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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05138198
• Other study ID #: U01OH012057
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2021
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Inflammation
• Metabolic Syndrome
• Overweight
• Overweight and Obesity
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	World Trade Center Health Program Clinic	Commack	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Total cholesterol	Total cholesterol is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 125 to 200mg/dL	9 months
Secondary	oxidized LDL	Serum oxLDL is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 10-170 ng/mL	9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	HA1c	Serum Hemoglobin A1C (hA1C) is measured at baseline, post-intervention, and 3-month follow up.; hA1C: Normal: <5.7%	9 months
Secondary	Cytokines	The following cytokines will be measured: FN?, IL-1ß, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-22 and TNFa, 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
Secondary	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
Secondary	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