Examining Cooking as a Health Behavior
Phase: NA
Conditions: Obesity
Sponsor: University of Vermont

HS Protocol Form 7/14/17
Human Subjects Research Protocol 
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be completed for any human subjects research proposal that does not have a specific “protocol,” such as a grant application.  
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consistent with that proposal.  This protocol form, once IRB approved, will be the working protocol for that research.  When 
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PROTOCOL SUMMARY
Project Title:
Protocol Version Date:
Examining Cooking as a Health Behavior 
6-14-19
Principal Investigator:  
Jean Harvey PhD, RD
Grant Sponsor:
USDA Hatch Act Funds
Grant  Number:
VT-H02510
                                                                                              (For grants routed through UVM, indicate the OSP Proposal ID #
                                                                                                 located at the top of the OSP Routing Form)
Lay Language Summary:  (Please use non-technical language that would be understood by nonscientific IRB members to 
summarize the proposed research project.  The information must include: (1) a brief statement of the problem and related 
theory supporting the intent of the study, and (2) a brief but specific description of the procedure(s) involving the human 
subjects.  Please do not exceed one single-spaced 8 ½ X 11” page.)
With the rise in obesity in America correlating strongly with the decline in the frequency that Americans cook at
home, cooking may be an important behavior to encourage to promote health. Increasing the prevalence of Americans who 
cook meals at home may be an important health behavior to target, because cooking at home is widely regarded as being 
healthier than consuming food away from home.  While interventions are limited in number and scope, the positive benefits of 
cooking at home on dietary quality seem to cut across age groups and populations from college students to older adults.6, 
7Cooking classes may be an important intervention target because they may increase one’s food agency.  Thinking of cooking 
as a health behavior, cooking classes may be equivalent to exercise classes for someone trying to increase their physical 
activity.  The exercise classes give one the skills, social structure, and self-efficacy to begin exercising on one’s own.  This 
study is designed to test whether cooking classes could do the same for someone’s food agency and cooking frequency.  
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 
we find that cooking class participation positively impacts diet and health outcomes, we will bolster the case for promoting 
cooking at home as a health behavior for multiple populations.
The study aims to recruit 64 overweight or obese adults to participate in a 24-week 2 part weight loss intervention. The 
intervention will include a weekly in-person behavioral weight control program and a bi-weekly cooking class. Each participant 
will be assigned to either the treatment group which will receive active cooking lessons or the control group which will receive 
demonstration only cooking lessons. Assessments including anthropometric measures and questionnaire data will be collected 
at baseline and week 24.
Aim 1: To determine if the addition of cooking classes to a behavioral weight control intervention improves weight loss and diet 
quality in overweight and obese adults.
Aim 2: To evaluate changes in food agency, cooking perceptions, and cooking frequency for individuals participating in the 
COOKING versus DEMONSTRATION conditions. 
Weight Control Program: We 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,37-39 including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making 
sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-
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person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group 
sessions over 6 months. Target weight losses of 10% of baseline weight are promoted. Behavioral strategies are drawn from 
social cognitive theory40 and self-regulation theory41 and mirror the core components incorporated into such successful 
programs as Look AHEAD.42
Cooking Classes: 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. 
PURPOSE AND OBJECTIVES  
Purpose:  The importance of the research and the potential knowledge to be gained should be explained in detail.  Give 
background information. 
Frequency and Importance of Cooking at Home
Over the last twenty years Americans’ eating habits have shifted, with fewer meals cooked at home and more meals eaten 
outside the home from restaurants, convenience stores, fast food locations, and cafeterias.1-3 The latest analysis by the United 
States Department of Agriculture (USDA) Economic Research Service (ERS) indicated that household expenditures on food 
away from home have been steadily increasing over time and reached 43.7% of food expenditures in 2014.4 As a percent of 
total household income, food away from home accounted for 5.4% of disposable income in 2014. Because food away from 
home is typically far less healthy5-9 than food eaten at home, it is no surprise that many public health interventions have 
focused on attempting to make meals away from home healthier. However, Americans still report spending more of their 
disposable income on food eaten at home (6%), and at least 90% report at least sometimes cooking at home10. Regardless, it 
is clear that with innumerable options available to outsource cooking, this once necessary domestic behavior has declined in 
recent years in step with the rise of convenience food consumption.11 In fact, the decline in cooking has been cited as being 
responsible for the increase in the prevalence of obesity and other chronic disease risk factors.12 Despite this, few interventions 
have focused on overcoming the barriers people face to cooking more frequently at home and helping people cook healthy 
meals at home.3 
Increasing the prevalence of Americans who cook meals at home may be an important health behavior to target, because 
cooking at home is widely regarded as being healthier than consuming food away from home. While interventions are limited in 
number and scope, the positive benefits of cooking at home on dietary quality seem to cut across age groups and populations 
from college students to older adults.6,7 A study by Wolfson et al., looking at data from the National Health and Nutrition 
Examination Survey found that adults who cook dinner frequently at home had diets lower in total energy, fat, and sugar than 
those who cooked less frequently at home.13 This association between cooking dinner more frequently at home and a healthier 
diet was present regardless of whether someone was actively attempting to lose weight or not.13 Additional research from the 
USDA ERS has also found that food prepared at home is of higher dietary quality than food prepared away from home, with 
food prepared away from home associated with diets higher in calories, saturated fat, added sugars, and lower in fruits, 
vegetables, and whole grains.8, 9 In addition to research associating cooking at home with better diet quality, there is also 
evidence that increasing one’s cooking knowledge and/or skill is associated with increased healthy food intake.14, 15 Finally, 
some research has associated cooking at home with lower Body Mass Index (BMI).16 Despite all of the evidence indicating that 
cooking at home should be considered a health behavior, several studies have found that cooking at home is not associated 
with diet quality or BMI benefits,17,18 indicating that learning how to cook healthfully at home may be essential for positive health 
benefits.
In addition to any potential benefits on dietary quality and weight status, it may be the case that cooking positively impacts 
social and emotional health.6 In a survey of young adults, Larson et al., found that eating dinner with others versus eating on 
the run was associated with higher intakes of fruits and vegetables, and that the majority of young adults surveyed wanted to 
eat with others, but reported not having enough time.19 Cooking ability has also been linked to lower depressive symptoms, and 
higher mental well-being in adolescents, while participation in a culinary intervention was associated with greater quality of life 
in adults.20,21 In a review of the literature surrounding cooking and health, Mills et al. even found some evidence that2 cooking 
could have positive benefits on cultural identity and personal relationships.22 All of these findings build the case that cooking at 
home may impart benefits beyond improving one’s diet or weight. 
