Diet HabitNCT04330235
Evaluating a Healthy Restaurant Kids Meals Policy
An observational study of Diet Habit, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in United States.
Trial summary
More than a dozen municipalities have passed healthy default kids' beverage policies. These policies seek to reduce child consumption of sugar-sweetened beverages (SSBs) by requiring that restaurants serve only healthy beverages (e.g., water, milk, or 100% juice) instead of SSBs as the default choice with children's… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- Healthy Default Kids' Beverage Policy
- How many people
- 3,480 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Oct 2019to 18 Jul 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents/legal guardians of children 2-10 years of age will be recruited from fast-food restaurants in Philadelphia, northern New Jersey, and New York City that operate more than one location in both the intervention and control areas, serve kids' meals, and are not compliant with the healthy default kids' beverage policy at baseline.
Who may be able to join
- Adult 18 years of age or older
- Parent or legal guardian of a child 2-10 years of age
- Purchasing at least one food or beverage item for the child at the restaurant (if purchasing foods or beverages for multiple children, only items purchased for the youngest child 2-10 years of age will be included)
- Able to speak and understand English or Spanish
- Additional criteria for dietary recalls:
- Parent or legal guardian 18 years of age or older is present for the recall
- If child for whom the restaurant meal was purchased is 6 years of age or older, child is present for the recall
- If child for whom the restaurant meal was purchased is 9 years of age or older, the child is present for the recall and is able to speak and understand English or Spanish
Who cannot join
- Younger than 18 years of age
- Is not a parent or legal guardian to a child 2-10 years of age
- Is not purchasing one or more food or beverage items for the child at the restaurant
- Does not speak or understand English or Spanish
- Additional criteria for dietary recalls:
- Parent or legal guardian is not present for the recall
- The restaurant meal was purchased for a child 6 years of age or older, who is not present for the recall
- Child 9 years of age or older, for whom the restaurant meal was purchased, is not able to speak or understand English or Spanish
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Minnesota
Minneapolis, Minnesota, 55454-1087
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
RTI, International
Research Triangle Park, North Carolina, 27709
About this study
More than a dozen municipalities have passed healthy default kids' beverage policies. These policies seek to reduce child consumption of sugar-sweetened beverages (SSBs) by requiring that restaurants serve only healthy beverages (e.g., water, milk, or 100% juice) instead of SSBs as the default choice with children's meals in restaurants. These policies have potential to meaningfully reduce child SSB consumption. However, there are significant gaps in our knowledge of the effects of healthy default beverage policies on children's health. This study uses a natural experiment to evaluate the effects of a healthy default beverage policy in two U.S. cities, New York City and Philadelphia, on children's fast-food restaurant meal orders and dietary intake. The primary hypothesis is that the policy will reduce children's SSB purchases and consumption, reduce children's total caloric intake, and improve diet quality at the fast-food restaurant meal and on the day of the restaurant meal.
Read the detailed description
This study uses a quasi-experimental approach to evaluate the effects of a healthy default kids' beverage policy on children's fast-food restaurant meal purchases and dietary intake. Annotated receipt and survey data will be collected from parents purchasing a food or beverage for a child 2-10 years of age at fast-food restaurants. Eligible participants will be asked to participate in a telephone dietary recall the following day. Data will be collected from a repeated cross-section of children in two intervention cities implementing a healthy default kids' beverage policy (New York City and Philadelphia) and a control area not implementing the policy (northern New Jersey) before the policy is implemented and after the policy goes into effect. A difference-in-differences analytic approach will be used to compare the change in children's fast-food restaurant meal orders and dietary intake pre- to post-implementation in the intervention versus control groups. A Holm-Bonferroni correction for multiple comparisons will be applied to p-values for secondary outcomes.
