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Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Home Plate

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Nutrition, Home Food Preparation, Home Food Environment, Peer Mentoring, Early Head Start, Cooking, Diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: mentees

English-speaking
Able to give informed consent.
Legal guardian and caregiver of at least one child, age 1-3 years

Inclusion Criteria: children

1-3 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.

Inclusion Criteria: peer mentors

Eligible peer mentors should meet the inclusion criteria set forth above for mentees. (Children of peer mentors will not be eligible for this 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.

Exclusion Criteria

Caregivers and children not meeting the inclusion criteria above.
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.

Sites / Locations

The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intervention

Delayed Entry Control

Arm Description

Behavioral: Home Plate intervention

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Home Food Preparation Practices

Adult participants will complete surveys to assess the foods they usually prepare at home, as well as the time, energy, and confidence they have to prepare meals for their household.

Home Food Environment

Adult participants will complete surveys to assess the foods currently available in their homes, how they feel about managing food-related tasks, and the interactions they have with their child(ren) regarding food and eating.

Household Routines

Adult participants will complete surveys to assess their household routines related to activities such as sleep, physical activity, and screen time.

Emotional and Family Health

Adult participants will complete surveys to assess the their emotional health and the health of their families.

Body mass index

Heights and weights will be measured by trained study staff and will be used to calculate body mass index (BMI) of adult and child participants.

Dietary Energy Density (Adult Participants)

24-hour dietary recalls will be collected by trained study staff from adult study participants. 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 dietary energy density.

Diet Quality

In addition to dietary energy density, 24-hour dietary recall data will be used to calculate both child and adult study participants' intake of fruits, vegetables, whole grains, and added sugars.

Full Information

NCT ID

NCT02458833

First Posted

May 28, 2015

Last Updated

April 22, 2019

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT02458833

Brief Title

Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers

Official Title

Home Plate: A Randomized Controlled Trial of a Community-Engaged Intervention to Improve Home Food Preparation Practices and Health During Early Childhood

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Barriers to healthy eating and active living are at the heart of the obesity epidemic. This study focuses on a key factor underlying healthy eating: home food preparation. 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. The investigators will partner with community-based organizations serving families with children ages 1 to 3 years in West Philadelphia aiming specifically to: Test the intervention's effect on diet and physical health. Hypothesis 1: The intervention group will have improved home food preparation practices and a healthier diet compared to the control group. Test the intervention's effect on family health. Hypothesis 2: The intervention group will report improved parenting skills and more hopeful patterns of thinking. Identify factors present at baseline and during engagement with the intervention that distinguish intervention participants who have improved diet, physical health, and family health from those who do not.

6. Conditions and Keywords

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

Obesity

Keywords

Obesity, Nutrition, Home Food Preparation, Home Food Environment, Peer Mentoring, Early Head Start, Cooking, Diet

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Behavioral: Home Plate intervention

Arm Title

Delayed Entry Control

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Home Plate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Dietary Energy Density (Child Participants)

Description

Time Frame

19-30 weeks from baseline

Secondary Outcome Measure Information:

Title

Home Food Preparation Practices

Description

Adult participants will complete surveys to assess the foods they usually prepare at home, as well as the time, energy, and confidence they have to prepare meals for their household.

Time Frame

19-30 weeks from baseline

Title

Home Food Environment

Description

Time Frame

19-30 weeks from baseline

Title

Household Routines

Description

Adult participants will complete surveys to assess their household routines related to activities such as sleep, physical activity, and screen time.

Time Frame

19-30 weeks from baseline

Title

Emotional and Family Health

Description

Adult participants will complete surveys to assess the their emotional health and the health of their families.

Time Frame

19-30 weeks from baseline

Title

Body mass index

Description

Heights and weights will be measured by trained study staff and will be used to calculate body mass index (BMI) of adult and child participants.

Time Frame

19-30 weeks from baseline

Title

Dietary Energy Density (Adult Participants)

Description

Time Frame

19-30 weeks from baseline

Title

Diet Quality

Description

In addition to dietary energy density, 24-hour dietary recall data will be used to calculate both child and adult study participants' intake of fruits, vegetables, whole grains, and added sugars.

Time Frame

19-30 weeks from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: mentees English-speaking Able to give informed consent. Legal guardian and caregiver of at least one child, age 1-3 years Inclusion Criteria: children 1-3 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. Inclusion Criteria: peer mentors Eligible peer mentors should meet the inclusion criteria set forth above for mentees. (Children of peer mentors will not be eligible for this 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. Exclusion Criteria Caregivers and children not meeting the inclusion criteria above. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Senbagam Virudachalam, MD, MSHP

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers

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