Examining Cooking as a Health Behavior

Study Overview
=================
Brief Summary
-----------------
The proposed pilot study will examine cooking as an intervention target for weight control in overweight adults. The study will also 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. The study will utilize a cooking pedagogy designed to not just teach participants the basics of cooking different foods, but how to be efficient, mindful cooks. If cooking class participation positively impacts diet and health outcomes, it will bolster the case for promoting cooking at home as a health behavior for multiple populations.

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.

Official Title
-----------------
Examining Cooking as a Health Behavior

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Active Intervention - Cooking
* Behavioral: Demonstrations - Cooking


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Behavioral Weight Loss Program: Investigators have developed and implemented a theory-based group-delivered behavioral weight control program in two previous studies that incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. In addition to attending weekly classes, participants will track their food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on progress. The Cooking Program Active Intervention. Twelve cooking classes will be run every other week after the in-person weight loss meetings. Demonstrations. The demonstration condition will serve as an attention only control. All participants will 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Intervention - Cooking<br>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. | Behavioral: Active Intervention - Cooking<br>* 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.<br>|
| Active Comparator: Demonstrations - Cooking<br>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. | Behavioral: Demonstrations - Cooking<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change | Weight loss from baseline at 24 weeks | 24 weeks | 
| Change From Baseline in the Total HEI Score, as a Measure of Diet Quality Change | 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: 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. 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cooking and Food Practices Change - Total Score | 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 | 
| Cooking and Food Practices Change - Structure Subscale | 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 | 
| Cooking and Food Practices Change - Attitude Subscale | 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 | 
| Cooking and Food Practices Change - Self Efficacy Subscale | 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 | 
| Cooking Frequency Change - Breakfast | 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. | 24 weeks | 
| Cooking Frequency Change - Lunch | 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. | 24 weeks | 
| Cooking Frequency Change - Dinner | 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. | 24 weeks | 
| Treatment Engagement- Attendance | Percent (of 24 possible) classes attended will be calculated to determine treatment engagement | 24 weeks | 
| Treatment Engagement- Food Journaling Compliance | Percent of weekly food journals at least partially completed (an entry made during a seven day period) will be calculated to determine treatment engagement | Baseline to six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavioral weight loss intervention, obesity