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Feeding America's Bravest: Mediterranean Diet-Based Interventions to Change Firefighters' Eating Habits

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ClinicalTrials.gov Identifier: NCT02941757
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
National Institute for Public Safety Health, Indianapolis
Tufts University
U.S Department of Homeland Security; Assistance to Firefighters Grants
Information provided by (Responsible Party):
Kales Stefanos, Harvard School of Public Health

Brief Summary:
The purpose of this study is to modify the food culture of the fire service by motivating firefighters and their families to incorporate Mediterranean diet principles at work and home through behavior change strategies that involve education, participation and incentives. The ultimate purpose is to lower firefighters' risks for CVD and cancer by successfully getting more firefighters and their families to adopt and incorporate the healthy eating principles behind the Mediterranean diet.

Condition or disease Intervention/treatment Phase
Diet, Mediterranean Health Behavior Program Sustainability Program Effectiveness Behavioral: Mediterranean diet Intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feeding America's Bravest: Mediterranean Diet-Based Interventions to Change Firefighters' Eating Habits and Improve Cardiovascular Risk Profiles
Study Start Date : October 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Mediterranean Diet Intervention group
In phase I, Group 1 will receive the MDNI for 12-months. Phase II: Group 1 fire houses will cross-over to "self-sustained continuation," a less intense, self-directed, maintenance phase for 12 months to examine longer-term persistence of behavior change after the active 12-month MDNI. During self-sustained continuation access to some environmental changes: such as discounted food access, peer education/support, and online learning will remain; however, the stations will not receive investigator-led educational sessions
Behavioral: Mediterranean diet Intervention
  1. Educational materials (online learning) will be provided via the study website; group educational sessions and written materials (brochure with Mediterranean Diet recommendations, shopping list recommendations and sample recipes, specific Mediterranean Diet Pyramid; videos; educational sessions; in-person chef-led, Mediterranean cooking demonstrations.
  2. Peer-education and support
  3. Discounted food access: The investigators have partnered with Kroger supermarkets, a large national chain with numerous stores in the Indianapolis area, to provide discounted access to key Mediterranean foods for both participating firefighters and their families.
  4. Email or text message encouragement and reminders during the intervention.

No Intervention: Control group
2) In phase I, Group 2 will receive usual care, consisting of existing IFD health and wellness activities, with no investigator-provided interventions. In Phase II, Group 2 fire houses will cross-over to receive the full active MDNI for 6 months. The Group 2 MDNI will test the efficacy of a shorter, but otherwise identical MDNI. It will be followed by a final 6 months of "self-sustained continuation" (as described above) to examine the shorter MDNI's effect on persistence of adherence.



Primary Outcome Measures :
  1. Changes in Mediterranean diet scale [ Time Frame: 6, 12, and 24 months ]
    12 months change in the MD scores as well as 12- and 24 month change in group 1; and 6 and 12 month change from baseline to follow up in group 2.


Secondary Outcome Measures :
  1. Changes in BMI (m2/kg) [ Time Frame: 24 months ]
  2. Changes in weight (kg) [ Time Frame: 24 months ]
  3. Changes in waist circumference (cm) [ Time Frame: 24 months ]
  4. Changes in lipids [ Time Frame: 24 months ]
    LDL (mg/dl), HDL (mg/dl), total cholesterol

  5. Changes in inflammatory markers [ Time Frame: 24 months ]
    CRP (mg/L)

  6. Changes in biomarkers [ Time Frame: 6 months ]
    (Tyrosol, hydroxytyrosol, and plasma fatty acids)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • those permanently assigned to one of the 45 IFD stations
  • with a fire department-provided medical exam in the last two years
  • at least 18 years of age
  • full duty status at the time of consent

Exclusion Criteria:

  • those without a recorded fire department exam in the last two years
  • less than 18 years of age
  • restrictions on duty at the time of consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941757


Contacts
Contact: Carolyn M Muegge, MS, MPH 3179642362 carolyn.muegge@nipsh.org
Contact: Mercedes Sotos Prieto, PhD 6178608979 msotosp@hsph.harvard.edu

Locations
United States, Massachusetts
Harvard TH Chan School of Public Health Recruiting
Boston, Massachusetts, United States, 02115
Contact: Stefanos N Kales, MD, MPH    617-665-1580    skales@hsph.harvard.edu   
Contact: Mercedes Sotos Prieto, PhD    6178608979    msotosp@hsph.harvard.edu   
Sub-Investigator: Mercedes Sotos Prieto, PhD         
Sponsors and Collaborators
Harvard School of Public Health
National Institute for Public Safety Health, Indianapolis
Tufts University
U.S Department of Homeland Security; Assistance to Firefighters Grants
Investigators
Principal Investigator: Stefanos N Kales, MD, MPH Harvard School of Public Health

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kales Stefanos, Associate Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02941757     History of Changes
Other Study ID Numbers: EMW-2014-FP-00612
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Keywords provided by Kales Stefanos, Harvard School of Public Health:
Mediterranean Diet
Firefighters
workplace
Intervention
obesity
Randomized Control Trial