ObesityNCT02458833
Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers
A study testing Home Plate in people with Obesity, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Home Plate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 13 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Able to give informed consent.
- Legal guardian and caregiver of at least one child, age 1-3 years
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Home Plate: A Randomized Controlled Trial of a Community-Engaged Intervention to Improve Home Food Preparation Practices and Health During Early Childhood
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Home Plate
- Keywords
- Obesity, Nutrition, Home Food Preparation, Home Food Environment, Peer Mentoring, Early Head Start, Cooking, Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home PlateBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Behavioral: Home Plate intervention Receives: Behavioral: Home Plate |
| Delayed Entry Control | Experimental | This Arm will receive the Home Plate intervention 3 months after the Intervention Arm completes the intervention. Receives: Behavioral: Home Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 19-30 weeks from baseline
Secondary outcomes (7)
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.
Measured: 19-30 weeks from baseline
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.
Measured: 19-30 weeks from baseline
Household Routines
Adult participants will complete surveys to assess their household routines related to activities such as sleep, physical activity, and screen time.
Measured: 19-30 weeks from baseline
Emotional and Family Health
Adult participants will complete surveys to assess the their emotional health and the health of their families.
Measured: 19-30 weeks from baseline
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.
Measured: 19-30 weeks from baseline
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.
Measured: 19-30 weeks from baseline
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.
Measured: 19-30 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Senbagam Virudachalam, MD, MSHP, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458833
- Sponsor's protocol ID
- 15-011720
- Status last verified
- Apr 2019
- First submitted
- 28 May 2015
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Plate: A Randomized Controlled Trial of a Community-Engaged Intervention to Improve Home Food Preparation Practices and Health During Early Childhood
- ClinicalTrials.gov ID
- NCT02458833
- Acronym / sponsor ID
- 15-011720
- Conditions
- Obesity
- Keywords
- Obesity, Nutrition, Home Food Preparation, Home Food Environment, Peer Mentoring, Early Head Start, Cooking, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Jun 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Home PlateBehavioral: Home Plate intervention |
| Delayed Entry Control | Experimental | Behavioral: Home PlateThis Arm will receive the Home Plate intervention 3 months after the Intervention Arm completes the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- English-speaking
- Able to give informed consent.
- Legal guardian and caregiver of at least one child, age 1-3 years
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home PlateHome 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. | Behavioural | Delayed Entry Control, Intervention |
Primary outcome
Dietary Energy Density (Child Participants)
Time frame: 19-30 weeks from baseline
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.
7 secondary outcomes
Home Food Preparation Practices
Time frame: 19-30 weeks from baseline
Home Food Environment
Time frame: 19-30 weeks from baseline
Household Routines
Time frame: 19-30 weeks from baseline
Emotional and Family Health
Time frame: 19-30 weeks from baseline
Body mass index
Time frame: 19-30 weeks from baseline
Dietary Energy Density (Adult Participants)
Time frame: 19-30 weeks from baseline
Diet Quality
Time frame: 19-30 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senbagam Virudachalam, MD, MSHP principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Plate in people with Obesity, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Energy Density (Child Participants) (time frame: 19-30 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.