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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammation; Metabolic Syndrome; Overweight and Obesity; Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Mediterranean Diet & Physical Activity; Behavioral: Usual Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Commack, New York, United States, 11725
      • World Trade Center Health Program Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean Diet & Physical Activity; Nutrition with a Physical Activity component. 10-week intervention implementing the Mediterranean Diet.	Behavioral: Mediterranean Diet & Physical Activity; 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; Other Names: Nutrition Intervention
Active Comparator: Usual Care; Usual care involves one-on-one monthly nutrition counseling	Behavioral: Usual Care; 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.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mediterranean diet score	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	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)	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	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	Total cholesterol is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 125 to 200mg/dL	9 months
oxidized LDL	Serum oxLDL is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 10-170 ng/mL	9 months
HDL cholesterol	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	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	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	Serum Hemoglobin A1C (hA1C) is measured at baseline, post-intervention, and 3-month follow up. hA1C: Normal: <5.7%	9 months
Cytokines	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	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	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

Collaborators and Investigators

• Sponsor: Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: August 7, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Physical Activity; Metabolic Syndrome; Mediterranean Diet; Post-Traumatic Stress Disorder; Overweight and Obesity; World Trade Center Responders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Trauma and Stressor Related Disorders; Insulin Resistance; Hyperinsulinism; Inflammation; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Metabolic Syndrome; Overweight; Body Weight
• Other Study ID Numbers: U01OH012057 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No