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Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders

2021年11月17日 更新者:Chrisa Arcan, PhD, MHS, MBA, RD、Stony Brook University

Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders With PTSD: Pilot Randomized Controlled Trial

The goal of this randomized control trial (RCT) is to test the feasibility and acceptability of a lifestyle intervention with a focus on implementing a high dose Mediterranean Diet protocol with physical activity to reduce systemic inflammation and body weight among WTC first responders having overweight/obesity and PTSD. The findings of this study will demonstrate the suitability of the proposed approach to reduce comorbidities among similar populations exposed to traumatic events; the findings will also inform the World Trade Center Health Program's extensive research and clinical efforts with the potential to provide a preventive care model to reduce systemic inflammation and related chronic disease among WTC responders with PTSD.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

62

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New York
      • Commack、New York、アメリカ、11725
        • World Trade Center Health Program Clinic

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Mediterranean Diet & Physical Activity
Nutrition with a Physical Activity component. 10-week intervention implementing the Mediterranean Diet.

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.

  • Visit 1: discuss Mediterranean diet score results from baseline and ways to improve
  • Visit 2: discuss anti-inflammatory diet scorecard and ways to improve
  • Discuss optimal dietary pattern (Med Diet pyramid handout)
  • Personal dietary and exercise goals, reviewed baseline intake form, social support, self-efficacy, challenges, or barriers to achieving goals
他の名前:
  • 栄養介入
アクティブコンパレータ:Usual Care
Usual care involves one-on-one monthly nutrition counseling
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.
他の名前:
  • コントロール

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mediterranean diet score
時間枠:9 months

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Physical activity
時間枠:9 months
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.
9 months
Body mass index (BMI)
時間枠:9 months

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
Waist Circumference
時間枠:9 months

Waist circumference is measured at baseline, post-intervention, and 3-month follow up.

Waist circumference cut off (Women>88cm; Men>102 cm)

9 months
Total cholesterol
時間枠:9 months
Total cholesterol is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 125 to 200mg/dL
9 months
oxidized LDL
時間枠:9 months
Serum oxLDL is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 10-170 ng/mL
9 months
HDL cholesterol
時間枠:9 months

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
Omega 3 fatty acid
時間枠:9 months

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
Omega 6 to omega 3 ratio
時間枠:9 months

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
HA1c
時間枠:9 months

Serum Hemoglobin A1C (hA1C) is measured at baseline, post-intervention, and 3-month follow up.

hA1C: Normal: <5.7%

9 months
Cytokines
時間枠:6 months

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
Psychosocial questionnaire
時間枠:9 months
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.
9 months
PCL score
時間枠:9 months
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
9 months

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年12月1日

一次修了 (予想される)

2021年11月30日

研究の完了 (予想される)

2021年11月30日

試験登録日

最初に提出

2021年8月7日

QC基準を満たした最初の提出物

2021年11月17日

最初の投稿 (実際)

2021年11月30日

学習記録の更新

投稿された最後の更新 (実際)

2021年11月30日

QC基準を満たした最後の更新が送信されました

2021年11月17日

最終確認日

2021年11月1日

詳しくは

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