- Conditions
- Diet Habit
- Being tested
- Healthy Default Kids' Beverage Policy
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Default Kids' Beverage PolicyOther
Also called Healthy Restaurant Kids' Meals Policy, Healthy Default Beverage Policy, Healthy Default Beverage Law, Healthy-by-Default Policy
The healthy default kids' beverage policy requires that all restaurants serve only healthy beverages (water, milk, or 100% juice) instead of sugary beverages as the default beverage with children's meals. The policy has been enacted in New York City and Philadelphia and will go into effect in April 2020.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Children 2-10 years of age dining at fast-food restaurants in New York City and Philadelphia, where a healthy default beverage policy will be enacted. Receives: Other: Healthy Default Kids' Beverage Policy | |
| Control Group | Children 2-10 years of age dining at fast-food restaurants in northern New Jersey, where a healthy default beverage policy will not be enacted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline total caloric intake at 24 months
Total calories consumed by the child on the day of the restaurant meal
Measured: 24 months
Secondary outcomes (13)
Change from baseline calories consumed from sugar-sweetened beverages at 24 months
Calories consumed by the child from sugar-sweetened beverages on the day of the restaurant meal
Measured: 24 months
Change from baseline calories consumed from healthy beverages at 24 months
Calories consumed by the child from healthy beverages as defined by NYC/Philadelphia law on the day of the restaurant meal
Measured: 24 months
Change from baseline calories consumed from other unhealthy beverages at 24 months
Calories consumed by the child from unhealthy beverages as defined by NYC/Philadelphia law, excluding sugar-sweetened beverages, on the day of the restaurant meal
Measured: 24 months
Change from baseline Healthy Eating Index 2015 score at 24 months
Child's diet quality, measured using the Healthy Eating Index 2015, on the day of the restaurant meal. The Healthy Eating Index 2015 measures how well a diet aligns with the Dietary Guidelines for Americans. It is measured on a scale from 0-100, where higher scores indicate a healthier diet.
Measured: 24 months
Change from baseline total caloric intake during the restaurant meal at 24 months
Total calories consumed by the child during the restaurant eating occasion
Measured: 24 months
Change from baseline calories consumed from sugar-sweetened beverages during the restaurant meal at 24 months
Calories consumed by the child from sugar-sweetened beverages during the restaurant eating occasion
Measured: 24 months
Change from baseline calories consumed from healthy beverages during the restaurant meal at 24 months
Calories consumed by the child from healthy beverages as defined by NYC/Philadelphia law during the restaurant eating occasion
Measured: 24 months
Change from baseline calories consumed from other unhealthy beverages during the restaurant meal at 24 months
Calories consumed by the child from unhealthy beverages as defined by NYC/Philadelphia law, excluding sugar-sweetened beverages, during the restaurant eating occasion
Measured: 24 months
Change from baseline Healthy Eating Index 2015 score during the restaurant meal at 24 months
Child's diet quality, measured using the Healthy Eating Index 2015, during the restaurant eating occasion. The Healthy Eating Index 2015 measures how well a diet aligns with the Dietary Guidelines for Americans. It is measured on a scale from 0-100, where higher scores indicate a healthier diet.
Measured: 24 months
Change from baseline fluid ounces of sugar-sweetened beverages purchased at 24 months
Fluid ounces of sugar-sweetened beverages purchased for the child at the restaurant
Measured: 24 months
Change from baseline fluid ounces of healthy beverages purchased at 24 months
Fluid ounces of healthy beverages as defined by NYC/Philadelphia law purchased for the child at the restaurant
Measured: 24 months
Change from baseline fluid ounces of other unhealthy beverages purchased at 24 months
Fluid ounces of unhealthy beverages as defined by NYC/Philadelphia law, excluding sugar-sweetened beverages, purchased for the child at the restaurant
Measured: 24 months
Change from baseline frequency of dining at fast food restaurants at 24 months
Number of lunch or dinner meals from fast food restaurants for the child in the past week
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start13 Oct 2019
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), University of Pennsylvania, Harvard Pilgrim Health Care, University of Minnesota, RTI International, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Alyssa Moran, ScD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthAngie Cradock, ScD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330235
- Sponsor's protocol ID
- HDB-NYC
- Other IDs
- 1R01HD100983-01
- Status last verified
- Sep 2022
- First submitted
- 16 Jan 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Healthy Restaurant Kids Meals Policy
- ClinicalTrials.gov ID
- NCT04330235
- Acronym / sponsor ID
- HDB-NYC
- Conditions
- Diet Habit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,480 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), University of Pennsylvania, Harvard Pilgrim Health Care, University of Minnesota, RTI International, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Oct 2019 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 1 Apr 2020 (actual)
- 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.
More than a dozen municipalities have passed healthy default kids' beverage policies. These policies seek to reduce child consumption of sugar-sweetened beverages (SSBs) by requiring that restaurants serve only healthy beverages (e.g., water, milk, or 100% juice) instead of SSBs as the default choice with children's meals in restaurants. These policies have potential to meaningfully reduce child SSB consumption. However, there are significant gaps in our knowledge of the effects of healthy default beverage policies on children's health. This study uses a natural experiment to evaluate the effects of a healthy default beverage policy in two U.S. cities, New York City and Philadelphia, on children's fast-food restaurant meal orders and dietary intake. The primary hypothesis is that the policy will reduce children's SSB purchases and consumption, reduce children's total caloric intake, and improve diet quality at the fast-food restaurant meal and on the day of the restaurant meal.
