- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03783962
Examining Cooking as a Health Behavior (iChef)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A two arm randomized control trial will examine whether the addition of an active cooking lesson versus a passive observed lesson to a behavioral weight loss intervention results in significantly greater weight loss. Additionally, the study will examine whether interventions designed to promote cooking at home can increase participants' sense of food agency, and overcome common barriers to cooking at home such as time scarcity and budget constrictions.
Overweight and obese but otherwise healthy participants (n=64) will be recruited. Recruitment and study initiation will occur in two waves. Wave 1 aims to recruit 32 individuals who will then be randomized to 1) a 24 week, 24 session group behavioral weight loss intervention with 12 bi-weekly cooking lessons; or, 2) the same 24 week, 24 session group behavioral weight loss intervention with 12 bi-weekly cooking demonstrations. Both groups get the same intervention and the same counselor delivered intervention elements; the presence of active cooking lessons vs. passive observed cooking demonstrations is the only difference between conditions. Assessments will be conducted at 0, 3 and 6 months. Wave 2 (n=32) will follow the same process as Wave 1 approximately two months after Wave 1 is initiated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vermont
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Burlington, Vermont, United States, 05405
- University of Vermont
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- only individuals who are cooking (from scratch) no more than 3 meals at home per week will be eligible.
- must have a computer or smart device with internet access (at home or work) in order to track their diet and exercise behaviors,
- potential participants will be required to demonstrate some ability to comply with study intervention procedures to be eligible (specifically, they must complete an online dietary self-monitoring diary for 3 days)
- must be at least 18 years old and have a BMI between 25-50 kg/m2
- must agree to be randomized to either study arm and available for both scheduled meeting times in person on the University of Vermont campus
Exclusion Criteria:
- pregnant or planning to become pregnant in the next 6 months or lactating
- physical conditions that would preclude exercise
- medication affecting weight loss
- currently enrolled in another weight loss program
- currently cooking more than 3 meals from scratch at home per week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Active Intervention - Cooking
Twelve cooking classes will be run every other week after the in-person weight loss meetings.
These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss.
Classes will begin with a brief lecture on the day's topic, followed by a laboratory session.
Participants work in teams of two in the Nutrition and Food Sciences (NFS) foods lab to actively practice skills and cook a meal.
Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment.
Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.
|
Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress. Twelve cooking classes will be run every other week after the in-person weight loss meetings. |
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Active Comparator: Demonstrations - Cooking
The demonstration condition will serve as an "attention only" control.
Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to "even out" the time and attention devoted to the active cooking participants without introducing bias into the study design.
Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group.
All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class.
The demonstrations will be led by the same chef as the active intervention group.
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The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group.
The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Change
Time Frame: 24 weeks
|
Weight loss from baseline at 24 weeks
|
24 weeks
|
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Change From Baseline in the Total HEI Score, as a Measure of Diet Quality Change
Time Frame: Baseline and 24 weeks
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Difference in diet quality change between groups across assessments. 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:
Components are weighted equally and assigned a score of either 5 or 10. Scores as summed to determine total score. The minimum possible score is 0 and the maximum possible is 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 and 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cooking and Food Practices Change - Total Score
Time Frame: 24 weeks
|
Difference in baseline and end point Cooking and Food Provisioning Action Scale Total scores between groups. Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-21, higher scores over time indicate improvement. |
24 weeks
|
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Cooking and Food Practices Change - Structure Subscale
Time Frame: 24 weeks
|
Difference in baseline and end point Cooking and Food Provisioning Action Scale Structure subscale scores between groups. Structure subscale measures the ways in which external factors can either hinder or support an individual's cooking and provisioning actions. On a scale of 1-7, higher scores over time indicate improvement. |
24 weeks
|
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Cooking and Food Practices Change - Attitude Subscale
Time Frame: 24 weeks
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Difference in baseline and end point Cooking and Food Provisioning Action Scale Attitude subscale scores between groups. Structure subscale measures an individual's affective stance towards food, cooking and provisioning in different areas. On a scale of 1-7, higher scores over time indicate improvement. |
24 weeks
|
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Cooking and Food Practices Change - Self Efficacy Subscale
Time Frame: 24 weeks
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Difference in baseline and end point Cooking and Food Provisioning Action Scale Self Efficacy subscale scores between groups. Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-7, higher scores over time indicate improvement. |
24 weeks
|
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Cooking Frequency Change - Breakfast
Time Frame: 24 weeks
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Breakfast cooking frequency was assessed at baseline and 24 weeks 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.
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24 weeks
|
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Cooking Frequency Change - Lunch
Time Frame: 24 weeks
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Lunch cooking frequency was assessed at baseline and 24 weeks 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.
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24 weeks
|
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Cooking Frequency Change - Dinner
Time Frame: 24 weeks
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Dinner cooking frequency was assessed at baseline and 24 weeks 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.
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24 weeks
|
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Treatment Engagement- Attendance
Time Frame: 24 weeks
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Percent (of 24 possible) classes attended will be calculated to determine treatment engagement
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24 weeks
|
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Treatment Engagement- Food Journaling Compliance
Time Frame: Baseline to six months
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Percent of weekly food journals at least partially completed (an entry made during a seven day period) will be calculated to determine treatment engagement
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Baseline to six months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean R Harvey, PhD, RD, University of Vermont
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRBSS 19-0131
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.
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