NCT02458833

Brief Summary

This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2017

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

May 28, 2015

Last Update Submit

April 22, 2019

Conditions

Keywords

ObesityNutritionHome Food PreparationHome Food EnvironmentPeer MentoringEarly Head StartCookingDiet

Outcome Measures

Primary Outcomes (1)

  • Dietary Energy Density (Child Participants)

    Child participants' 24-hour dietary recalls will be collected by trained study staff from adult caregivers. 24-hour dietary recalls will be collected on a minimum of 2 and a maximum of 3 separate days. The results will then be used to calculate the energy density of the child's diet.

    19-30 weeks from baseline

Secondary Outcomes (7)

  • Home Food Preparation Practices

    19-30 weeks from baseline

  • Home Food Environment

    19-30 weeks from baseline

  • Household Routines

    19-30 weeks from baseline

  • Emotional and Family Health

    19-30 weeks from baseline

  • Body mass index

    19-30 weeks from baseline

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Home Plate intervention

Behavioral: Home Plate

Delayed Entry Control

EXPERIMENTAL

This Arm will receive the Home Plate intervention 3 months after the Intervention Arm completes the intervention.

Behavioral: Home Plate

Interventions

Home PlateBEHAVIORAL

Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children. Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.

Delayed Entry ControlIntervention

Eligibility Criteria

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

You may qualify if:

  • English-speaking
  • Able to give informed consent.
  • Legal guardian and caregiver of at least one child, age 1-3 years
  • year old children of mentee primary caregivers enrolled in the study
  • If a mentee caregiver has more than one child, then all their eligible children (ages 1-3 years) will be enrolled in the study.
  • In addition,
  • The study team will decide which participants will be invited to be peer mentors, based on attributes including interest, leadership ability, and home food preparation skills.

You may not qualify if:

  • Caregivers who are pregnant at the time of enrollment.
  • Caregivers or children with a medical condition that significantly affects their diet or eating habits. (The study team will ask during the time of recruitment if subjects or their children have a medical condition that significantly affects diet or eating habits.)
  • Subjects who, in the opinion of the Investigator, may be unable to participate in the study schedules or procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Senbagam Virudachalam, MD, MSHP

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 1, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 13, 2017

Last Updated

April 24, 2019

Record last verified: 2019-04

Locations