NCT01710423

Brief Summary

This study aims to test the effectiveness of a community-located, 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
47

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable obesity

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

October 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

October 17, 2012

Last Update Submit

February 4, 2015

Conditions

Keywords

ObesityNutritionHome Food PreparationPeer MentoringEarly Head StartCookingDiet

Outcome Measures

Primary Outcomes (1)

  • Food Frequency Questionnaire

    The primary outcome will be the change in healthfulness of the diet as measured by food frequency questionnaires for participants through the course of the study. Study staff will meet with each participant and ask them to answer questions about the frequency of their food and beverage consumption over the course of a 12 month period. The results will be analyzed for consumption of specific food-groups (fruits, vegetables, whole grains, dairy, etc.). The primary endpoint is the difference in the healthfulness of the diet between the immediate intervention group and the control group at week 23.

    23 weeks from Baseline

Secondary Outcomes (3)

  • Cooking-related self-efficacy

    23 weeks from Baseline

  • Home food preparation practices

    23 weeks from Baseline

  • Body mass index

    41 weeks from Baseline

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Peer mentoring intervention ('Cooking with Friends')

Behavioral: Peer mentoring intervention ('Cooking with Friends')

Delayed Entry Control

NO INTERVENTION

Interventions

'Cooking with Friends' is a community-located, peer mentoring intervention aimed at improving home food preparation practices in families with young children. The intervention was developed in an iterative, community-based research approach, and will be conducted in partnership with Early Head Start (EHS) at The Children's Hospital of Philadelphia. Cooking with Friends builds on existing monthly cooking classes at EHS that have proven popular with EHS families. Through 5 weekly classes, this intervention will explore topics of how to prepare healthy foods at home. The peer mentoring component is a novel innovation to this intervention. The intervention pairs peer mentors to individual mentees in a community setting, to effect behavioral change among caregivers of young children.

Immediate Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible mentees will be caregivers of 0-3 year old children who are enrolled in Early Head Start at The Children's Hospital of Philadelphia (CHOP EHS) at the time of recruitment.
  • Caregiver enrollment in CHOP EHS requires the following:
  • Children are 0-3 years old (Expectant mothers are also eligible to enroll)
  • The family has an income at or below federal poverty level
  • The family lives in West Philadelphia, within the geographic area served by CHOP EHS.
  • Caregiver is able to give informed consent.
  • The study team, in conjunction with EHS staff, will decide which participants will be invited to be peer mentors, based on attributes including interest, leadership ability, and home food preparation skills.
  • year old children of mentee caregivers enrolled in the study
  • If a mentee caregiver has more than one child currently enrolled in CHOP EHS, then all their eligible children will be enrolled in the study.
  • If there are expectant mothers who are enrolled as mentees, their children will be enrolled in the study upon delivery.

You may not qualify if:

  • Subjects who, in the opinion of the Investigator, may be unable to participate in the study schedules or procedures.
  • Children of peer mentors will not be eligible for this study.

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

Interventions

Cooking

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food HandlingFood IndustryIndustryTechnology, Industry, and Agriculture

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

October 17, 2012

First Posted

October 19, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2013

Study Completion

November 1, 2013

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations