
PCL is a 20-item self-report measure of current (past month) PTSD symptoms based on the DSM-V criteria.
PCL will be measured at baseline, post intervention and at 3-month follow up
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9 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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