Barriers to Cooking at Home
There are a variety of societal and technological shifts since the 1960’s that are often cited as reasons
for why Americans cook less frequently at home, such as a notable increase in women joining the workforce, advances in food 
technology, and mass food preparation.5 However, on an individual basis, issues such as lack of cooking knowledge, restricted 
access to healthy foods, economic constraints, and time scarcity have all been cited as potential factors for the decline in home 
cooking frequency.5,23,24 Time scarcity is a fascinating concept to consider as a barrier for cooking at home, as there have 
always been and will always be 24 hours in a day. Therefore, it’s not that Americans today have less total time than Americans 
in the 1960’s, but that they choose to, or need to, spend that time differently, and feel that tasks like cooking can be shortened 
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or offloaded to preserve time for other activities.23 Time scarcity seems to be a cooking barrier for many populations. Many 
parents report that time scarcity is a barrier to providing healthy meals, and that they often resort to using convenience foods 
and picking up take out to feed their families.25 A longitudinal analysis of Australian adults indicated that time scarcity was 
associated with eating out more, less fruit and vegetable consumption, and higher intakes of discretionary calories.22 Economic 
analyses have also indicated that time scarcity is associated with increased intake of fast food.26 Although much work has 
illustrated that many people feel that they cannot engage in health behaviors such as cooking because of perceived or actual 
time scarcity,22,23 very few intervention studies have examined potential strategies that might decrease people’s perceptions of 
time scarcity and increase the number of days they are willing to cook meals at home.
Encouraging Cooking at Home
While cooking has been associated with a number of positive nutrition and health outcomes, current cooking interventions 
suffer from a number of methodological limitations.27 In many, cooking skills or cooking “classes” are rarely presented as a sole 
component in interventions but are combined with nutrition, exercise, mindfulness, parenting, etc. topics.28 It’s not clear then if 
cooking has value alone or just in concert with other treatment components. Current cooking interventions are also quite 
variable in length; 6-10 weeks of weekly sessions with 90-120 minutes devoted to class. Interventions also differ substantially in 
the level of engagement participants have with hands on cooking; some simply observe skills while others practice skills and 
create full meals. Finally, most evaluations of cooking interventions have relied on self-report measures that are rarely 
validated, thus calling into question the many positive outcomes cited above.29 A more robust approach to evaluation is 
desperately needed. 
Overweight women may be especially motivated to learn about and engage in cooking behaviors. Women are often the 
“gatekeeper” of a family’s meal and food life, so improving their cooking knowledge and skill may have a ripple effect for the 
entire family.30 Ready-to-eat, convenience and restaurant foods are often significantly higher in calories, fat, salt and sugar than 
whole, home-prepared foods,8 yet current state-of-the-art obesity treatment programs do not address cooking or home food 
preparation skills at all. To our knowledge, there has never been a weight management intervention that includes and isolates a 
cooking intervention. Adding cooking as a health behavior to a well-proven behavioral obesity treatment may improve weight 
loss, weight maintenance and diet quality. Obesity remains the greatest public health crisis of3 our time. Developing skills to 
facilitate and enhance weight management could have significant public health impact.
Cooking classes may be an advantageous way to address many barriers to cooking. Cooking classes can impact time poverty 
by helping participants learn how to plan meals and easily prepare ingredients.5 They may also teach budgeting skills to 
address economic barriers. However, very few rigorous studies have been conducted that design and evaluate cooking 
interventions in any adult population.7 A 2018 review by Hollywood and colleagues31 evaluated the behavior change techniques 
used in cooking interventions that were most likely to result in long-term behavior change. Fifty-nine cooking and food skills 
interventions were identified by two systematic reviews. Only 24 interventions included practical cooking sessions to develop 
cooking skills while all others were based on wider food skills like nutrition knowledge and budgeting. Of the 24 cooking 
interventions, only 12 were randomized controlled trials. Of those reporting a long-term behavior change (greater than 3 
months; n=14), the majority included a “practical skills element” and information on “how to carry out the task” versus just a 
demonstration of the task. This suggests that food demonstrations are not sufficient to encourage behavior change. The 
authors also concluded that the vast majority of outcome measures relied on self-report thus, results are to be interpreted with 
caution.
Fostering Food Agency
Cooking classes may be an important intervention target because they may increase one’s food agency. Thinking of cooking as 
a health behavior, cooking classes may be equivalent to exercise classes for someone trying to increase their physical activity. 
The exercise classes give one the skills, social structure, and self-efficacy to begin exercising on one’s own. This study is 
designed to test whether cooking classes could do the same for someone’s food agency and cooking frequency. Food agency 
looks at cooking as more than just a manual skill, it takes into account the sensory, socio-cultural (e.g. time, money) and 
physical environments involved in cooking, and it incorporates the ability to adapt. Those with high food agency feel 
empowered in their cooking practice, as they have the planning and preparatory skills, as well as the cooking skills to be 
successful.32 Trubek et al., have developed a pedagogy for cooking classes designed to increase food agency by addressing 
the cognitive, technical, and mechanical skills necessary to make a meal.27, 32 By using pedagogy designed to increase one’s 
food agency, the participant is better prepared to overcome potential daily challenges that could prevent them from meeting 
their cooking, nutrition, and social goals. The pedagogy emphasizes not just skill building like how to read and use a recipe, but 
adaptability and the development of decision-making and organizational skills that will be helpful no matter the food 
environment, time, or resource limitations.28 The concept of food agency views cooking behavior in a more holistic way. It is not 
enough to just teach someone the mechanics of cooking, in order for cooking to become an ingrained practice, you must teach 
someone how to overcome barriers and adapt to the conditions they face in daily life. Like many other health behaviors, 
encouraging someone to cook will only be successful if that person feels empowered to take the practice and apply it in their 
own life to form a habit.
Increasing Motivation to Adopt Cooking as a Health Behavior
Along with teaching cooking competency through a pedagogy that emphasizes food agency, it may be helpful to provide a 
material incentive to help overcome remaining barriers to healthy cooking. Incentives have been deployed successfully for a 
variety of health behaviors and health outcomes such as exercise and weight loss.33,34 Incentives can be offered in many forms, 
on a variety of schedules, and in various amounts. As provisioning food, deciding what to buy, and having the resources to buy 
it, are often cited as barriers to cooking at home, it may be the case that providing people with meals and/or recipes each week 
could serve as incentives to overcome the provisioning barrier and encourage people to implement the skills learned during 
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their cooking classes. Recently, meal kit delivery services such as Hello Fresh, Blue Apron, and Purple Carrot have risen in 
popularity.35 These services provide subscribers with the raw ingredients in the correct amounts necessary to make particular 
recipes and then also provide the recipes. Previous research has shown that providing participants with food increases their 
weight loss,36 but there is very little research indicating if providing food has a positive impact on cooking behavior or diet 
quality.
Summary
The current study will expand on previous research surrounding the efficacy of employing cooking classes to build cooking 
skills, foster food agency, and improve dietary behaviors by employing a rigorous randomized controlled trial design and 
validated outcome measures in overweight or obese adults. The overall goal is to determine if encouraging cooking as a health 
behavior actually improves health outcomes.
References. Include references to prior human or animal research and references that are relevant to the design and conduct 
of the study.
References
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Smith LP, Ng SW, Popkin BM. Trends in US home food preparation and consumption: analysis of national nutrition 
surveys and time use studies from 1965–1966 to 2007–2008. Nutrition Journal. 2013;12:45.
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Service USDoAER. Table 10 - Food away from home as a share of food expenditures. In: Agriculture USDo, ed2016.
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Agriculture ERS, edJuly 2016.
12. Seguin RA, Aggarwal A, Vermeylen F, Drewnowski A. Consumption Frequency of Foods Away from Home Linked 
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14. Hartmann C, Dohle S, Siegrist M. Importance of cooking skills for balanced food choices. Appetite. 2013;65:125-131.
