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NCT02923050 Clinical Trial

Simple Suppers Scale-up (S3)

Childhood Obesity Clinical Trial

Official title:
Simple Suppers Scale-up (S3): an Expanded Pilot Study to Determine the Effectiveness of a Family Meals Intervention Aimed at Eliciting Positive Changes in Child Diet and Weight Status

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02923050
Other study ID # 2014B0494
Secondary ID
Status Completed
Phase N/A
First received September 28, 2016
Last updated October 1, 2016
Start date January 2015
Est. completion date July 2016

Study information
Verified date October 2016
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine effectiveness of a family meals intervention, Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight status.

Recruitment information / eligibility
Status Completed
Enrollment 223
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 10 Years
Eligibility Inclusion Criteria:

- Caregivers: Primary food preparer in the home; responsible for at least one child 4-10 years of age; speak English as the primary language in the home; lived in the U.S. for at least one year.

Exclusion Criteria:

- Family member: Following a restrictive or therapeutic diet.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Simple Suppers
Theory-based 10-week family meals program

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ohio State University Cardinal Health Foundation

Outcome
Type Measure Description Time frame Safety issue
Primary Child standardized body mass index (BMI) Change from baseline child BMI at 10 weeks No
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