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Simple Suppers Scale-up (S3)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Simple Suppers
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity

Eligibility Criteria

4 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Waitlist control

    10-week family meals program

    Arm Description

    Outcomes

    Primary Outcome Measures

    Child standardized body mass index (BMI)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2016
    Last Updated
    October 1, 2016
    Sponsor
    Ohio State University
    Collaborators
    Cardinal Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02923050
    Brief Title
    Simple Suppers Scale-up (S3)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University
    Collaborators
    Cardinal Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    223 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Waitlist control
    Arm Type
    No Intervention
    Arm Title
    10-week family meals program
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Simple Suppers
    Intervention Description
    Theory-based 10-week family meals program
    Primary Outcome Measure Information:
    Title
    Child standardized body mass index (BMI)
    Time Frame
    Change from baseline child BMI at 10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31823753
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    28069006
    Citation
    Rogers C, Anderson SE, Dollahite JS, Hill TF, Holloman C, Miller CK, Pratt KJ, Gunther C. Methods and design of a 10-week multi-component family meals intervention: a two group quasi-experimental effectiveness trial. BMC Public Health. 2017 Jan 9;17(1):50. doi: 10.1186/s12889-016-3908-x.
    Results Reference
    derived

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    Simple Suppers Scale-up (S3)

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