Childhood ObesityKCRPNCT02511938
Kids' Choice Restaurant Program
A study testing Menu Only and Menu Plus intervention in people with Childhood Obesity, run by San Diego State University at 1 site in United States.
Trial summary
This study will introduce healthy child menu items into 8 independent full service restaurants in San Diego County. The restaurants will be assigned either to receive new, healthy kids' menu items or to receive the new menu items in addition to marketing materials and staff trainings to support promotion of these new… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Menu Only and Menu Plus intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Nov 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Restaurant dining parties having at least one adult 18 or older and one child in party who appears to be between the ages of 3--17 years
- Dining parties including no more than six people
- Party speaks English and/or Spanish
- At least 18 years of age
- Has worked at restaurant at least 4 months
- Works at least 20 hours per week for the restaurant
- Plans to continue working at the restaurant for at least 6 months
- Speaks and writes English and/or Spanish
Who cannot join
- Party does not speak English and/or Spanish
- Parties larger than six people
- For restaurant manager interviews:
Trial locations and contacts
1 site in 1 country.
United States1 site
SDSU Research Foundation
San Diego, California, 92182
About this study
Official title: Introducing Child Menus in Restaurants to Improve Access to Healthier Foods
This study will introduce healthy child menu items into 8 independent full service restaurants in San Diego County. The restaurants will be assigned either to receive new, healthy kids' menu items or to receive the new menu items in addition to marketing materials and staff trainings to support promotion of these new menu items. The primary outcome for the study is sales of kids' menu items. Additional customer observation and interview data will be collected, as well as manager interviews and restaurant environment assessments. Process evaluation measures will also evaluate the implementation of the intervention.
Read the detailed description
The purpose of the study is to assess the efficacy of an intervention to improve access to healthier foods by introducing or changing child menus in restaurants. We propose recruiting 8 independent full service restaurants, either with or without existing child menus. Recruitment will occur in waves of two restaurants per wave for a total of four waves. Restaurants will be matched on key criteria such as whether they have a child menu and restaurant size based on seating (categorized as small -to- medium or large). Matched restaurants will be randomized to either an 8--week menu--only intervention or a menu--plus intervention that will occur at the same time. The menu--only intervention will involve working with the restaurant to add new healthy child menu items to their menus. The menu--plus intervention will involve working with the restaurants to add new healthy child menu items tailored to their menus, along with promotional materials and restaurant employee trainings to encourage customers to select these menu items. Weekly detailed sales data (reported by menu item) at baseline for one month, ongoing in all restaurants during 8-week intervention, and for one month at post intervention for all restaurants will be gathered and serve as the primary outcome of interest. Additionally, biweekly observations and customer interviews in each restaurant during one month pre--intervention phase, over 8--week intervention period, and during one month post-intervention phase to capture how orders are placed and what is ordered and reported to be consumed by the child. We will also assess the feasibility and fidelity of the intervention using manager interview data (baseline and post--intervention), restaurants audits (baseline, once during the intervention, and at post--intervention), and process evaluation measures (weekly during 8-week intervention). The study is not designed to provide a direct benefit to the participants and no such benefits can be guaranteed; however, participants may learn more about current public health research and efforts to understand child ordering and consumption behaviors in restaurants. This study may benefit independent restaurants as the findings will contribute to designing evidence--based approaches to improving the nutritional quality of child menu offerings and will help researchers to understand ordering and consumption behaviors for children in restaurants. This study presents minimal risks to the participants.
- Conditions
- Childhood Obesity
- Being tested
- Menu Only, Menu Plus intervention
- Keywords
- childhood obesity, restaurant, away from home foods
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menu OnlyOther
Restaurants will collaborate with project to develop and introduce new healthy kid's menu items. Project will provide recipes, preparation support, nutritional information, and printed menus to restaurants.
Menu Plus interventionOther
Restaurants will collaborate with project to develop and introduce new healthy kid's menu items. Project will provide recipes, preparation support, nutritional information, and printed menus to restaurants. In addition, project will provide promotional materials and brief restaurant staff trainings to promote the new menu.
| Study group | Role | What they receive |
|---|---|---|
| Menu Only intervention | Experimental | Restaurants will receive a new healthy kids' menu Receives: Other: Menu Only |
| Menu Plus Intervention | Experimental | Restaurants will receive a new healthy kids' menu, supporting marketing materials, and brief trainings for customer service staff and kitchen staff to support and promote the new menu items. Receives: Other: Menu Plus intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sales ($) of kids' menu items
Change in weekly sales ($) of kids' menu items as a proportion of total restaurant sales between baseline, intervention period, and post-intervention
Measured: weekly throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
Secondary outcomes (1)
Customer observations/interviews
change in child customer ordering behavior, decision making, and consumption between baseline, intervention period, and post-intervention
Measured: every other week throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guadalupe X. Ayala, San Diego State University
- Investigators
- Guadalupe X Ayala, PhD, MPH, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511938
- Sponsor's protocol ID
- R21HD071324
- Acronym
- KCRP
- Status last verified
- Apr 2017
- First submitted
- 21 Jul 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ayala GX, Castro IA, Pickrel JL, Williams CB, Lin SF, Madanat H, Jun HJ, Zive M. A restaurant-based intervention to promote sales of healthy children's menu items: the Kids' Choice Restaurant Program cluster randomized trial. BMC Public Health. 2016 Mar 10;16:250. doi: 10.1186/s12889-016-2892-5.