Detailed description
This study uses a quasi-experimental approach to evaluate the effects of a healthy default kids' beverage policy on children's fast-food restaurant meal purchases and dietary intake. Annotated receipt and survey data will be collected from parents purchasing a food or beverage for a child 2-10 years of age at fast-food restaurants. Eligible participants will be asked to participate in a telephone dietary recall the following day. Data will be collected from a repeated cross-section of children in two intervention cities implementing a healthy default kids' beverage policy (New York City and Philadelphia) and a control area not implementing the policy (northern New Jersey) before the policy is implemented and after the policy goes into effect. A difference-in-differences analytic approach will be used to compare the change in children's fast-food restaurant meal orders and dietary intake pre- to post-implementation in the intervention versus control groups. A Holm-Bonferroni correction for multiple comparisons will be applied to p-values for secondary outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: Healthy Default Kids' Beverage PolicyChildren 2-10 years of age dining at fast-food restaurants in New York City and Philadelphia, where a healthy default beverage policy will be enacted. |
| Control Group | – | –Children 2-10 years of age dining at fast-food restaurants in northern New Jersey, where a healthy default beverage policy will not be enacted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents/legal guardians of children 2-10 years of age will be recruited from fast-food restaurants in Philadelphia, northern New Jersey, and New York City that operate more than one location in both the intervention and control areas, serve kids' meals, and are not compliant with the healthy default kids' beverage policy at baseline.
Key inclusion criteria (8 listed)
- Adult 18 years of age or older
- Parent or legal guardian of a child 2-10 years of age
- Purchasing at least one food or beverage item for the child at the restaurant (if purchasing foods or beverages for multiple children, only items purchased for the youngest child 2-10 years of age will be included)
- Able to speak and understand English or Spanish
- Parent or legal guardian 18 years of age or older is present for the recall
Key exclusion criteria (8 listed)
- Younger than 18 years of age
- Is not a parent or legal guardian to a child 2-10 years of age
- Is not purchasing one or more food or beverage items for the child at the restaurant
- Does not speak or understand English or Spanish
- Parent or legal guardian is not present for the recall
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 |
|---|---|---|
| Healthy Default Kids' Beverage PolicyAlso: Healthy Restaurant Kids' Meals Policy, Healthy Default Beverage Policy, Healthy Default Beverage Law, Healthy-by-Default PolicyThe healthy default kids' beverage policy requires that all restaurants serve only healthy beverages (water, milk, or 100% juice) instead of sugary beverages as the default beverage with children's meals. The policy has been enacted in New York City and Philadelphia and will go into effect in April 2020. | Other | Intervention Group |
Primary outcome
Change from baseline total caloric intake at 24 months
Time frame: 24 months
Total calories consumed by the child on the day of the restaurant meal
13 secondary outcomes
Change from baseline calories consumed from sugar-sweetened beverages at 24 months
Time frame: 24 months
Change from baseline calories consumed from healthy beverages at 24 months
Time frame: 24 months
Change from baseline calories consumed from other unhealthy beverages at 24 months
Time frame: 24 months
Change from baseline Healthy Eating Index 2015 score at 24 months
Time frame: 24 months
Change from baseline total caloric intake during the restaurant meal at 24 months
Time frame: 24 months
Change from baseline calories consumed from sugar-sweetened beverages during the restaurant meal at 24 months
Time frame: 24 months
Change from baseline calories consumed from healthy beverages during the restaurant meal at 24 months
Time frame: 24 months
Change from baseline calories consumed from other unhealthy beverages during the restaurant meal at 24 months
Time frame: 24 months
Change from baseline Healthy Eating Index 2015 score during the restaurant meal at 24 months
Time frame: 24 months
Change from baseline fluid ounces of sugar-sweetened beverages purchased at 24 months
Time frame: 24 months
Change from baseline fluid ounces of healthy beverages purchased at 24 months
Time frame: 24 months
Change from baseline fluid ounces of other unhealthy beverages purchased at 24 months
Time frame: 24 months
Change from baseline frequency of dining at fast food restaurants at 24 months
Time frame: 24 months
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 28 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Diet Habit
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
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.
Alyssa Moran, ScD principal investigator
Johns Hopkins Bloomberg School of Public Health
Angie Cradock, ScD principal investigator
Harvard School of Public Health (HSPH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit, run by Johns Hopkins Bloomberg School of Public Health at 3 sites 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 8 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change from baseline total caloric intake at 24 months (time frame: 24 months). 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 28 Sep 2022.