15. Brown BJ, Hermann JR. Cooking classes increase fruit and vegetable intake and food safety behaviors in youth and 
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17. García-González Á, Achón M, Alonso-Aperte E, Varela-Moreiras G. Identifying Factors Related to Food Agency: 
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18. Ducrot P, Fassier P, Méjean C, Allès B, Hercberg S, Péneau S. Association between motives for dish choices during 
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19. Larson NI, Nelson MC, Neumark-Sztainer D, Story M, Hannan PJ. Making time for meals: meal structure and 
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20. Utter J, Denny S, Lucassen M, Dyson B. Adolescent cooking abilities and behaviors: Associations with nutrition and 
emotional well-being. Journal of nutrition education and behavior. 2016;48:35-41. e31.
21. Barak-Nahum A, Haim LB, Ginzburg K. When life gives you lemons: The effectiveness of culinary group intervention 
among cancer patients. Social Science & Medicine. 2016;166:1-8. 
22. Venn D, Strazdins L. Your money or your time? How both types of scarcity matter to physical activity and healthy 
eating. Social Science & Medicine. 2017;172:98-106. 
23. Celnik D, Gillespie L, Lean MEJ. Time-scarcity, ready-meals, ill-health and the obesity epidemic. Trends in Food 
Science & Technology. 2012;27:4-11.
24. Wolfson JA, Bleich SN, Smith KC, Frattaroli S. What does cooking mean to you?: Perceptions of cooking and factors 
related to cooking behavior. Appetite. 2016;97:146-154.
25. Storfer-Isser A, Musher-Eizenman D. Measuring Parent Time Scarcity and Fatigue as Barriers to Meal Planning and 
Preparation: Quantitative Scale Development. Journal of Nutrition Education and Behavior. 2013;45:176-182. 
26. Jekanowski MD, Binkley JK, Eales J. Convenience, Accessibility, and the Demand for Fast Food. Journal of 
Agricultural and Resource Economics. 2001;26:58-74.
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27. Wolfson JA, Bostic S, Lahne J, et al. A comprehensive approach to understanding cooking behavior:Implications for 
research and practice. British Food Journal. 2017;119:1147-1158. 
28. McGowan L, Caraher M, Raats M, et al. Domestic cooking and food skills: A review. Critical Reviews in Food Science 
and Nutrition. 2017;57:2412-2431. 
29. Reicks M, Trofholz AC, Stang JS, Laska MN. Impact of Cooking and Home Food Preparation Interventions Among 
Adults: Outcomes and Implications for&#xa0;Future Programs. Journal of Nutrition Education and Behavior.46:259-
276.
30. Wansink B. Nutritional Gatekeepers and the 72% Solution. Journal of the American Dietetic Association. 
2006;106:1324-1327.
31. Hollywood L, Surgenor D, Reicks M, et al. Critical review of behaviour change techniques applied in intervention 
studies to improve cooking skills and food skills among adults. Critical Reviews in Food Science and Nutrition. 2017:1-
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32. Trubek AB, Carabello M, Morgan C, Lahne J. Empowered to cook: The crucial role of ‘food agency’ in making meals. 
Appetite. 2017;116:297-305.
33.  Pope L, Harvey-Berino J. Burn and Earn: A Randomized Controlled Trial Incentivizing Exercise During Fall Semester 
For College First-Year Students. Prev. Med. 2013;56:197-201. 
34. Jeffery RW. Financial incentives and weight control. Prev Med. 2013;55:S61-S67. 
35. Meyer Z. Growing home meal kit phenomenon is stirring up food indistry, stressing out supermarkets. USA 
Today2017. 
36. 48. Jeffery RW, Wing RR, Thorson C, et al. Strengthening behavioral interventions for weight loss: a randomized trial 
of food provision and monetary incentives. J. Consult. Clin. Psychol. 1993;61:1038. 
37. Diabetes Prevention Program Research Group. The Diabetes Prevention Program (DPP): description of lifestyle 
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type 2 diabetes. Diabetes care. 2007;30:1081-1087.
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success. Obesity. 2009;17:713-722.
40. Bandura A. Social foundations of thought and action: A social cognitive theory: Englewood Cliffs, NJ, US: Prentice-
Hall, Inc; 1986.
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43. Thompson FE, Dixit-Joshi S, Potischman N, et al. Comparison of Interviewer-Administered and Automated Self-
Administered 24-Hour Dietary Recalls in 3 Diverse Integrated Health Systems. American Journal of Epidemiology. 
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44. Guenther PM, Casavale KO, Reedy J, et al. Update of the Healthy Eating Index: HEI-2010. Journal of the Academy of 
Nutrition and Dietetics. 2013;113:569-580.
45. Lahne J, Wolfson JA, Trubek A. Development of the Cooking and Food Provisioning Action Scale (CAFPAS): A new 
measurement tool for individual cooking practice. Food Quality and Preference. 2017;62:96-105.
46. Wolfson JA, Smith KC, Frattaroli S, Bleich SN. Public perceptions of cooking and the implications for cooking 
behaviour in the USA. Public Health Nutrition. 2016;19:1606-1615.
47.  Bugos E, Frasso R, FitzGerald E, True G, Adachi-Mejia AM, Cannuscio C. Practical Guidance and Ethical 
Considerations for Studies Using Photo-Elicitation Interviews. Preventing Chronic Disease. 2014;11:E189.
Objectives:  Clearly state the primary and secondary objective(s) of the study.
Objective: The overall goal of the study is to determine if the addition of cooking classes to a standard behavioral weight loss 
program (COOKING) will improve weight loss and diet quality when compared to a weight loss program with an attention only 
control (DEMONSTRATION).
Aim 1: To determine if the addition of cooking classes to a behavioral weight control intervention improves weight loss and diet 
quality in overweight and obese adults.
Aim 2: To evaluate changes in food agency, cooking perceptions and cooking frequency for individuals participating in the 
COOKING versus DEMONSTRATION conditions.
Aim 3: To explore the feasibility and acceptability of adding cooking classes to a standard behavioral weight loss intervention.
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METHODS AND PROCEDURES 
Study Design: Describe the research design, including a description of any new methodology and its advantage over existing 
methodologies.  
We propose a two arm randomized control trial to 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 using online postings on local Front Porch 
Forum sites, the University of Vermont’s weekly announcement newsletter (research studies), and the University of Vermont 
Medical Center’s wellness calendar. Additionally, physical posters will be posted around UVM’s campus, UVMMC’s campus, 
and local physician’s offices who agree to display posters. We will also draw from a running waitlist of interested weight loss 
participants held by the Nutrition and Food Sciences Department. 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. 
 
To be eligible to participate, individuals must be at least 18 years old and overweight or obese (have a Body Mass Index (BMI) 
25-50 kg/m2). Individuals must also be free of medical problems that might contraindicate participation in a behavioral weight 
loss program containing an exercise component, not currently on medication that might affect weight loss, not pregnant or 
lactating, not enrolled in another weight reduction program and not currently cooking more than 3 meals at home per week. All 
participants must have a computer with Internet access (at home or work) in order to track their diet and exercise behaviors. 
