NCT02923050

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

September 28, 2016

Last Update Submit

October 1, 2016

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

  • Child standardized body mass index (BMI)

    Change from baseline child BMI at 10 weeks

Study Arms (2)

Waitlist control

NO INTERVENTION

10-week family meals program

EXPERIMENTAL
Behavioral: Simple Suppers

Interventions

Simple SuppersBEHAVIORAL

Theory-based 10-week family meals program

10-week family meals program

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Family member: Following a restrictive or therapeutic diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 31823753DERIVED

  • 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.

    PMID: 28069006DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 4, 2016

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share