Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT03277040
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.2
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

Food is widely understood as a cornerstone of health, however multiple barriers stand between well-intentioned, well-informed consumers and the adoption of healthier dietary practices. This mixed-methods randomized controlled trial (RCT) will measure the impact of offering a Community Sustained Agriculture (CSA) share as an employee benefit on household food environments (diets), eating behaviors, and lifestyles.

Condition or Disease	Intervention/Treatment	Phase
Diet Habit; Obesity; Food Habits	Other: CSA membership	N/A

Detailed Description

Aim: We will test a strategy to increase frequency of cooking meals at home and consumption of healthful, fresh foods by providing study participants with a CSA membership.

Study design: This is a mixed method randomized controlled trial, with survey, home-food audit, and interview components.

Hypothesis: The intervention group who received a CSA membership as an employee benefit will prepare more meals at home and consume more healthful, fresh foods compared to the control group (no CSA participation).

Using both qualitative and quantitative assessments, outcomes will be measured using 3 primary measures:

1. Home food audits at baseline and at week 8 of the intervention. A random selection of participants will have home-food audits completed by members of the research team - those not randomly selected will complete the home-food audit themselves.

2. Self-administered surveys, including food frequency questionnaires, at baseline, week 8, and week 16.

3. Randomly selected participants will be asked to participate in qualitative interviews at the close of the 16-week intervention period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: DEAL Trial: Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives
• Actual Study Start Date: Sep 26, 2017
• Actual Primary Completion Date: Apr 10, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention (CSA membership) Employees will gain CSA membership - they will receive bi-weekly deliveries of fresh fruits and vegetables to a central location near their place of employment.	Other: CSA membership; Bi-weekly fresh food delivery
No Intervention: Control (no CSA membership) Usual care, usual employee benefits. Employees do not gain CSA membership.

Outcome Measures

Primary Outcome Measures

1. Quantity of meals prepared and consumed at home. [16 Weeks]

Secondary Outcome Measures

1. Self-reported satisfaction with employee benefits [16 Weeks]

2. Time spent planning meals [16 Weeks]

3. Time spent preparing meals [16 Weeks]

4. Perceived stress regarding food shopping, meal planning, and meal preparation [16 Weeks]

   Perceived stress regarding food shopping, meal planning, and meal preparation, assessed during follow-up qualitative interviews

5. Perceived stress regarding food shopping, meal planning, and meal preparation [16 Weeks]

   Perceived stress regarding food shopping, meal planning, and meal preparation, measured comparing baseline and follow-up surveys using likert scale questions

6. Knowledge and self-efficacy regarding healthy food preparation [16 Weeks]

   Knowledge and self-efficacy regarding healthy food preparation, assessed during follow-up qualitative interviews

7. Knowledge and self-efficacy regarding healthy food preparation [16 Weeks]

   Knowledge and self-efficacy regarding healthy food preparation, measured comparing baseline and follow-up surveys using likert scale questions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Individuals who are non-faculty employees at the University of Pennsylvania and University of Pennsylvania Health System.

• Individuals who score below the median (50th percentile) on dinners prepared at home on screening survey.

Exclusion Criteria:

• Individuals who are under the age of 18.

• Individuals who are already have a CSA membership.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carolyn Cannuscio, Assistant Professor of Family Medicine and Community Health, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03277040
• Other Study ID Numbers: 827780
• First Posted: Sep 8, 2017
• Last Update Posted: Feb 19, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 19, 2019