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

NCT05138198 | Unknown DMC

• 1 other identifier: U01OH012057
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder; Overweight and Obesity; Metabolic Syndrome; Inflammation

Keywords

Post-Traumatic Stress Disorder; Overweight and Obesity; Inflammation; Mediterranean Diet; Physical Activity; World Trade Center Responders; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Physical activity

  9 months

• Body mass index (BMI)

  9 months

• Waist Circumference

  9 months

• Total cholesterol

  9 months

• oxidized LDL

  9 months

Study Arms (2)

Mediterranean Diet & Physical Activity

EXPERIMENTAL

Nutrition with a Physical Activity component. 10-week intervention implementing the Mediterranean Diet.

Behavioral: Mediterranean Diet & Physical Activity

Usual Care

ACTIVE COMPARATOR

Usual care involves one-on-one monthly nutrition counseling

Behavioral: Usual Care

Interventions

Mediterranean Diet & Physical Activity BEHAVIORAL

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

Also known as: Nutrition Intervention

Mediterranean Diet & Physical Activity

Usual Care BEHAVIORAL

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.

Also known as: Control

Usual Care

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

World Trade Center Health Program Clinic

Commack, New York, 11725, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Overweight; Obesity; Metabolic Syndrome; Inflammation; Motor Activity

Interventions

Diet, Mediterranean; Exercise; Diet Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: November 30, 2021
• Study Start: December 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

US (1)