Clinical trial NCT05138198: Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders
Official title: Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders With PTSD: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mediterranean diet score
timeFrame: 9 months
Secondary outcomes:
measure: Physical activity
timeFrame: 9 months
measure: Body mass index (BMI)
timeFrame: 9 months
measure: Waist Circumference
timeFrame: 9 months
measure: Total cholesterol
timeFrame: 9 months
measure: oxidized LDL
timeFrame: 9 months
measure: HDL cholesterol
timeFrame: 9 months
measure: Omega 3 fatty acid
timeFrame: 9 months
measure: Omega 6 to omega 3 ratio
timeFrame: 9 months
measure: HA1c
timeFrame: 9 months
measure: Cytokines
timeFrame: 6 months
measure: Psychosocial questionnaire
timeFrame: 9 months
measure: PCL score
timeFrame: 9 months
Other outcomes:
Locations:
city: Commack
country: United States
facility: World Trade Center Health Program Clinic
state: New York
Study officials:
References: