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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03422926
Other study ID # PV1529
Secondary ID
Status Completed
Phase N/A
First received April 24, 2017
Last updated January 30, 2018
Start date October 2015
Est. completion date October 2016

Study information

Verified date January 2018
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2646
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

Study Design


Intervention

Behavioral:
Social marketing campaign
Messaging campaign designed to help mothers in choosing healthful options when dining out.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tufts University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. change from baseline to follow-up 3-5 months later
Primary kilocalories consumed Child plate waste will be collected, weighed and digitally imaged; a subset will be analyzed using bomb calorimetry. change from baseline to follow-up 3-5 months later
See also
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Completed NCT02914002 - Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings N/A
Completed NCT02258802 - Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings N/A