Diet HabitNCT03277040
Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives
A study testing CSA membership in people with Diet Habit and Obesity, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Habit, Obesity, Food Habits
- What is being tested?
- CSA membership
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals who are under the age of 18.
- Individuals who are already have a CSA membership.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: DEAL Trial: Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives
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.
Read the 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:
- 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.
- Self-administered surveys, including food frequency questionnaires, at baseline, week 8, and week 16.
- Randomly selected participants will be asked to participate in qualitative interviews at the close of the 16-week intervention period.
- Conditions
- Diet Habit, Obesity, Food Habits
- Being tested
- CSA membership
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSA membershipOther
Bi-weekly fresh food delivery
| Study group | Role | What they receive |
|---|---|---|
| Intervention (CSA membership) | Experimental | 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. Receives: Other: CSA membership |
| Control (no CSA membership) | No intervention | Usual care, usual employee benefits. Employees do not gain CSA membership. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of meals prepared and consumed at home.
Measured: 16 Weeks
Secondary outcomes (7)
Self-reported satisfaction with employee benefits
Measured: 16 Weeks
Time spent planning meals
Measured: 16 Weeks
Time spent preparing meals
Measured: 16 Weeks
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
Measured: 16 Weeks
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
Measured: 16 Weeks
Knowledge and self-efficacy regarding healthy food preparation
Knowledge and self-efficacy regarding healthy food preparation, assessed during follow-up qualitative interviews
Measured: 16 Weeks
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
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start26 Sep 2017
- Primary completion10 Apr 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Cannuscio, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277040
- Sponsor's protocol ID
- 827780
- Status last verified
- Feb 2019
- First submitted
- 6 Sep 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feuerstein-Simon R, Dupuis R, Schumacher R, Cannuscio CC. A Randomized Trial to Encourage Healthy Eating Through Workplace Delivery of Fresh Food. Am J Health Promot. 2020 Mar;34(3):269-276. doi: 10.1177/0890117119890804. Epub 2019 Dec 16.
PubMed 31840522
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEAL Trial: Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives
- ClinicalTrials.gov ID
- NCT03277040
- Acronym / sponsor ID
- 827780
- Conditions
- Diet Habit, Obesity, Food Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Self-administered surveys, including food frequency questionnaires, at baseline, week 8, and week 16.
- Randomly selected participants will be asked to participate in qualitative interviews at the close of the 16-week intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (CSA membership) | Experimental | Other: CSA membershipEmployees will gain CSA membership - they will receive bi-weekly deliveries of fresh fruits and vegetables to a central location near their place of employment. |
| Control (no CSA membership) | No intervention | –Usual care, usual employee benefits. Employees do not gain CSA membership. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals who are under the age of 18.
- Individuals who are already have a CSA membership.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSA membershipBi-weekly fresh food delivery | Other | Intervention (CSA membership) |
Primary outcome
Quantity of meals prepared and consumed at home.
Time frame: 16 Weeks
7 secondary outcomes
Self-reported satisfaction with employee benefits
Time frame: 16 Weeks
Time spent planning meals
Time frame: 16 Weeks
Time spent preparing meals
Time frame: 16 Weeks
Perceived stress regarding food shopping, meal planning, and meal preparation
Time frame: 16 Weeks
Perceived stress regarding food shopping, meal planning, and meal preparation
Time frame: 16 Weeks
Knowledge and self-efficacy regarding healthy food preparation
Time frame: 16 Weeks
Knowledge and self-efficacy regarding healthy food preparation
Time frame: 16 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 31840522Feuerstein-Simon R, Dupuis R, Schumacher R, Cannuscio CC. A Randomized Trial to Encourage Healthy Eating Through Workplace Delivery of Fresh Food. Am J Health Promot. 2020 Mar;34(3):269-276. doi: 10.1177/0890117119890804. Epub 2019 Dec 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSA membership in people with Diet Habit and Obesity, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of meals prepared and consumed at home. (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03277040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.