NCT03422926

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,646

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
Last Updated

February 6, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

April 24, 2017

Last Update Submit

January 30, 2018

Conditions

Child Overnutrition

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Social marketing messaging campaign

Behavioral: Social marketing campaign

Control

NO INTERVENTION

No messaging campaign

Interventions

Social marketing campaignBEHAVIORAL

Messaging campaign designed to help mothers in choosing healthful options when dining out.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35938500DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Christina D Economos, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

February 6, 2018

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

February 6, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share