- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05138198
Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders
Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders With PTSD: Pilot Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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New York
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Commack, New York, Stati Uniti, 11725
- World Trade Center Health Program Clinic
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Mediterranean Diet & Physical Activity
Nutrition with a Physical Activity component.
10-week intervention implementing the Mediterranean Diet.
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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.
Altri nomi:
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Comparatore attivo: Usual Care
Usual care involves one-on-one monthly nutrition counseling
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mediterranean diet score
Lasso di tempo: 9 months
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Physical activity
Lasso di tempo: 9 months
|
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.
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9 months
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Body mass index (BMI)
Lasso di tempo: 9 months
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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 |
9 months
|
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Waist Circumference
Lasso di tempo: 9 months
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Waist circumference is measured at baseline, post-intervention, and 3-month follow up. Waist circumference cut off (Women>88cm; Men>102 cm) |
9 months
|
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Total cholesterol
Lasso di tempo: 9 months
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Total cholesterol is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 125 to 200mg/dL
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9 months
|
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oxidized LDL
Lasso di tempo: 9 months
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Serum oxLDL is measured at baseline, post-intervention, and at 3-months follow-up; reference range: 10-170 ng/mL
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9 months
|
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HDL cholesterol
Lasso di tempo: 9 months
|
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) |
9 months
|
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Omega 3 fatty acid
Lasso di tempo: 9 months
|
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 % |
9 months
|
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Omega 6 to omega 3 ratio
Lasso di tempo: 9 months
|
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) |
9 months
|
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HA1c
Lasso di tempo: 9 months
|
Serum Hemoglobin A1C (hA1C) is measured at baseline, post-intervention, and 3-month follow up. hA1C: Normal: <5.7% |
9 months
|
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Cytokines
Lasso di tempo: 6 months
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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. |
6 months
|
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Psychosocial questionnaire
Lasso di tempo: 9 months
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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.
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9 months
|
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PCL score
Lasso di tempo: 9 months
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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
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9 months
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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Processi patologici
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Disturbi correlati a traumi e fattori di stress
- Resistenza all'insulina
- Iperinsulinismo
- Infiammazione
- Disturbi da stress, traumatici
- Disturbi da stress, post-traumatici
- Sindrome metabolica
- Sovrappeso
- Peso corporeo
Altri numeri di identificazione dello studio
- U01OH012057 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
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