Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders With PTSD: Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Stony Brook University
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Mediterranean diet score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Mediterranean diet score
Time Frame: 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 Outcomes
- Omega 6 to omega 3 ratio(9 months)
- HA1c(9 months)
- Cytokines(6 months)
- Psychosocial questionnaire(9 months)
- PCL score(9 months)
- Physical activity(9 months)
- Body mass index (BMI)(9 months)
- Waist Circumference(9 months)
- Total cholesterol(9 months)
- oxidized LDL(9 months)
- HDL cholesterol(9 months)
- Omega 3 fatty acid(9 months)
Investigators
Chrisa Arcan, PhD, MHS, MBA, RD
Assistant Professor
Stony Brook University