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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04084028
Other study ID # CHRBSS #00000397
Secondary ID VT-H02510
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date May 18, 2020

Study information

Verified date June 2021
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Students who live off campus at the University of Vermont will be recruited to participate in the study which will begin in Fall 2019 and run through May 2020. The intervention is a randomized-controlled trial where students will be randomized into one of four conditions: 1) Active cooking classes followed by meal kits and recipes, 2) Active cooking classes followed by no further instruction, 3) No cooking classes followed by meal kits and recipes, or 4) No intervention. Assessments will be conducted at baseline and following each phase.


Description:

The proposed pilot study is a randomized trial to evaluate whether cooking classes produce greater gains in cooking skills, food agency, and cooking frequency than meal kits or no intervention. There will be three phases to the study intervention and four study conditions (as outlined below). Phase 1- Cooking classes. All participants will attend 1 kitchen intensive session followed by 1 cooking class per week for 6 weeks Phase 2- Meal Kits. Assigned participants will receive meal kit deliveries once per week for 6 weeks. Phase 3- Recipes. Assigned participants will receive 5 healthy recipes by email once per week for 6 weeks. This phase was planned, but was canceled due to disruptions caused by the COVID-19 outbreak. The investigators will randomize 64 students to one of four intervention conditions. Group A (n=16) - Active cooking classes followed by meal kits and recipes Group B (n=16) - Active cooking classes followed by no further instruction Group C (n=16) - No cooking classes followed by meal kits and recipes Group D (n=16) - No intervention Assessments will be conducted at baseline, and following each phase. Cooking Classes: Subjects in the cooking class conditions will begin with a brief lecture on the day's lesson followed by a demonstration from the chef instructor. Subjects will then work with a partner to prepare the recipe with guidance from the chef instructor. All participants will receive printed copies of the weekly recipe(s). At the end of the class period all subjects will take part in a sensory experience led by the chef instructor in which they will observe the appearance, smell, taste, and texture, of the meal they have just prepared. Meal Kits: With the meal delivery service, participants will get all the ingredients they need to make a meal as well as a recipe for the meal which includes step-by-step photos. They are then responsible for doing the actual cooking of the meal. Students will all receive kits for 3 meals per week from the same delivery service and will have the option to select meals that fit their dietary needs (vegetarian, gluten free, etc.). Meal kits are designed to serve two individuals therefore students should have enough food for six meals, though they will only need to cook three times. The service used is open to the public, therefore students who enjoyed the meal kit service could opt to continue service and pay for it themselves. However, students will be instructed to wait until study completion to do so. Recipes: Recipes will be designed by the research team, which includes three registered dietitians and a trained chef. Students will receive recipes for five healthy meals per week. Participants will need to shop, budget, and plan on their own. Recipes will accommodate major dietary preferences including vegetarian and gluten-free.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date May 18, 2020
Est. primary completion date May 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Undergraduate students at the University of Vermont living off campus independently (may have roommates but not live with a guardian) - Ages 18-25 - Cooks dinner at home no more than 3x/week - Access to a kitchen at home - Availability during scheduled cooking classes/demonstrations Exclusion Criteria: - Students will be excluded from the study if they do not complete baseline data collection measures prior to the first class meeting.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Active Cooking Classes
6 cooking classes will be held every week for 6 consecutive weeks. The lessons are patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for those cooking for themselves for the first time. Classes begin with a brief lecture on the day's topic. Students will work in teams of 2 in the foods lab to actively practice skills and cook a meal. Students receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. All students attend a 2 hour kitchen intensive demonstration as an orientation.
Meal Kits
Students receive 6 weeks of home delivered meal kits. Meal kits include ingredients and detailed instructions for 3 meals, which each serve two people. Students may select meals from a list of 18 options that include vegan, vegetarian, and gluten free options.
Recipes
Students are emailed a set of recipes once a week for 6 weeks. Recipes include options for breakfast, lunch, dinner, and snacks. Recipe sets include vegan, vegetarian, and gluten-free options. This intervention was cancelled by COVID-related disruptions and did not take place.

Locations

Country Name City State
United States University of Vermont Burlington Vermont

Sponsors (1)

Lead Sponsor Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diet Quality at Baseline and Change From Baseline Difference in diet quality change between groups from baseline, end of phase 1, and end of phase 2. Measured by Healthy Eating Index scores.
The HEI includes 13 components that capture recommendations of the 2015-2020 Dietary Guidelines for Americans. There are two groupings of components:
Adequacy components are encouraged. Higher scores reflect higher intakes.
Moderation components should be limited. Higher scores reflect lower intakes. A higher total HEI score reflects higher diet quality as defined by the Dietary Guidelines for Americans.
Components are weighted equally and assigned a score of either 5 or 10. Scores as summed to determine total score. Score range is 0 - 100.
Adequacy Components:
Total Fruits 5 Whole Fruits 5 Total vegetables 5 Greens and beans 5 Whole grains 10 Dairy 10 Total protein foods 5 Seafood and plant proteins 5 Fatty acids 10
Moderation Components:
Refined grains 10 Sodium 10 Added sugars 10 Saturated fats 10
Baseline, end of phase 1, and end of phase 2, up to 12 weeks
Secondary Cooking and Food Practices at Baseline and Change From Baseline Cooking and Food Practices score at baseline and change at phase 1 and phase 2, will be measured by The Cooking and Food Provisioning Action Scale (CAFPAS) measures food preparation skills and capacities. The CAFPAS contains 28 items administered with a 7-point bipolar Likert scale. There are three subscales: Self-Efficacy (measures whether an individual thinks their cooking ability and skills are adequate), Attitude (measures an individual's affective stance towards food, cooking and provisioning in different areas), and Structure (measures the ways in which external factors can either hinder or support an individual's cooking and provisioning actions). Subscales are scored by coding responses from 1-7, reversing them as necessary, summing the items and dividing by the standard deviation of the sample population's scores on the subscale. The total CAFPAS score is the sum of the three subscales. The total score range is 3-196. A higher score is associated with improvement. Baseline, end of phase 1, and end of phase 2, up to 12 weeks
Secondary Stress Level at Baseline and Change From Baseline The Perceived Stress Scale is a reliable and valid measure of perceived stress in adults including college students. Ten questions assess how often one perceives various forms of stress such as feeling unable to control important events, being upset by something unexpected, and feeling nervous. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress
Baseline, end of phase 1, and end of phase 2, up to 12 weeks
Secondary Breakfast Cooking Frequency at Baseline and Change From Baseline Breakfast cooking frequency was assessed at baseline and following each 6 week study phase using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period. Baseline, end of phase 1, and end of phase 2, up to 12 weeks
Secondary Lunch Cooking Frequency at Baseline and Change From Baseline Lunch cooking frequency was assessed at baseline and following each 6 week study phase using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period. Baseline, end of phase 1, and end of phase 2, up to 12 weeks
Secondary Dinner Cooking Frequency at Baseline and Change From Baseline Dinner cooking frequency was assessed at baseline and following each 6 week study phase using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period. Baseline, end of phase 1, and end of phase 2, up to 12 weeks
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