NCT02941757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

October 12, 2016

Last Update Submit

July 13, 2020

Conditions

Diet, MediterraneanHealth BehaviorProgram SustainabilityProgram Effectiveness

Keywords

Mediterranean DietFirefightersworkplaceInterventionobesityRandomized Control Trial

Outcome Measures

Primary Outcomes (1)

  • Changes in Mediterranean diet scale

    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.

    6, 12, and 24 months

Secondary Outcomes (6)

  • Changes in BMI (m2/kg)

    24 months

  • Changes in weight (kg)

    24 months

  • Changes in waist circumference (cm)

    24 months

  • Changes in lipids

    24 months

  • Changes in inflammatory markers

    24 months

  • +1 more secondary outcomes

Study Arms (2)

Mediterranean Diet Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Mediterranean diet InterventionBEHAVIORAL

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.

Mediterranean Diet Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard TH Chan School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

  • Yang J, Farioli A, Korre M, Kales SN. Modified Mediterranean diet score and cardiovascular risk in a North American working population. PLoS One. 2014 Feb 4;9(2):e87539. doi: 10.1371/journal.pone.0087539. eCollection 2014.

    PMID: 24503596BACKGROUND

  • Yang J, Farioli A, Korre M, Kales SN. Dietary Preferences and Nutritional Information Needs Among Career Firefighters in the United States. Glob Adv Health Med. 2015 Jul;4(4):16-23. doi: 10.7453/gahmj.2015.050.

    PMID: 26331100BACKGROUND

  • What Is the Mediterranean Diet and How Can It Be Used to Promote Workplace Health? J Occup Environ Med. 2016 Mar;58(3):e111-3. doi: 10.1097/JOM.0000000000000681. No abstract available.

    PMID: 26949887BACKGROUND

  • Hershey MS, Chang CR, Sotos-Prieto M, Fernandez-Montero A, Cash SB, Christophi CA, Folta SC, Muegge C, Kleinschmidt V, Moffatt S, Mozaffarian D, Kales SN. Effect of a Nutrition Intervention on Mediterranean Diet Adherence Among Firefighters: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329147. doi: 10.1001/jamanetworkopen.2023.29147.

    PMID: 37589978DERIVED

  • Sotos-Prieto M, Cash SB, Christophi CA, Folta S, Moffatt S, Muegge C, Korre M, Mozaffarian D, Kales SN. Rationale and design of feeding America's bravest: Mediterranean diet-based intervention to change firefighters' eating habits and improve cardiovascular risk profiles. Contemp Clin Trials. 2017 Oct;61:101-107. doi: 10.1016/j.cct.2017.07.010. Epub 2017 Jul 11.

    PMID: 28710052DERIVED

Related Links

MeSH Terms

Conditions

Health BehaviorObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefanos N Kales, MD, MPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 21, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

US(1)