Participants must also agree to be randomized to either of the study arms. 
Group assignments will be determined by a random assignment table created by the UVM Medical Biostatistics department 
using PROC PLAN in SAS. The program will stratify (arrange) groups so that they are statistically similar in distribution of both 
gender and weight classification (BMI<30 and BMI≥30  This program will allow study personnel to access a series of envelopes 
that will tell them which group the participant is assigned to. A participant ID number will be permanently associated with the 
participant to identify which group they have been assigned to. To avoid differential impact of and to assure equal 
representation in each group, eligible subjects will be stratified by BMI and gender.  To minimize loss to follow up, standardized 
training of staff will be provided focusing on rapport building, motivational interviewing and problem solving.  Participants will be 
educated on the importance of follow up and detailed contact information is obtained at study initiation.
The Behavioral Weight Loss Program: We 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,37-39 including restricted calorie intake and increased physical activity. 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. Target weight losses of 10% of baseline weight are promoted. Behavioral 
strategies are drawn from social cognitive theory40 and self-regulation theory41 and mirror the core components incorporated 
into such successful programs as Look AHEAD.42 In addition to attending weekly classes, participants will track their food 
intake, exercise, and weight. They will share their online tracking diaries with the group facilitator who will offer individualized 
feedback on their progress.  
The Cooking Program
Active Intervention. 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 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. 
Demonstrations. 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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Procedures:  Describe all procedures (sequentially) to which human participants will be subjected. Identify all procedures that 
are considered experimental and/or procedures performed exclusively for research purposes. Describe the types, frequency 
and duration of tests, study visits, interviews, questionnaires, etc.   Include required screening procedures performed before 
enrollment and while on study. Please provide in table, list or outline format for ease of review. (describe and attach all 
instruments)
Note: A clinical research protocol may involve interventions that are strictly experimental or it may involve some aspect of 
research (e.g., randomization among standard treatments for collection and analysis of routine clinical data for research 
purposes). It is important for this section to distinguish between interventions that are experimental and/or carried out for 
research purposes versus those procedures that are considered standard therapy. In addition, routine procedures performed 
solely for research purposes (e.g., additional diagnostic/follow-up tests) should be identified.
Recruitment and Screening
Advertisements will be posted to local Front Porch Forums, in a local newspaper, on the UVM employee newsletter, the 
University of Vermont Medical Center employee wellness newsletter (see attached for drafts of each advertisement). 
Individuals interested in participating will be directed to a secure online recruitment survey which queries for basic contact 
information and eligibly criteria (self-reported height and weight, age, cooking habits, etc.) and provides additional information 
regarding the study. Individuals who appear likely to be eligible based on this online registration will receive a brief phone 
screen conducted by research staff to confirm initial eligibility for the study and will be scheduled for an in-person orientation 
session where the study will be reviewed in detail, questions will be addressed. Participants will be provided with an orientation 
packet that includes directions for using MyFitnessPal, a handout outlining MyFitnessPal privacy information, directions for 
photo elicitations, and an informed consent document will be provided to take home.  Participants interested in enrolling in the 
study will be asked to sign a consent form approved by the UVM Research Protections Office and baseline data collection will 
begin, including collection of height and body weight data. Participants will be asked to record dietary intake for three days 
using My Fitness Pal as a behavioral run in and to complete questionnaires online. Directions for how to access both of these 
elements will be provided to participants and a helpline contact will be provided. Only after all these eligibility criteria have been 
satisfied will participants be randomized.
The College of Medicine Bioinformatics will create a randomization scheme that allows the research coordinator to blindly 
assign participants to one of the two study groups.  
Questionnaires will be administered through the study website at baseline and study end. Participants will receive links to the 
questionnaires and reminders to complete questionnaires via email. These measures are outlined in greater detail below. In 
addition to baseline and study end questionnaires, weekly data collection will be administered through the study website. 
Participants will receive reminders to complete weekly data submissions, and will be given information regarding a helpline for 
using the study website and data entry. 
Table 1 outlines when each measure will occur during the study. 
Measures
Baseline
Weekly
Week 12
Week 24
ASA24
HEI (calculated)
CAFPAS
Cooking Perceptions and Behaviors 
Height, Weight, BMI
Cooking Frequency
Photo Elicitation
Class Evaluation
Quantitative Measures
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) – The ASA24 is a web-based dietary
assessment tool developed by the National Cancer Institute that allows collection of multiple, automatically coded, self-
administered 24-hour recalls. The ASA24 has been validated and used in many different populations and nutrition studies.43 
When completing the ASA24, the participant is first prompted to report the time of all food and drinks consumed. Next, they 
search a list of foods and select which foods they ate at each meal. If there is a gap of more than three hours between reported 
eating occasions participants are then asked if they ate anything during that gap. There is then a detail pass where participants 
are asked about preparation methods, portion sizes and anything they added to a food. Finally, participants are asked about 
foods that people commonly forget to include and can add any of these foods to their recall. Detailed instructions with pictures 
for completing the recall are available on the ASA24 website and participants will be made aware of this resource. 
Foods included in the ASA24 all code to the USDA’s Food and Nutrient Database for Dietary Studies, and so all entries can be 
automatically coded.43 Healthy Eating Index (HEI) – The HEI is a measure of overall diet quality, and can assess compliance 
with the U.S. Dietary Guidelines, as well as measure changes in dietary patterns. The HEI is updated with each set of Dietary 
Guidelines, and has been validated for the 2005 and 2010 Dietary Guidelines.44 The HEI is a valid and reliable tool for 
assessing dietary quality in a variety of population subgroups and nutrition interventions.44 The validation for the 2015 Dietary 
Guidelines is expected soon. The HEI takes into account one’s intake of the following foods when calculating a total score, total 
fruit, whole fruit, total vegetables, dark green vegetables, legumes, whole grains, dairy, total protein foods, seafood, eggs, soy 
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products, nuts and seeds, refined grains, saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, 
sodium, calories from added sugars, and total calories.44 The HEI calculates final scores from 24-hour recalls like the ASA24.
Cooking and Food Provisioning Action Scale (CAFPAS): The CAFPAS scale measures cooking and food preparation practices 
or the degree to which individuals can set and achieve cooking and food provisioning goals. The CAFPAS includes 28 items 
with three subscales: Food Self-Efficacy, Food Attitude, and Structure. The CAFPAS scale has been shown to predict reported 
meals cooked per week and has adequate internal validity and test-retest reliability.45 
The Cooking Perceptions and Behaviors Questionnaire: The Cooking Perceptions and Behaviors questionnaire is a 53-item 
survey designed to assess three factors: Perceptions of Cooking, Cooking Confidence and Attitudes, and Cooking Behaviors. 
This survey has been used in previous research to measure cooking perceptions and behavior.46
Weekly Assessment of Cooking Frequency:  Each week, participants will use the study website to record how many times that 
week they cooked at home. The weekly surveys should take 5 minutes to fill out.
Height, Weight, and BMI: Measurements will be taken at the time of weekly classes. Height will be measured with a 
standardized stadiometer. Weight will be measured on a calibrated research scale (Tanita), and BMI will be calculated using 
height (m) and weight (kg)  measurements. 
