ObesityNCT02202733
Skill-based Cooking Intervention to Reduce Eating Out
A study testing Cooking in people with Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The primary goal of the study is to use an iterative process to develop and refine a skill-based cooking intervention to decrease the consumption of energy from foods prepared away from home for evening meals, decrease energy intake, and promote a healthy weight in parents and children aged 3-10 years. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Cooking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- be ≥18 years of age
- have a child between the ages of 3 and 10 years-old
- report being the primary caretaker and have the primary feeding responsibility of the child for dinner/supper
- able to read, speak, and understand English
- have transportation to the Medical Center
- report their family including the child eats pre-prepared frozen food, restaurant food, fast food, or take-out for dinner ≥3 times per week
Show all 18Show fewer
- has a working telephone number
- is able to attend the scheduled date and time of a focus group.
- caretaker is ≥18 years of age
- caretaker is overweight or obese (BMI≥25)
- has a child between the ages of 3 and 10 years-old
- report being the primary caretaker and have the primary feeding responsibility of the child for dinner/supper
- caretaker is able to read, speak, and understand English
- has transportation to the medical center and the instructional kitchen
- does not plan to move out of the area before June 2015
- reports their family including the child eats convenience food, restaurant food, fast food, or take-out for dinner ≥3 times per week
- reports access to a kitchen
- able to attend the scheduled date and time of the sessions.
Who cannot join
- the caretaker or child is currently participating in a weight loss program and/or taking weight loss medication
- have a medical condition known to promote growth (e.g., Prader-Willi syndrome, Cushing's syndrome) or had gastric bypass surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Caretaker Cooking Skills Intervention to Reduce Eating Out
The primary goal of the study is to use an iterative process to develop and refine a skill-based cooking intervention to decrease the consumption of energy from foods prepared away from home for evening meals, decrease energy intake, and promote a healthy weight in parents and children aged 3-10 years.
Read the detailed description
Phase I. Conduct 2-4 focus groups with 6-10 caretaker, who report eating foods prepared away from home ≥3 times per week, per group to gain insight into current eating behaviors of foods prepared away from home, current perceptions about a home prepared evening meal, and barriers to preparing evening meals at home. Information gathered during Phase I will be used to inform intervention development in Phase II.
Phase II. Develop, refine, and manualize a skill-based cooking intervention for overweight/obese caretakers of a child aged 3-10 years. The aim of Phase II is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and promote a healthy weight in parents and children. Information collected during Phase I will inform the development of the skill-based cooking intervention. Once developed, the intervention will be refined with 6 primary caretakers of a child, who meet criteria for being overweight/obese during a testing phase. Conducting the intervention with at least six families will provide the opportunity for further refinement of intervention procedures. The results will be important to demonstrate feasibility for a future pilot randomized controlled trial that will test the impact of a skill-based cooking intervention compared to a standard cooking demonstration where recipes are simply provided to families.
- Conditions
- Obesity
- Being tested
- Cooking
- Keywords
- cooking skills, eating out, foods prepared away from home
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CookingOther
The aim is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and parent/child weight status.
| Study group | Role | What they receive |
|---|---|---|
| Cooking | Other | A skill-based cooking intervention for caretakers of an overweight/obese child aged 3-10 years. Receives: Other: Cooking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Intake (Phase II only)
Caregivers will be asked to complete a 7-day dietary record of what they and their child eat at the evening meal. For each evening meal, the caretaker will be asked to describe the meal type (fast food, restaurant, pre-prepared frozen meal, or home prepared); the specific foods and drinks consumed, and the amount consumed by the child. Data from dietary records will be input into Nutrition Data System for Research (NDSR) software and analyzed for energy intake, percent energy from fat, and food groups (fruits, vegetables, grains, proteins, dairy) from the evening meal. Foods prepared away from home will be classified based on caretaker indication of fast food, restaurant, pre-prepared frozen meal, or home prepared on the dietary record.
Measured: 0 and 10 weeks
Secondary outcomes (5)
Caretaker Attitudes and Confidence
Caretakers will report ease of providing foods prepared away from home (i.e., pre-prepared frozen meals, restaurant food, fast food, take-out) for an evening meal, ease of providing a home prepared evening meal, and their confidence with meal preparation using a 100-mm visual analog scale (VAS). Further caretakers will rate their ability, enjoyment of cooking and desire to cook on a 100-mm VAS.
