Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders
NCT ID: NCT05138198
Last Updated: 2021-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
62 participants
INTERVENTIONAL
2020-12-01
2021-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Mediterranean Diet & Physical Activity
Nutrition with a Physical Activity component. 10-week intervention implementing the Mediterranean Diet.
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
Usual care involves one-on-one monthly nutrition counseling
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PCL score: ≥40
* MOCA score: ≥22
* have a smartphone
* able to follow a diet intervention
* no physical disabilities which prevent exercising
Exclusion Criteria
* autoimmune disease
* history of surgical weight loss
40 Years
65 Years
ALL
No
Sponsors
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Stony Brook University
OTHER
Responsible Party
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Chrisa Arcan, PhD, MHS, MBA, RD
Assistant Professor
Locations
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World Trade Center Health Program Clinic
Commack, New York, United States
Countries
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Other Identifiers
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