Post-Traumatic Stress DisorderNCT05138198
Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders
A study testing Mediterranean Diet & Physical Activity in people with Post-Traumatic Stress Disorder and Overweight and Obesity, run by Stony Brook University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, Overweight and Obesity, Metabolic Syndrome
- What is being tested?
- Mediterranean Diet & Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- active cancer or history of GI-related cancer in the last 3 years
- autoimmune disease
- history of surgical weight loss
Trial locations and contacts
1 site in 1 country.
United States1 site
World Trade Center Health Program Clinic
Commack, New York, 11725
About this study
Official title: Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders With PTSD: Pilot Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Mediterranean Diet & Physical Activity, Usual Care
- Keywords
- Post-Traumatic Stress Disorder, Overweight and Obesity, Inflammation, Mediterranean Diet, Physical Activity, World Trade Center Responders, Metabolic Syndrome
- Medical subject headings
- Stress Disorders, Post-Traumatic, Overweight, Obesity, Metabolic Syndrome, Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet & Physical ActivityBehavioural
Also called Nutrition Intervention
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 CareBehavioural
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet & Physical Activity | Experimental | Nutrition with a Physical Activity component. 10-week intervention implementing the Mediterranean Diet. Receives: Behavioral: Mediterranean Diet & Physical Activity |
| Usual Care | Active comparator | Usual care involves one-on-one monthly nutrition counseling Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Secondary outcomes (12)
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.
Measured: 9 months
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
Measured: 9 months
Waist Circumference
Waist circumference is measured at baseline, post-intervention, and 3-month follow up.
Waist circumference cut off (Women>88cm; Men>102 cm)
Measured: 9 months
Total cholesterol
Total cholesterol is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 125 to 200mg/dL
Measured: 9 months
oxidized LDL
Serum oxLDL is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 10-170 ng/mL
Measured: 9 months
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)
Measured: 9 months
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 %
Measured: 9 months
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)
Measured: 9 months
HA1c
Serum Hemoglobin A1C (hA1C) is measured at baseline, post-intervention, and 3-month follow up.
hA1C: Normal: <5.7%
Measured: 9 months
Cytokines
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.
Measured: 6 months
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.
Measured: 9 months
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Dec 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrisa Arcan, PhD, MHS, MBA, RD, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138198
- Sponsor's protocol ID
- U01OH012057
- Status last verified
- Nov 2021
- First submitted
- 7 Aug 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders With PTSD: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05138198
- Acronym / sponsor ID
- U01OH012057
- Keywords
- Post-Traumatic Stress Disorder, Overweight and Obesity, Inflammation, Mediterranean Diet, Physical Activity, World Trade Center Responders, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet & Physical Activity | Experimental | Behavioral: Mediterranean Diet & Physical ActivityNutrition with a Physical Activity component. 10-week intervention implementing the Mediterranean Diet. |
| Usual Care | Active comparator | Behavioral: Usual CareUsual care involves one-on-one monthly nutrition counseling |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI range: 27-40
- PCL score: ≥40
- MOCA score: ≥22
- have a smartphone
- able to follow a diet intervention
Key exclusion criteria (3 listed)
- active cancer or history of GI-related cancer in the last 3 years
- autoimmune disease
- history of surgical weight loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean Diet & Physical ActivityAlso: Nutrition InterventionAt 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 | Behavioural | Mediterranean Diet & Physical Activity |
| Usual CareAlso: ControlAs 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. | Behavioural | Usual Care |
Primary outcome
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
12 secondary outcomes
Physical activity
Time frame: 9 months
Body mass index (BMI)
Time frame: 9 months
Waist Circumference
Time frame: 9 months
Total cholesterol
Time frame: 9 months
oxidized LDL
Time frame: 9 months
HDL cholesterol
Time frame: 9 months
Omega 3 fatty acid
Time frame: 9 months
Omega 6 to omega 3 ratio
Time frame: 9 months
HA1c
Time frame: 9 months
Cytokines
Time frame: 6 months
Psychosocial questionnaire
Time frame: 9 months
PCL score
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet & Physical Activity in people with Post-Traumatic Stress Disorder and Overweight and Obesity, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mediterranean diet score (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.