- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277040
Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives
DEAL Trial: Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Bi-weekly fresh food delivery
|
No Intervention: Control (no CSA membership)
Usual care, usual employee benefits.
Employees do not gain CSA membership.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quantity of meals prepared and consumed at home.
Time Frame: 16 Weeks
|
16 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported satisfaction with employee benefits
Time Frame: 16 Weeks
|
16 Weeks
|
|
Time spent planning meals
Time Frame: 16 Weeks
|
16 Weeks
|
|
Time spent preparing meals
Time Frame: 16 Weeks
|
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, assessed during follow-up qualitative interviews
|
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, measured comparing baseline and follow-up surveys using likert scale questions
|
16 Weeks
|
Knowledge and self-efficacy regarding healthy food preparation
Time Frame: 16 Weeks
|
Knowledge and self-efficacy regarding healthy food preparation, assessed during follow-up qualitative interviews
|
16 Weeks
|
Knowledge and self-efficacy regarding healthy food preparation
Time Frame: 16 Weeks
|
Knowledge and self-efficacy regarding healthy food preparation, measured comparing baseline and follow-up surveys using likert scale questions
|
16 Weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 827780
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on CSA membership
-
Dartmouth-Hitchcock Medical CenterNational Institute of Mental Health (NIMH)CompletedSchizophrenia | Schizoaffective Disorder | Bipolar DisorderUnited States
-
Dartmouth-Hitchcock Medical CenterCompletedSchizophrenia | Schizoaffective Disorder | Bipolar Disorder | Major Depressive DisorderUnited States
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Hamilton Health Sciences Corporation and other collaboratorsCompletedCerebrovascular AccidentCanada
-
Rush University Medical CenterCompletedHyperglycemia | Hypertension | Obesity | Overweight | Dyslipidemias | Depressive Symptoms | Metabolic Syndrome XUnited States
-
Shirley Ryan AbilityLabHonda R&D Americas, IncActive, not recruiting
-
Peking Union Medical College HospitalNot yet recruiting
-
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical...Completed
-
McMaster UniversityHamilton Health Sciences Corporation; Ontario Stroke NetworkCompleted
-
Institute of Hematology & Blood Diseases HospitalPeking University People's Hospital; Xiyuan Hospital of China Academy of Chinese... and other collaboratorsRecruitingRefractory Aplastic AnemiaChina
-
NYU Langone HealthRecruitingDiet HabitUnited States