Simple Suppers Scale-up (S3) | NCT02923050

Studies
Simple Suppers Scale-up (S3)

NCT02923050

Sponsor

Ohio State University

Status

Completed

Last Update Posted

Oct 4, 2016Estimated

Enrollment

223Actual

Phase

Not Applicable

Conditions

Childhood Obesity

Interventions

Simple Suppers

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Sep 28, 2016

First Submission Date that Met QC Criteria

Oct 1, 2016

First Posted Date

Oct 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2016

Last Update Posted Date

Oct 4, 2016Estimated

Name	Class
Cardinal Health	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

223Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Waitlist control	No Intervention
10-week family meals program	Experimental		Behavioral: Simple Suppers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simple Suppers	Behavioral	Theory-based 10-week family meals program	10-week family meals program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Child standardized body mass index (BMI)		Change from baseline child BMI at 10 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31823753	Derived	Gunther C, Rogers C, Holloman C, Hopkins LC, Anderson SE, Miller CK, Copeland KA, Dollahite JS, Pratt KJ, Webster A, Labyk AN, Penicka C. Child diet and health outcomes of the simple suppers program: a 10-week, 2-group quasi-experimental family meals trial. BMC Public Health. 2019 Dec 10;19(1):1657. doi: 10.1186/s12889-019-7930-7.
28069006

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders