NCT03806868

Brief Summary

This Dietary Intervention is being done to evaluate the feasibility of a food voucher program and dietary counseling to increase consumption of healthy fatty acids (omega-3) in individuals with Chronic Obstructive Pulmonary Disease (COPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

January 23, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

January 14, 2019

Last Update Submit

March 2, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

  • Change in serum omega 3 levels

    Omega 3 levels in serum (mg) will be measured at each study visit.

    Baseline, 2 weeks and 4 weeks

  • Change in omega 3 intake

    A food frequency questionnaire will be administered at baseline and 4 weeks after randomization to estimate omega 3 intake (mg) at each study visit

    Baseline and 4 weeks

Secondary Outcomes (4)

  • Change in health status as assessed by the Clinical COPD Questionnaire (CCQ)

    Baseline, 2 weeks and 4 weeks

  • Change in the Cough and Sputum Assessment Questionnaire (CASA-Q) Score

    Baseline, 2 weeks and 4 weeks

  • Change in Functional status (CAT)

    Baseline, 2 weeks and 4 weeks

  • Change in FEV1 percentage predicted

    Baseline, 2 weeks and 4 weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The Intervention group will receive a voucher for ordering foods (ONLY omega-3 rich foods) weekly (4 times).

Other: voucher for ordering foods (ONLY omega-3 rich foods)

Control group

SHAM COMPARATOR

The Control group will receive a voucher for ordering foods in general (any type of foods) weekly (4 times). Participants will NOT be limited to purchasing foods rich in omega-3.

Other: voucher for ordering foods in general (any type of foods)

Interventions

voucher for ordering foods (ONLY omega-3 rich foods)OTHER

A voucher will be provided weekly (4 times) for ordering only omega-3 rich foods. Groceries will be delivered to participants' home weekly.

Intervention group
voucher for ordering foods in general (any type of foods)OTHER

A voucher will be provided weekly (4 times) for ordering any type of food. Groceries will be delivered to participants' home weekly.

Control group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 40 years,
  • Physician diagnosis of COPD, Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced -Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) \<70% and FEV1 (% predicted) \<80%,
  • Tobacco exposure ≥ 10 pack-years
  • Former smoker with an exhaled Carbon Monoxide (eCO)\<=6 ppm to confirm smoking status
  • No home smoking ban.
  • Subjects with low omega-3 intake (EPA+DHA levels \<500mg) based on data extracted from a food frequency questionnaire (FFQ) completed before the randomization.

You may not qualify if:

  • Chronic systemic corticosteroids,
  • Other chronic lung disease including asthma,
  • Living in location other than home (e.g., long term care facility)
  • Homeowner or occupant planning to move or change residence within study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • NADIA NATHALIE HANSEL

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 16, 2019

Study Start

January 23, 2019

Primary Completion

February 14, 2020

Study Completion

February 21, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)