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

Not Applicable

• Conditions: Metabolic Syndrome; Post-Traumatic Stress Disorder; Overweight and Obesity; Inflammation
• Interventions: Behavioral: Usual Care; Behavioral: Mediterranean Diet & Physical Activity

• Registration Number: NCT05138198
• Lead Sponsor: Stony Brook University

Brief Summary

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.

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 Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-08-07
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-17
• Last Update Submitted: 2021-11-17
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Study First Posted: 2021-11-30
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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

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Exclusion Criteria

• active cancer or history of GI-related cancer in the last 3 years
• autoimmune disease
• history of surgical weight loss

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Usual care involves one-on-one monthly nutrition counseling
Mediterranean Diet & Physical Activity	Mediterranean Diet & Physical Activity	Nutrition with a Physical Activity component. 10-week intervention implementing the Mediterranean Diet.

Primary Outcome Measures

Name	Time	Method
Mediterranean diet score	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

Secondary Outcome Measures

Name	Time	Method
Omega 6 to omega 3 ratio	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)
HA1c	9 months	Serum Hemoglobin A1C (hA1C) is measured at baseline, post-intervention, and 3-month follow up.; hA1C: Normal: \<5.7%
Cytokines	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.
Psychosocial questionnaire	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.
PCL score	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
Physical activity	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.
Body mass index (BMI)	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
Waist Circumference	9 months	Waist circumference is measured at baseline, post-intervention, and 3-month follow up.; Waist circumference cut off (Women\>88cm; Men\>102 cm)
Total cholesterol	9 months	Total cholesterol is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 125 to 200mg/dL
oxidized LDL	9 months	Serum oxLDL is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 10-170 ng/mL
HDL cholesterol	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)
Omega 3 fatty acid	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 %

Trial Locations

Locations (1)

World Trade Center Health Program Clinic; 🇺🇸 Commack, New York, United States