PubMed 26965639
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing Child Menus in Restaurants to Improve Access to Healthier Foods
- ClinicalTrials.gov ID
- NCT02511938
- Acronym / sponsor ID
- KCRP / R21HD071324
- Conditions
- Childhood Obesity
- Keywords
- childhood obesity, restaurant, away from home foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Jul 2015 (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.
This study will introduce healthy child menu items into 8 independent full service restaurants in San Diego County. The restaurants will be assigned either to receive new, healthy kids' menu items or to receive the new menu items in addition to marketing materials and staff trainings to support promotion of these new menu items. The primary outcome for the study is sales of kids' menu items. Additional customer observation and interview data will be collected, as well as manager interviews and restaurant environment assessments. Process evaluation measures will also evaluate the implementation of the intervention.
Detailed description
The purpose of the study is to assess the efficacy of an intervention to improve access to healthier foods by introducing or changing child menus in restaurants. We propose recruiting 8 independent full service restaurants, either with or without existing child menus. Recruitment will occur in waves of two restaurants per wave for a total of four waves. Restaurants will be matched on key criteria such as whether they have a child menu and restaurant size based on seating (categorized as small -to- medium or large). Matched restaurants will be randomized to either an 8--week menu--only intervention or a menu--plus intervention that will occur at the same time. The menu--only intervention will involve working with the restaurant to add new healthy child menu items to their menus. The menu--plus intervention will involve working with the restaurants to add new healthy child menu items tailored to their menus, along with promotional materials and restaurant employee trainings to encourage customers to select these menu items. Weekly detailed sales data (reported by menu item) at baseline for one month, ongoing in all restaurants during 8-week intervention, and for one month at post intervention for all restaurants will be gathered and serve as the primary outcome of interest. Additionally, biweekly observations and customer interviews in each restaurant during one month pre--intervention phase, over 8--week intervention period, and during one month post-intervention phase to capture how orders are placed and what is ordered and reported to be consumed by the child. We will also assess the feasibility and fidelity of the intervention using manager interview data (baseline and post--intervention), restaurants audits (baseline, once during the intervention, and at post--intervention), and process evaluation measures (weekly during 8-week intervention). The study is not designed to provide a direct benefit to the participants and no such benefits can be guaranteed; however, participants may learn more about current public health research and efforts to understand child ordering and consumption behaviors in restaurants. This study may benefit independent restaurants as the findings will contribute to designing evidence--based approaches to improving the nutritional quality of child menu offerings and will help researchers to understand ordering and consumption behaviors for children in restaurants. This study presents minimal risks to the participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menu Only intervention | Experimental | Other: Menu OnlyRestaurants will receive a new healthy kids' menu |
| Menu Plus Intervention | Experimental | Other: Menu Plus interventionRestaurants will receive a new healthy kids' menu, supporting marketing materials, and brief trainings for customer service staff and kitchen staff to support and promote the new menu items. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Restaurant dining parties having at least one adult 18 or older and one child in party who appears to be between the ages of 3--17 years
- Dining parties including no more than six people
- Party speaks English and/or Spanish
- At least 18 years of age
- Has worked at restaurant at least 4 months
Key exclusion criteria (3 listed)
- Party does not speak English and/or Spanish
- Parties larger than six people
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 |
|---|---|---|
| Menu OnlyRestaurants will collaborate with project to develop and introduce new healthy kid's menu items. Project will provide recipes, preparation support, nutritional information, and printed menus to restaurants. | Other | Menu Only intervention |
| Menu Plus interventionRestaurants will collaborate with project to develop and introduce new healthy kid's menu items. Project will provide recipes, preparation support, nutritional information, and printed menus to restaurants. In addition, project will provide promotional materials and brief restaurant staff trainings to promote the new menu. | Other | Menu Plus Intervention |
Primary outcome
Sales ($) of kids' menu items
Time frame: weekly throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
Change in weekly sales ($) of kids' menu items as a proportion of total restaurant sales between baseline, intervention period, and post-intervention
1 secondary outcome
Customer observations/interviews
Time frame: every other week throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
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 26 Apr 2017.
- Derived from this study: PubMed 26965639Ayala GX, Castro IA, Pickrel JL, Williams CB, Lin SF, Madanat H, Jun HJ, Zive M. A restaurant-based intervention to promote sales of healthy children's menu items: the Kids' Choice Restaurant Program cluster randomized trial. BMC Public Health. 2016 Mar 10;16:250. doi: 10.1186/s12889-016-2892-5.
- Individual participant dataSharing planned: Undecided
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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.
Guadalupe X Ayala, PhD, MPH principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menu Only and Menu Plus intervention in people with Childhood Obesity, run by San Diego State University 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 8 inclusion and 3 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 26 Apr 2017. 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?
Sales ($) of kids' menu items (time frame: weekly throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511938, which also lists 1 linked publication.
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 26 Apr 2017.