Demographics Questionnaire: A five question paper questionnaire will be given to each participant at the first class meeting. 
Participants will be asked to fill out the questionnaire in private during the time they are having their weight and height 
measured. This questionnaire will gather information regarding participants marital status, education, and employment. 
Participants may leave any questions they do not wish to answer unanswered. Data from these questionnaires will be recorded 
in to the REDCap study website by study staff. Once data has been recorded, paper questionnaires will be destroyed. 
Qualitative Measures
Photo Elicitation – With photo elicitation, participants take photos of a particular topic, and then these photos are used as the 
starting point for an interview between the participant and researcher. Photo elicitation has been used in public health research 
previously with a variety of projects and populations.47 For this study, participants will be asked to take photos with their 
smartphones or cameras and then upload two photos each week to the study website. Instructions will ask participants to 
capture the meal that week they feel most represents their interpretation of a “healthy meal,” and the meal they ate that week 
that least represents their interpretation of a “healthy meal.” Both the intervention and control group will be instructed to take 
these weekly photos and label them as a meal they cooked at home or a meal they did not cook at home. Participants will be 
informed verbally and in writing that they should not include themselves or others in the pictures they submit, and that in order 
to protect their privacy, any pictures that contain individuals will be deleted and they will be asked to submit a replacement 
picture. At orientation, participants will be provided with an instruction sheet which outlines how they are expected to submit 
their meal photos and reiterates that they should not include themselves or others in the photos. At the conclusion of the study, 
investigators will randomly select ten participants from the control group and ten participants from the intervention group to 
interview about their photos. The interviews will ask questions about why the photos represented healthy or unhealthy meals to 
the participants, where the meals were prepared, how the photos may have changed over time, and how the various 
interventions may have impacted the photos.
Cooking Class/Demonstration Evaluation – At the conclusion of the cooking classes for the intervention group and the cooking 
demonstrations for the control group there will be a class evaluation given to assess participants’ impressions of the classes or 
demonstrations. This evaluation will be available on the study website, and participants will have time in class to complete the 
evaluation and can do so on their smart phone or tablet. Participants will also have the option to complete this evaluation at a 
later time on their home computer. 
Intervention
Participants in both treatment and control groups will attend weekly sessions of the behavioral weight loss program. Sessions 
will be 1 hour long and will include a weekly lesson as well as a group discussion. These sessions will be standalone meetings 
(1 hour) every other week for 24 weeks and paired with the cooking class biweekly (2 hours). Weight loss meetings and 
cooking classes will occur in the same space. 
Every week participants will be asked to track their food, exercise, and weight every day. The tracking will be done through My 
Fitness Pal and reviewed by the group facilitator on a weekly basis in order to offer individualized feedback to participants. 
Participants will be asked to complete short weekly homework assignments that relate to the week’s lesson. Homework will 
also be reviewed by the group facilitator. 
Facilities and Equipment Needed
Cooking Labs – The cooking classes and demonstrations will take place in the Nutrition and Food Sciences teaching kitchen 
located in the Marsh Life Science building. The teaching kitchen has room for 16 students to complete hands on cooking labs, 
and an additional space where students can get directions, eat, and watch cooking demos. The kitchens are fully stocked with 
the necessary kitchen equipment.
Follow-up Data Collection 
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Participants will be alerted prior to their follow-up assessment appointment to complete the online questionnaires which are 
anticipated to take approximately 30 minutes to complete and 3 days of the ASA24 (less than 30 minutes per day).  They will 
also be scheduled to come into the research office to get weighed, at which time the weight loss achieved will be recorded.
All participants (in both treatment conditions) will be offered small incentives such as tote bags, cookbooks, exercise 
equipment, gift cards, etc. (valued at approximately $ 5-25) after completion of the follow-up data collection visits as a token of 
appreciate for their participation.  
For research involving survey, questionnaires, etc.:  Describe the setting and the mode of administering the instrument and 
the provisions for maintaining privacy and confidentiality.  Include the duration, intervals of administration, and overall length of 
participation. (describe and attach all instruments)
Not applicable
Surveys and questionnaires will be administered online through the study website (REDCap).  Participants will be sent links to 
questionnaires through their email. Participants will be able to save and return to questionnaires with a unique 8 digit ID 
provided by REDCap, however participants will not have access to review the questionnaires after completion or to make 
changes after submitting the forms.  They will be provided with a helpline contact should they encounter difficulty in completing 
the forms.  If participants prefer, they can complete the forms using a paper copy rather than online. It is expected that the 
online baseline and follow-up assessment questionnaires will take less than 30 minutes to complete and the in-person follow up 
assessment (weighing in) will take less than 30 minutes. The baseline and follow-up ASA24 3 day tracking is estimated to take 
less than 30 minutes for each entry. 
Statistical Considerations: Delineate the precise outcomes to be measured and analyzed. Describe how these results will be 
measured and statistically analyzed. Delineate methods used to estimate the required number of subjects. Describe power 
calculations if the study involves comparisons.  Perform this analysis on each of the primary and secondary objectives, if 
possible. 
Aim 1: To determine if the addition of cooking classes to a behavioral weight control intervention improves weight loss and diet 
quality in overweight and obese adults.
Hypothesis 1: Weight loss and diet quality (as measured by the Healthy Eating Index) will be significantly greater in the 
Cooking vs. Demonstration condition at 12 and 24 weeks.
Aim 2: To evaluate changes in food agency, cooking perceptions and cooking frequency for individuals participating in the 
COOKING versus DEMONSTRATION conditions.
Hypothesis 2: Food agency, cooking perceptions and cooking frequency will be significantly greater in the
COOKING versus DEMONSTRATION conditions at 12 and 24 weeks.
Analysis Aims 1 and 2: The first and second hypotheses will be addressed using a repeated measures analysis of variance 
with treatment condition as the between group factors and assessment time as the within subject factor recalling that the 
baseline value will be subtracted from all subsequent values. An intent-to-treat approach will be used as the definitive analysis 
perspective for both the primary hypothesis testing and the secondary analysis of data. The use of a multiple imputation 
process will be conducted if the missing data can be assumed to be missing at random or completely at random. The intent-to-
treat approach will require the use of a mixed model approach that can deal with repeated measures data and which can also 
deal with missing data (e.g. SAS ProcMixed or BMDP5V)
Aim 3: To explore the feasibility and acceptability of adding cooking classes to a standard behavioral weight loss intervention.
Analysis Aim 3: Feasibility and acceptability will be monitored by evaluating attendance and self-monitoring as well as 
qualitative data related to the perceived usefulness of the cooking classes or demonstrations.
Risks/Benefits:  Describe any potential or known risks.  This includes physical, psychological, social, legal or other risks.  
Estimate the probability that given risk may occur, its severity and potential reversibility.  If the study involves a placebo or 
washout period, the risks related to these must be addressed in both the protocol and consent.  Describe the planned 
procedures for protecting against or minimizing potential risks and assess their likely effectiveness.  Where appropriate, discuss 
plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects.   Discuss the 
potential benefits of the research to the subjects and others.  Discuss why the risks to the subjects are reasonable in relation to 
the anticipated benefits to subjects and others.  Discuss the importance of the knowledge gained or to be gained as a result of 
the proposed research and why the risks are reasonable in relation to the knowledge that reasonably may result.  If there are 
no benefits state so.
Potential Risks.  
No social, legal or other risks are anticipated as part of this project. All assessment procedures and intervention 
recommendations have been used in previous studies without adverse outcomes.  Assessment methods reflect procedures 
that individuals might encounter in a routine health care visit (i.e., weight assessment) or questionnaire measures that have 
been implemented in numerous studies without difficulties (e.g., dietary intake and physical activity questionnaires). 
Intervention methods are similarly very low risk.  Behavioral weight control interventions recommend that individuals make 
changes to dietary intake and physical activity, all of which are comparable to the recommendations made by national advisory 
panels and recognized leaders in health recommendations.  Specifically, the intervention goals outlined are consistent with 
NHLBI recommendations, the American Heart Association, the American Diabetes Association, etc.  These intervention 
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recommendations for diet and activity habit change have minimal risk.  The most common risk associated with participation in 
the interventions is soreness or musculoskeletal injury, although this occurs infrequently.  Precautions will be taken to further 
minimize risk by making recommendations for graded increases that slowly increase activity duration and frequency and 
appropriate stretching.  Moderate exercise prescriptions rather than vigorous levels of physical activity should also minimize 
these risks. 
A potential risk in the present study is that participants may fail to lose weight in the program, but this risk occurs in all 
approaches to weight control. Alternative approaches to weight loss, including stricter diets, pharmacological interventions, and 
surgical procedures, are considered to have greater risk than the dietary and physical activity program described in this 
protocol. Participants may utilize unhealthy dietary practices to lose weight and/or may experience minor musculoskeletal 
injuries during exercise; however, this is considered unlikely and precautions will be taken to further minimize this risk. 
Protection Against Risk.  Every effort will be made to keep participants’ information private and confidential. Confidentiality will 
be ensured by coding data with a unique ID number, and all data collected will be stored in locked files with access restricted to 
study personnel, and password protected computer data files.  Participants will not be personally identified in any scientific 
reports generated by the study or any other dissemination efforts. All results will be presented in aggregate form. All project 
staff will undergo training and ongoing continuing education about methods to protect confidentiality. 
Participants will be taught warm-up and stretching techniques to precede all exercise sessions to minimize the chance of 
muscle injury. In addition, weekly self-monitoring diaries will be submitted and reviewed at regular intervals throughout the 
study allowing for assessment of nutritional adequacy. No calorie goals will be set below 1200 kcal/day to provide participants 
with sufficient calories for a nutritionally adequate diet. Participants who become pregnant during the course of the 18-month 
study will be dropped from the treatment protocol, and participants who experience other medical problems during the course of 
the study will be referred to their personal physician for care as appropriate.
Potential Benefits 
The potential benefit to the participants will be the skills and knowledge in lifestyle behaviors to successfully lose weight and 
prevent/deter weight re-gain.  Further, participants may benefit from the improved health and psychological well-being that 
commonly accompanies weight loss.  These benefits to the individual participant are considered substantial.
This study will expand our understanding of cooking’s potential as a health behavior, by testing several novel interventions, 
including a cooking pedagogy designed to increase food agency, and provision of material support for cooking at home.  Very 
little previous research has addressed cooking at home as a potential health behavior.  Even less previous work has attempted 
to motivate people to cook at home.  Furthermore, the pedagogy to be used for the cooking class intervention in this study has 
been explicitly designed to increase one’s food agency, a new theoretical concept, that aims to empower one’s cooking 
practice.  The relationship between food agency and health has not been explored thoroughly, and this study will examine 
associations between food agency, cooking at home, diet quality, and weight outcomes.  In addition to using a new 
methodological scale associated with food agency, the proposal will use the qualitative technique of photo elicitation to gather 
qualitative evidence of participants’ cooking experiences, perceptions, and barriers. Therefore, the results of this study will be of 
interest to those designing behavioral weight loss programs for adults. 
Therapeutic Alternatives:  List the therapeutic alternatives that are reasonably available that may be of benefit to the potential 
subject and include in the consent form as well.
Not Applicable
There are a variety of weight loss programs available as a therapeutic alternative.  Individuals can join commercial programs or 
speak with their physician to get assistance with their weight loss efforts. In addition, pharmacological interventions, and 
surgical procedures that produce weight loss are available, if deemed appropriate by the individual’s physician.
Data Safety and Monitoring:  The specific design of a Data and Safety Monitoring Plan (DSMP) for a protocol may vary 
extensively depending on the potential risks, size, and complexity of the research study.  For a minimal risk study, a DSMP 
could be as simple as a description of the Principal Investigator’s plan for monitoring the data and performance of safety 
reviews or it could be as complex as the initiation of an external, independent Data Safety and Monitoring Board (DSMB). The 
UVM/UVM Medical Center process for review of adverse events should be included in the DSMP.  
Safety of the subjects. The proposed study poses no serious physical, psychological, or legal risks to participants. Therefore, 
the trial will be monitored by the PI’s (Jean Harvey, PhD, RD and Lizzy Pope, PhD, RD), the Research Project Coordinator 
(Mattie Alpaugh, MSD)  and group facilitators. Weekly meetings or conference calls will be held to evaluate the status of study 
participants. Any serious adverse events will be recorded on a standard form and reported to the Research Coordinator, to the 
PI’s and the UVM IRB. 
Data. Research participants will complete some questionnaires online as dictated by the study protocol. Only their subject 
identification number will appear on the questionnaires; no names or other personal identifiers will be included on data 
collection forms. All data collected by the research coordinator is considered part of the participant’s confidential record. Data 
collected from research participants will be stored as password protected electronic data files.  All data will remain confidential. 
A file will be maintained that associates the participant name with that participant’s study identification. This file will remain in a 
locked file cabinet at UVM and will not be stored with the actual study data.  This file will be destroyed at the end of the study.
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Storage of Collected Data. All electronic data will be stored in password-protected files. Data will only be accessed when 
coded or audited. The study’s project manager will work closely with the UVM Medical Biostatics facility to ensure the secure 
storage of all project data, using appropriate data safety procedures. Site specific data, or data not initially entered into 
REDCap will be sent to the study statistician using secure FTP transfers.  All original transferred data files will be stored on a 
dedicated PC with limited and secured password protected access in a private locked office.  Data management and editing of 
these files will take place prior to archiving any data files into a SAS based project specific database with specific 
documentation of any editing and data review adjudications while the original data files will be retained intact. Only archived 
data files will be used to derive analysis data files to address specific hypotheses or project monitoring reports
The data entry system will require a login identification and password in order to gain access to the data. Where appropriate, 
validation and range rules will be applied to the actual entry field. Only the Biostatistics staff will be able to view the data in its 
raw state. All other authorized personnel (Principal Investigators, Research Coordinator) will view data via forms and reports 
created by the Biostatistics staff.
Data collected using paper questionnaires will be entered by study staff into the REDCap system. Prior to being entered into 
REDCap all hardcopies of questionnaires will be stored in a locked filing cabinet in a locked office. Once data has been 
entered, hardcopies will be destroyed using a locked Secure Shred bin located in the Nutrition and Food Sciences Department. 
Direct Data Entry by Participants.  Questionnaires will be completed by participants directly online.  These questionnaires will 
utilize formats that include range and validity checks, as appropriate, as well as queries to assure that all items have been 
answered before completing the form, to assure the most accurate data collection and will be identified only by unique 
participant IDs.  Participants will not have access to review the questionnaires after completed or to make changes after 
submitting the forms.  Participants will be provided with a “helpline” contact should they encounter difficulty in completing the 
forms.  
Access to Cleaned Computer Data. Once the study is complete, and all data have been collected, entered, and passed the 
verification process, the director of the Bioinformatics facility, will make the data available to the Principal Investigators and their 
designates. Only the Principal Investigators can give permission for the release of aggregated study data. No confidential 
information may be released without the express written consent of the study participants. Only copies of the aggregated, de-
identified finalized data will be released.
Adverse Event and Unanticipated Problem (UAP) Reporting:  Describe how events and UAPs will be evaluated and 
reported to the IRB.  All protocols should specify that, in the absence of more stringent reporting requirements, the guidelines 
established in the Committees on Human Research “Adverse Event and Unanticipated Problems Reporting Policy” will be 
followed.  The UVM/UVM Medical Center process for review of adverse events and UAPs to subjects or others should be 
included in the DSMP.  
Weekly meetings or conference calls will be held to evaluate the status of study participants. Any serious adverse events will be 
recorded on a standard form and reported to the Research Coordinator, to the PI’s and the UVM IRB.
Withdrawal Procedures:  Define the precise criteria for withdrawing subjects from the study.   Include a description of study 
requirements for when a subject withdraws him or herself from the study (if applicable).
Participants may withdraw from the study at any time by notifying the PI or Study Coordinator in writing (or by email) of their 
intention.  
If necessary, subjects may be terminated or withdrawn by the Principal Investigator without the consent of the participant if 
continued participation would be contraindicated, including because the participant (1) becomes pregnant (and therefore it 
would not be appropriate to follow a weight loss program); (2) develops a life threatening disease for which weight loss is 
contraindicated; (3) joins another weight control program (such as Weight Watchers, Jenny Craig, NutriSystems, etc.); or (4) 
the participant moves more than 120 miles from the clinical center with no plans to return during study assessment windows.
Sources of Materials:  Identify sources of research material obtained from individually identifiable human subjects in the form 
of specimens, records or data.  Indicate whether the material or data will be obtained specifically for research purposes or 
whether use will be made of existing specimens, records or data.
The anthropometric, behavioral, and self-report questionnaire data collected in this study will be obtained for research purposes 
only.
DRUG AND DEVICE INFORMATION 
Investigators are encouraged to consult the UVM Medical Center Investigational Pharmacy Drug Service (847-4863) prior to 
finalizing study drug/substance procedures.
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Drug (s)
X
Not applicable
Drug name – generic followed by brand name and common abbreviations. Availability – Source and pharmacology; vial or 
product sizes and supplier.  If a placebo will be used, identify its contents and source. (attach investigational drug brochure)
Preparation:  Reconstitution instructions; preparation of a sterile product, compounded dosage form; mixing guidelines, 
including fluid and volume required.  Identify who will prepare.
Storage and stability – for both intact and mixed products.  
Administration – Describe acceptable routes and methods of administration and any associated risks of administration.
Toxicity – Accurate but concise listings of major toxicities.  Rare toxicities, which may be severe, should be included by 
indicated incidence.  Also adverse interactions with other drugs used in the protocol regimen as well as specific foods should 
be noted.  Address significant drug or drug/food interactions in the consent form as well.  List all with above details.
Is it FDA approved: (include FDA IND Number)
1.  in the dosage form specified?  If no, provide justification for proposed use and source of the study drug in that form.
2.  for the route of administration specified?  If no, provide justification for route and describe the method to accomplish.
3.  for the intended action?
Device (s)
X
Not applicable
Device name and indications (attach investigational device brochure)
Is it FDA approved: (include FDA IDE Number)
1.  for indication specified? If no, provide justification for proposed use and source of the device.
Risk assessment (non-significant/significant risk) - PI or sponsor needs to assess risk of a device based upon the use of the 
device with human subjects in a research environment.  
SUBJECT CHARACTERISTICS, IDENTIFICATION AND RECRUITMENT 
Subject Selection:  Provide rationale for subject selection in terms of the scientific objectives and proposed study design.
This study aims to evaluate changes in food agency including cooking frequency between the two interventions. Therefore, 
subjects are selected to provide a sample of individuals positioned to increase their food agency and cooking frequency.  
Towards this end, only individuals who are cooking (from scratch) no more than 3 meals at home per week will be eligible. All 
participants must have a computer or smart device with internet access (at home or work) in order to track their diet and 
exercise behaviors, as this is central to the behavioral weight loss intervention.  The study does not seek to introduce use of 
this technology to naïve users who have no daily access.  Furthermore, 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 so that only adequately motivated individuals who are likely to stay engaged for the full 24 week 
study period are enrolled and randomized.
Vulnerable Populations:  Explain the rationale for involvement of special classes of subjects, if any.  Discuss what procedures 
or practices will be used in the protocol to minimize their susceptibility to undue influences and unnecessary risk (physical, 
psychological, etc.). 
X
Not applicable
Number of Subjects:  What is the anticipated number of subjects to be enrolled at UVM/UVM Medical Center and in the case 
of a multi-center study, with UVM/UVM Medical Center as the lead, the total number of subjects for the entire study.
This is a pilot study with no previous data available to calculate expected statistical power. The sample size chosen was 
practical as our foods lab can only accommodate 16 people at a time.  Two waves of each intervention arm would give us data 
on approximately 64 subjects.  This preliminary data will be used to determine the sample size power needed for a larger study 
with sufficient statistical power.
Inclusion/Exclusion Criteria:  Eligibility and ineligibility criteria should be specific. Describe how eligibility will be determined 
and by whom.  Changes to the eligibility criteria at a later phase of the research have the potential to invalidate the research.
To be eligible to participate, participants must be at least 18 years old and have a Body Mass Index (BMI) between 25-50 
kg/m2. Review of previous research studies conducted by this research groups has found that individuals with a BMI greater 
than 50 do not have success with the planned intervention. These individuals require a more intensive approach to see a 
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reduction in weight than what they study intervention offers. Individuals must also be free of medical problems that might 
contraindicate participation in a behavioral weight loss program containing an exercise component, not currently on medication 
that might affect weight loss, and not enrolled in another weight reduction program (all of which would be problematic 
confounds for the primary outcome of body weight).  Participants will also be excluded if they are pregnant, plan to become 
pregnant in the next six month, or are lactating as these would be problematic confounds for the primary outcome of body 
weight. Additionally, weight loss is not generally recommended for pregnant women and when it is must be closely monitored 
by a physician. Participants will not be eligible if they are currently cooking (from scratch) more than 3 meals at home per week. 
All participants must have a computer with Internet access (at home or work) in order to track their diet and exercise behaviors. 
Participants must also agree to be randomized to either of the study arms and be available for both scheduled meeting times.
Inclusion of Minorities and Women:  Describe efforts to include minorities and women.  If either minorities or women are 
excluded, include a justification for the exclusion. 
