ObesityiChefNCT03783962
Examining Cooking as a Health Behavior
A study testing Active Intervention - Cooking and Demonstrations - Cooking in people with Obesity, run by University of Vermont at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Active Intervention - Cooking and Demonstrations - Cooking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Active Intervention - Cooking, Demonstrations - Cooking
- Keywords
- behavioral weight loss intervention, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Intervention - CookingBehavioural
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.
Demonstrations - CookingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention - Cooking | Experimental | 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. Receives: Behavioral: Active Intervention - Cooking |
| Demonstrations - Cooking | Active comparator | 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. Receives: Behavioral: Demonstrations - Cooking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Weight loss from baseline at 24 weeks
Measured: 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
Measured: Baseline and 24 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Treatment Engagement- Attendance
Percent (of 24 possible) classes attended will be calculated to determine treatment engagement
Measured: 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
Measured: Baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start1 Nov 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean R. Harvey, PhD, RD, University of Vermont
- Investigators
- Jean R Harvey, PhD, RD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783962
- Sponsor's protocol ID
- CHRBSS 19-0131
- Acronym
- iChef
- Status last verified
- May 2021
- First submitted
- 5 Dec 2018
- Last updated
- 17 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Cooking as a Health Behavior
- ClinicalTrials.gov ID
- NCT03783962
- Acronym / sponsor ID
- iChef / CHRBSS 19-0131
- Conditions
- Obesity
- Keywords
- behavioral weight loss intervention, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Posted 17 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Intervention - Cooking | Experimental | Behavioral: Active Intervention - CookingTwelve 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. |
| Demonstrations - Cooking | Active comparator | Behavioral: Demonstrations - CookingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Intervention - CookingKey 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. | Behavioural | Active Intervention - Cooking |
| Demonstrations - CookingThe 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. | Behavioural | Demonstrations - Cooking |
Primary outcome
Weight Change
Time frame: 24 weeks
Weight loss from baseline at 24 weeks
Change From Baseline in the Total HEI Score, as a Measure of Diet Quality Change
Time frame: Baseline and 24 weeks
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: 1. Adequacy components are encouraged. Higher scores reflect higher intakes. 2. 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
9 secondary outcomes
Cooking and Food Practices Change - Total Score
Time frame: 24 weeks
Cooking and Food Practices Change - Structure Subscale
Time frame: 24 weeks
Cooking and Food Practices Change - Attitude Subscale
Time frame: 24 weeks
Cooking and Food Practices Change - Self Efficacy Subscale
Time frame: 24 weeks
Cooking Frequency Change - Breakfast
Time frame: 24 weeks
Cooking Frequency Change - Lunch
Time frame: 24 weeks
Cooking Frequency Change - Dinner
Time frame: 24 weeks
Treatment Engagement- Attendance
Time frame: 24 weeks
Treatment Engagement- Food Journaling Compliance
Time frame: Baseline to six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean R Harvey, PhD, RD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Intervention - Cooking and Demonstrations - Cooking in people with Obesity, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.