Child OvernutritionCO180NCT03422926
ChildObesity180 - Social Marketing Campaign to Encourage Healthful Eating in Restaurants for Children
A study testing Social marketing campaign in people with Child Overnutrition, run by Tufts University.
Trial summary
The purpose of this study is to determine whether a messaging campaign affects the calories ordered for and consumed by children in a quick serve restaurant setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Overnutrition
- What is being tested?
- Social marketing campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,646 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent or legal guardian of a 4 - 12 year old child (who is present)
- Have not participated in the study before
- <<Intervention community only>> live, work, or frequently travel to community
Who cannot join
- -
About this study
The purpose of this study is to determine whether a messaging campaign affects the calories ordered for and consumed by children in a quick serve restaurant setting.
Read the detailed description
ChildObesity180 seeks to develop and implement a messaging campaign informed by evidence-based behavioral theory as well as perspectives from parents, children, and the restaurant industry. The campaign aims to help parents choose healthful options for their children when dining in the quick-serve restaurant setting. Aim 1 is campaign development. Aims 2 and 3 are assessment (i.e., Randomized controlled trial and revenue analysis). Hypotheses are that the messaging campaign will be associated with fewer calories ordered/consumed by children in the quick serve setting; and the campaign will not negatively impact quick serve restaurant revenue.
- Conditions
- Child Overnutrition
- Being tested
- Social marketing campaign
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social marketing campaignBehavioural
Messaging campaign designed to help mothers in choosing healthful options when dining out.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Social marketing messaging campaign Receives: Behavioral: Social marketing campaign |
| Control | No intervention | No messaging campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
kilocalories ordered
Receipt data will be used to determine what items were ordered for the parent and child, and kcals will be calculated using nutrition information from the restaurant and bomb calorimetry.
Measured: change from baseline to follow-up 3-5 months later
kilocalories consumed
Child plate waste will be collected, weighed and digitally imaged; a subset will be analyzed using bomb calorimetry.
Measured: change from baseline to follow-up 3-5 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
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 Child OvernutritionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,646 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina D Economos, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422926
- Sponsor's protocol ID
- PV1529
- Acronym
- CO180
- Status last verified
- Jan 2018
- First submitted
- 24 Apr 2017
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hennessy E, Shonkoff E, Harelick L, Bakun P, Chui K, Roberts S, Folta S, Goldberg J, Economos CD. The impact of a community social marketing campaign on children's meal orders and consumption: main outcomes from a group randomised controlled trial. Public Health Nutr. 2023 Jan;26(1):256-261. doi: 10.1017/S136898002200163X. Epub 2022 Aug 8.
PubMed 35938500
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChildObesity180 - Social Marketing Campaign to Encourage Healthful Eating in Restaurants for Children
- ClinicalTrials.gov ID
- NCT03422926
- Acronym / sponsor ID
- CO180 / PV1529
- Conditions
- Child Overnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,646 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Feb 2018 (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.
The purpose of this study is to determine whether a messaging campaign affects the calories ordered for and consumed by children in a quick serve restaurant setting.
Detailed description
ChildObesity180 seeks to develop and implement a messaging campaign informed by evidence-based behavioral theory as well as perspectives from parents, children, and the restaurant industry. The campaign aims to help parents choose healthful options for their children when dining in the quick-serve restaurant setting. Aim 1 is campaign development. Aims 2 and 3 are assessment (i.e., Randomized controlled trial and revenue analysis). Hypotheses are that the messaging campaign will be associated with fewer calories ordered/consumed by children in the quick serve setting; and the campaign will not negatively impact quick serve restaurant revenue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Social marketing campaignSocial marketing messaging campaign |
| Control | No intervention | –No messaging campaign |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent or legal guardian of a 4 - 12 year old child (who is present)
- Have not participated in the study before
- <<Intervention community only>> live, work, or frequently travel to community
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Social marketing campaignMessaging campaign designed to help mothers in choosing healthful options when dining out. | Behavioural | Intervention |
Primary outcome
kilocalories ordered
Time frame: change from baseline to follow-up 3-5 months later
Receipt data will be used to determine what items were ordered for the parent and child, and kcals will be calculated using nutrition information from the restaurant and bomb calorimetry.
kilocalories consumed
Time frame: change from baseline to follow-up 3-5 months later
Child plate waste will be collected, weighed and digitally imaged; a subset will be analyzed using bomb calorimetry.
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 6 Feb 2018.
- Derived from this study: PubMed 35938500Hennessy E, Shonkoff E, Harelick L, Bakun P, Chui K, Roberts S, Folta S, Goldberg J, Economos CD. The impact of a community social marketing campaign on children's meal orders and consumption: main outcomes from a group randomised controlled trial. Public Health Nutr. 2023 Jan;26(1):256-261. doi: 10.1017/S136898002200163X. Epub 2022 Aug 8.
- Individual participant dataSharing planned: No
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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.
Christina D Economos, PhD principal investigator
Tufts University
Questions about this trial
What is this clinical trial studying?
A study testing Social marketing campaign in people with Child Overnutrition, run by Tufts University.
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 3 inclusion and 1 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 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
kilocalories ordered (time frame: change from baseline to follow-up 3-5 months later). 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?
On the ClinicalTrials.gov record for NCT03422926, 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 6 Feb 2018.