Women and minorities will be included. Women are more likely to participate in weight loss interventions than men. 
Inclusion of Children: Describe efforts to include children.  Inclusion is required unless a clear and compelling rationale shows 
that inclusion is inappropriate with respect to the health of the subjects or that inclusion is inappropriate for the purpose of the 
study.  If children are included, the description of the plan should include a rationale for selecting or excluding a specific age 
range of children.  When included, the plan must also describe the expertise of the investigative team in working with children, 
the appropriateness of the available facilities to accommodate children, and the inclusion of a sufficient number of children to 
contribute to a meaningful analysis relative to the purpose of the study.  If children are excluded then provide appropriate 
justification. Provide target accrual for this population.
We propose to exclude children under 18 years of age because the proposed behavioral weight loss intervention has not been 
studied in children. Effective behavioral obesity treatment for children requires appropriate adaptation for their developmental 
needs. Thus, the current intervention approach may not be appropriate for younger children. However, children aged 18-21 will 
be eligible to participate. 
For protocols including the use of an investigational drug, indicate whether women of childbearing potential have been included 
and, if not, include appropriate justification.
Not applicable 
If HIV testing is included specifically for research purposes explain how the test results will be protected against unauthorized 
disclosure.  Include if the subjects are to be informed of the test results.  If yes, include the process and provision for 
counseling.  If no, a rationale for not informing the subjects should be included.  
X
Not applicable
Recruitment:  Describe plans for identifying and recruitment of subjects.  All recruitment materials (flyers, ads, letters, etc) 
need to be IRB approved prior to use.  
Subjects will be recruited to participate from the greater Burlington area using social media, newspaper ads or by drawing on 
our existing waiting list.
Interested persons will be directed to a secure online recruitment survey which queries for basic contact information and eligibly 
criteria (self-reported height and weight, age, etc.) and provides additional information regarding the study. Individuals who 
appear likely to be eligible based on this online registration will receive a brief phone screen conducted by research staff to 
confirm initial eligibility for the study and will be scheduled for an in-person orientation session where the study will be reviewed 
in detail, questions will be addressed and an informed consent document will be provided to take home.  After considering the 
study for a minimum of 1 week, interested participants will be asked to sign a consent form at the first baseline data collection 
visit.  Consent forms will have been approved by the University of Vermont Institutional Review Board. 
FINANCIAL CONSIDERATIONS 
Expense to Subject:  If the investigation involves the possibility of added expense to the subject (longer hospitalization, extra 
studies, etc.) indicate in detail how this will be handled. In cases where the FDA has authorized the drug or device company to 
charge the patient for the experimental drug or device, a copy of the authorization letter from the FDA or sponsor must 
accompany the application. Final approval will not be granted until the IRB receives this documentation.
There are very limited circumstances under which study participants may be responsible (either directly or via their insurance) 
for covering some study-related expenses. If the study participant or their insurer(s) will be billed for any portion of the research 
study, provide a justification as to why this is appropriate and acceptable. For example, if the study involves treatment that is 
documented standard of care and not investigational, state so. In these cases, the protocol and the consent should clearly 
define what is standard of care and what is research.
No additional expense to participants is anticipated, other than parking costs for onsite visits of $1/hour if arriving before 3:30, or 
childcare costs, if needed, and no proposed research procedures will be billed to participants.
Payment for participation:  Describe all plans to pay subjects, either in cash, a gift or gift certificate. Please note that all 
payments must be prorated throughout the life of the study. The IRB will not approve a study where there is only a lump sum 
payment at the end of the study because this can be considered coercive. The amount of payment must be justified. Clarify if 
subjects will be reimbursed for travel or other expenses.
Not applicable
CHRBSS (Behavioral) #19-0131 Approved: 6/16/2019

HS Protocol Form 7/14/17
Participants will be offered small tokens for attending data collection visits.  Items such as tote bags, cookbooks, exercise 
equipment, gift cards, etc. (value of $ 5-25) will be provided to those who provide follow-up data. 
Collaborating Sites.  When research involving human subjects will take place at collaborating sites or other performance sites 
when UVM/UVM Medical Center is the lead site, the principal investigator must provide in this section a list of the collaborating 
sites and their Federalwide Assurance numbers when applicable.  (agreements may be necessary)
X
Not applicable
INFORMED CONSENT 
Consent Procedures:  Describe the consent procedures to be followed, including the circumstances under which consent will 
be obtained, who will seek it, and the methods of documenting consent.  Specify the form(s) that will be used e.g. consent (if 
multiple forms explain and place identifier on each form), assent form and/or HIPAA authorization (if PHI is included).  These 
form(s) must accompany the protocol as an appendix or attachment.  
Note:  Only those individuals authorized to solicit consent may sign the consent form confirming that the prospective subject was 
provided the necessary information and that any questions asked were answered.
Interested persons will be directed to a secure online recruitment survey which queries for basic contact information and eligibly 
criteria (self-reported height and weight, age, etc.) and provides additional information regarding the study. Individuals who 
appear likely to be eligible based on this online registration will receive a brief phone screen conducted by research staff to 
confirm initial eligibility for the study and will be scheduled for an in-person orientation session.  During the orientation 
designated staff who have been certified to obtain consent will discuss the informed consent form with the subject volunteer, 
reviewing each aspect of the consent form and allowing individuals to ask questions.  This orientation may be delivered in a 
group setting, although if scheduling does not permit engaging in the group orientation, the subject volunteer may be orientated 
individually.  Subject volunteers often benefit from the group process in that they hear questions that others ask which may not 
have occurred to them but are of interest to them in their decision making about participation.  Subject volunteers will be 
provided with a copy of the consent form at the group orientation but will not be asked to sign the form until they return for an 
individual visit.  Individuals who remain interested in the study after the orientation session and have reviewed the consent form 
will be invited to return for an individual screening session at which the remainder of the consent process will occur.  This 
consent process will take place in a quiet and private room.  The person obtaining consent at this visit will be an individual who 
has been certified to obtain consent for the study and this person will thoroughly explain each element of the document and 
outline the risks and benefits, alternate treatment(s), and follow-up requirements of the study.  Participant privacy will be 
maintained and questions regarding participation will be answered.  No coercion or undue influence will be used in the consent 
process.  No research related procedures will be performed prior to obtaining informed consent.  All signatures and dates will be 
obtained.  A copy of the signed consent will be given to the participant.  The informed consent process will be documented in 
each subject’s research record.
Following informed consent, the remainder of screening will be conducted (e.g., self monitoring diary completed, discussion of 
randomization acceptance) and baseline data will be collected.  Only those individuals with complete baseline data will be 
randomized.
The contact information and screening information of participants who decline consent will be destroyed. 
Information Withheld From Subjects:  Will any information about the research purpose and design be withheld from potential 
or participating subjects?  If so, explain and justify the non-disclosure and describe plans for post-study debriefing.  
X
Not applicable
Attach full grant application, including budget information and/or any contract or draft 
contract associated with this application. 
All materials must be submitted electronically to the IRB via InfoEd. Proper security access is 
needed to make electronic submissions. Visit the InfoEd Resource Materials page for more 
information.
CHRBSS (Behavioral) #19-0131 Approved: 6/16/2019