ObesityNCT01710423
Peer-mentored Cooking Classes for Parents of Toddlers: Do Families Cook More and Eat Healthier After the Intervention?
A study testing Peer mentoring intervention ('Cooking with Friends') 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-located, peer mentored intervention to improve home food preparation practices in families with young children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- What is being tested?
- Peer mentoring intervention ('Cooking with Friends')
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Nov 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Caregivers and children not meeting the inclusion criteria above.
- 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.
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: Improving Home Food Preparation Practices Among Families With Young Children: A Peer Mentoring Intervention
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.
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. Preparing food at home entails a sequence of steps from obtaining food, to planning and cooking or preparing meals, to finally serving and eating the meal. Many strategies to curb obesity in children focus on eliminating processed and fast food from the diet, as well as improving access to fresh produce and other healthy ingredients. A collective ability to regularly and reliably prepare healthy food at home is implicit in these and other prevention strategies. Little research, however, has grappled with the phenomenon that there has been a generational loss of home food preparation ability over the past few decades. What is urgently needed is to design effective, enticing, and scalable interventions to improve home food preparation practices across diverse groups.
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. The investigators will partner with Children's Hospital of Philadelphia Early Head Start, a community-based organization serving families with children ages 0 to 3 years in West Philadelphia, aiming specifically to:
- Use the principles of Community Based Participatory Research (CBPR) to design, evaluate and disseminate a peer mentored intervention aimed at improving home food preparation practices among families with young children.
- Conduct a randomized controlled trial with a delayed entry control group to test the effect of the intervention on three outcomes: home food preparation practices, healthfulness of the diet, and cooking-related self-efficacy.
The investigators hypothesize that families participating in this intervention will demonstrate improvement in parental self-efficacy related to cooking, home food preparation practices, and the healthfulness of parents' and toddlers' diets post-intervention, compared to families who do not participate in the intervention.
- Conditions
- Obesity
- Being tested
- Peer mentoring intervention ('Cooking with Friends')
- Keywords
- Obesity, Nutrition, Home Food Preparation, 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.
Peer mentoring intervention ('Cooking with Friends')Behavioural
'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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Peer mentoring intervention ('Cooking with Friends') Receives: Behavioral: Peer mentoring intervention ('Cooking with Friends') |
| Delayed Entry Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 23 weeks from Baseline
Secondary outcomes (3)
Cooking-related self-efficacy
Self-efficacy related to cooking will be measured using a 25-item instrument. We will assess to assess the difference between the immediate intervention group and the control group at week 23.
Measured: 23 weeks from Baseline
Home food preparation practices
Home food preparation practices will be measured using questions from the National Health and Nutrition Examination Survey. We will measure the difference in home food preparation practices between the immediate intervention group and the control group at week 23.
Measured: 23 weeks from Baseline
Body mass index
We will measure the change in parent and child body mass index before and after the intervention.
Measured: 41 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 posted19 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionNov 2013
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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Senbagam Virudachalam, MD, MSHP, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710423
- Sponsor's protocol ID
- 12-009579
- Status last verified
- Feb 2015
- First submitted
- 17 Oct 2012
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Home Food Preparation Practices Among Families With Young Children: A Peer Mentoring Intervention
- ClinicalTrials.gov ID
- NCT01710423
- Acronym / sponsor ID
- 12-009579
- Conditions
- Obesity
- Keywords
- Obesity, Nutrition, Home Food Preparation, Peer Mentoring, Early Head Start, Cooking, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Oct 2012 (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-located, 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. Preparing food at home entails a sequence of steps from obtaining food, to planning and cooking or preparing meals, to finally serving and eating the meal. Many strategies to curb obesity in children focus on eliminating processed and fast food from the diet, as well as improving access to fresh produce and other healthy ingredients. A collective ability to regularly and reliably prepare healthy food at home is implicit in these and other prevention strategies. Little research, however, has grappled with the phenomenon that there has been a generational loss of home food preparation ability over the past few decades. What is urgently needed is to design effective, enticing, and scalable interventions to improve home food preparation practices across diverse groups.
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. The investigators will partner with Children's Hospital of Philadelphia Early Head Start, a community-based organization serving families with children ages 0 to 3 years in West Philadelphia, aiming specifically to:
- Use the principles of Community Based Participatory Research (CBPR) to design, evaluate and disseminate a peer mentored intervention aimed at improving home food preparation practices among families with young children.
- Conduct a randomized controlled trial with a delayed entry control group to test the effect of the intervention on three outcomes: home food preparation practices, healthfulness of the diet, and cooking-related self-efficacy.
The investigators hypothesize that families participating in this intervention will demonstrate improvement in parental self-efficacy related to cooking, home food preparation practices, and the healthfulness of parents' and toddlers' diets post-intervention, compared to families who do not participate in the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Peer mentoring intervention ('Cooking with Friends')Peer mentoring intervention ('Cooking with Friends') |
| Delayed Entry Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Caregivers and children not meeting the inclusion criteria above.
- 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.
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 |
|---|---|---|
| Peer mentoring intervention ('Cooking with Friends')'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. | Behavioural | Immediate Intervention |
Primary outcome
Food Frequency Questionnaire
Time frame: 23 weeks from Baseline
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.
3 secondary outcomes
Cooking-related self-efficacy
Time frame: 23 weeks from Baseline
Home food preparation practices
Time frame: 23 weeks from Baseline
Body mass index
Time frame: 41 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 5 Feb 2015.
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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 Peer mentoring intervention ('Cooking with Friends') 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 0 inclusion and 3 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 5 Feb 2015. 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?
Food Frequency Questionnaire (time frame: 23 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 5 Feb 2015.