Measured: 0 and 10 weeks
Food Costs
Caretakers will be provided with four visual images with each image showing one adult evening meal and two child evening meals. Caretaker will record the total cost of the meals shown in each image.
Measured: 0 and 10 weeks
Portions
Caretakers will be provided with visual images of foods in different portion amounts and asked to identify which image best represents the amount their child would be served for dinner. Caretakers will also identify the images that best represent the amount they would serve themselves for dinner.
Measured: 0 and 10 weeks
Dinner Choices
Caretakers will complete a 10-question, open-ended questionnaire that solicits information related to choices of foods prepared away from home and foods prepared at home.
Measured: 0 and 10 weeks
Anthropometrics
Height and weight will be measured using standard procedures.
Measured: 0 adn 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202733
- Sponsor's protocol ID
- 2013-5379
- Other IDs
- Eating Out
- Status last verified
- Jul 2015
- First submitted
- 25 Jul 2014
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Caretaker Cooking Skills Intervention to Reduce Eating Out
- ClinicalTrials.gov ID
- NCT02202733
- Acronym / sponsor ID
- 2013-5379
- Conditions
- Obesity
- Keywords
- cooking skills, eating out, foods prepared away from home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the study is to use an iterative process to develop and refine a skill-based cooking intervention to decrease the consumption of energy from foods prepared away from home for evening meals, decrease energy intake, and promote a healthy weight in parents and children aged 3-10 years.
Detailed description
Phase I. Conduct 2-4 focus groups with 6-10 caretaker, who report eating foods prepared away from home ≥3 times per week, per group to gain insight into current eating behaviors of foods prepared away from home, current perceptions about a home prepared evening meal, and barriers to preparing evening meals at home. Information gathered during Phase I will be used to inform intervention development in Phase II.
Phase II. Develop, refine, and manualize a skill-based cooking intervention for overweight/obese caretakers of a child aged 3-10 years. The aim of Phase II is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and promote a healthy weight in parents and children. Information collected during Phase I will inform the development of the skill-based cooking intervention. Once developed, the intervention will be refined with 6 primary caretakers of a child, who meet criteria for being overweight/obese during a testing phase. Conducting the intervention with at least six families will provide the opportunity for further refinement of intervention procedures. The results will be important to demonstrate feasibility for a future pilot randomized controlled trial that will test the impact of a skill-based cooking intervention compared to a standard cooking demonstration where recipes are simply provided to families.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cooking | Other | Other: CookingA skill-based cooking intervention for caretakers of an overweight/obese child aged 3-10 years. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- be ≥18 years of age
- have a child between the ages of 3 and 10 years-old
- report being the primary caretaker and have the primary feeding responsibility of the child for dinner/supper
- able to read, speak, and understand English
- have transportation to the Medical Center
Key exclusion criteria (2 listed)
- the caretaker or child is currently participating in a weight loss program and/or taking weight loss medication
- have a medical condition known to promote growth (e.g., Prader-Willi syndrome, Cushing's syndrome) or had gastric bypass surgery.
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 |
|---|---|---|
| CookingThe aim is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and parent/child weight status. | Other | Cooking |
Primary outcome
Dietary Intake (Phase II only)
Time frame: 0 and 10 weeks
Caregivers will be asked to complete a 7-day dietary record of what they and their child eat at the evening meal. For each evening meal, the caretaker will be asked to describe the meal type (fast food, restaurant, pre-prepared frozen meal, or home prepared); the specific foods and drinks consumed, and the amount consumed by the child. Data from dietary records will be input into Nutrition Data System for Research (NDSR) software and analyzed for energy intake, percent energy from fat, and food groups (fruits, vegetables, grains, proteins, dairy) from the evening meal. Foods prepared away from home will be classified based on caretaker indication of fast food, restaurant, pre-prepared frozen meal, or home prepared on the dietary record.
5 secondary outcomes
Caretaker Attitudes and Confidence
Time frame: 0 and 10 weeks
Food Costs
Time frame: 0 and 10 weeks
Portions
Time frame: 0 and 10 weeks
Dinner Choices
Time frame: 0 and 10 weeks
Anthropometrics
Time frame: 0 adn 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking in people with Obesity, run by Children's Hospital Medical Center, Cincinnati 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 18 inclusion and 2 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 14 Jul 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dietary Intake (Phase II only) (time frame: 0 and 10 weeks). 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 14 Jul 2015.