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

Obesity Clinical Trial

Official title:

DEAL Trial: Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277040
• Other study ID #: 827780
• Status: Completed
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diet Habit
• Food Habits
• Obesity

Intervention

Other:
• CSA membership
Bi-weekly fresh food delivery

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of meals prepared and consumed at home.		16 Weeks
Secondary	Self-reported satisfaction with employee benefits		16 Weeks
Secondary	Time spent planning meals		16 Weeks
Secondary	Time spent preparing meals		16 Weeks
Secondary	Perceived stress regarding food shopping, meal planning, and meal preparation	Perceived stress regarding food shopping, meal planning, and meal preparation, assessed during follow-up qualitative interviews	16 Weeks
Secondary	Perceived stress regarding food shopping, meal planning, and meal preparation	Perceived stress regarding food shopping, meal planning, and meal preparation, measured comparing baseline and follow-up surveys using likert scale questions	16 Weeks
Secondary	Knowledge and self-efficacy regarding healthy food preparation	Knowledge and self-efficacy regarding healthy food preparation, assessed during follow-up qualitative interviews	16 Weeks
Secondary	Knowledge and self-efficacy regarding healthy food preparation	Knowledge and self-efficacy regarding healthy food preparation, measured comparing baseline and follow-up surveys using likert scale questions	16 Weeks