Clinical trial NCT02458833: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Nutrition
Home Food Preparation
Home Food Environment
Peer Mentoring
Early Head Start
Cooking
Diet
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2015-06-01
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

1. 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.
2. Test the intervention's effect on family health.

   Hypothesis 2: The intervention group will report improved parenting skills and more hopeful patterns of thinking.
3. 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.

Eligibility criteria: Inclusion Criteria: mentees

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

Inclusion Criteria: children

1. 1-3 year old children of mentee primary caregivers enrolled in the study
2. 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

1. 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,
2. 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

1. Caregivers and children not meeting the inclusion criteria above.
2. Caregivers who are pregnant at the time of enrollment.
3. 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.)
4. Subjects who, in the opinion of the Investigator, may be unable to participate in the study schedules or procedures.

Primary outcomes:
measure: Dietary Energy Density (Child Participants)
timeFrame: 19-30 weeks from baseline
Secondary outcomes:
measure: Home Food Preparation Practices
timeFrame: 19-30 weeks from baseline
measure: Home Food Environment
timeFrame: 19-30 weeks from baseline
measure: Household Routines
timeFrame: 19-30 weeks from baseline
measure: Emotional and Family Health
timeFrame: 19-30 weeks from baseline
measure: Body mass index
timeFrame: 19-30 weeks from baseline
measure: Dietary Energy Density (Adult Participants)
timeFrame: 19-30 weeks from baseline
measure: Diet Quality
timeFrame: 19-30 weeks from baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Senbagam Virudachalam, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: