ParentingP4PNCT03559907
Partnering for Prevention: Building Healthy Habits in Underserved Communities
A study testing Cooking Matters for Parents and Mealtime PREP in people with Parenting and Child Nutrition Disorders, run by University of Pittsburgh at 1 site in United States.
Trial summary
This pilot study will estimate the unique and additive benefits of two parent-training programs (Cooking Matters for Parents and Promoting Routines of Exploration and Play during Mealtime) offered in undeserved communities. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Child Nutrition Disorders
- What is being tested?
- Cooking Matters for Parents and Mealtime PREP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 5 Nov 2019
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent to a child aged 1-5 years
- Speaks English
- Willing to participate in 6 or 12 weekly group sessions at local Family Support Center
Who cannot join
- Previously completed a Cooking Matters for Parents cooking class
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
This pilot study will estimate the unique and additive benefits of two parent-training programs (Cooking Matters for Parents and Promoting Routines of Exploration and Play during Mealtime) offered in undeserved communities.
Read the detailed description
The overall purpose of this research study is to estimate the nutritional benefits (in terms of intake and variety) of the Mealtime PREP intervention, as compared to, and in combination with nutrition education programming being offered in underserved neighborhoods of the greater Pittsburgh area. This project will examine the effects of Mealtime PREP groups as compared with established nutrition education groups, Cooking Matters for Parents. More importantly, this study will determine if offering these interventions in combination offers greater benefits than each in isolation. There are two specific aims of this pilot trial.
- To examine the effects of a combined program (Cooking Matters + Mealtime PREP) in comparison to offering each of these programs (Cooking Matters vs. Mealtime PREP) in isolation on child nutrition over time.
- To explore the effects of each of these programs (Cooking Matters vs. Mealtime PREP) and the combined program (Cooking Matters + Mealtime PREP) on parental stress and parent/child interaction over time.
The investigators predict that children in all three arms (Cooking Matters, Mealtime PREP, and Cooking Matters + Mealtime PREP) will demonstrate improved nutrition. The investigators also predict that participants who receive the Mealtime PREP intervention will demonstrate better stability of gains over time.
- Conditions
- Parenting, Child Nutrition Disorders
- Being tested
- Cooking Matters for Parents, Mealtime PREP
- Keywords
- prevention, nutrition, early childhood, parent training, underserved
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking Matters for ParentsBehavioural
Cooking Matters for Parents focuses on teaching parents of young children important lessons about self-sufficiency in the kitchen. Participants have the opportunity to practice fundamental lessons including knife skills, reading ingredient labels, cutting up a whole chicken, and making a healthy meal for a family of four on a budget of ten dollars. Each session includes meal preparation, didactic teaching, and sharing the meal as a group. Instructors share their education and experience and discuss how to choose healthy, affordable fruits and vegetables at the grocery store. Each week, adults take home a bag of groceries after each class so they can practice the recipes taught that day.
Mealtime PREPBehavioural
Also called Promoting Routines for Exploration and Play during Mealtime
Parents are trained to deliver each intervention component during mealtimes using a step-wise, behavioral activation approach. The parent-training prong of the Mealtime PREP intervention incorporates four active ingredients of behavioral activation (1. skills training; 2. goal-setting; 3. activity scheduling; and 4. activity monitoring) to help parents build a family meal routine that is enriched with techniques to promote child food acceptance. Each week, parents will take home healthy groceries to practice making healthy snacks and side dishes in the home.
| Study group | Role | What they receive |
|---|---|---|
| Cooking Matters for Parents | Experimental | Trained instructors with a background in nutrition or culinary arts will lead six weekly, two-hour sessions to groups of 10 parent participants at local Family Support Centers. Receives: Behavioral: Cooking Matters for Parents |
| Mealtime PREP | Experimental | Trained group leaders with experience in pediatric occupational therapy will lead six weekly, two-hour, Mealtime PREP sessions to groups of 10 parent participants at local Family Support Centers. Receives: Behavioral: Mealtime PREP |
| Cooking Matters + Mealtime PREP | Experimental | Parents will receive both programs in succession. They will attend Cooking Matters for Parents followed by Mealtime PREP. In total, this will equal 12 weekly, two-hour sessions delivered to groups of 10 parent participants at a local Family Support Center. Receives: Behavioral: Cooking Matters for Parents; Behavioral: Mealtime PREP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline 3-Day Food Diary (dietary variety) at 6 months
The 3-Day Food Diary is the preferred method of dietary assessment (intake and variety of food consumed) because of a balance between validity and burden. Includes all food consumed and approximate servings for 3 days.Frequencies of foods consumed from different food groups and basic nutritional intake related to the numbers of servings of food in each food group consumed will be calculated. Servings in each category will be compared to national daily recommendations.
Measured: 6 months
Secondary outcomes (2)
Change from Baseline Nutrition Screening Tool for Every Preschooler (nutritional risk) at 6 months
17 item, validated screen for young children (1-5 years) that categorizes risk of nutritional problems into 3 categories (score range = 1 (minimum) - 68 (maximum); 1 - 20 = low risk, 21-25 = moderate risk, and 26+ = high risk). Higher scores indicate higher risk for nutritional problems (i.e. lower scores are better).
Measured: 6 months
Change from Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) at 6 months
36 item scale validated in a sample of low-income families with preschoolers to assess parental stress in three domains and overall. Raw scores are converted to percentiles for interpretation using this tool. For the total parenting stress score, and all three domain scores (Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child), higher percentiles are interpreted as higher stress (range =1-99%) with scores >90% indicating clinically significant levels of parenting stress.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start5 Sep 2018
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Model description
- Quasi-Experimental: Three community sites will be randomized to receive on of three prevention interventions: 1. Cooking Matters for Parents 2. Promoting Routines of Exploration and Play during Mealtime (Mealtime PREP) 3. Combined (Cooking Matters + Mealtime PREP)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Principal investigator, Angela Caldwell, University of Pittsburgh
- Investigators
- Angela Caldwell, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559907
- Sponsor's protocol ID
- PRO17080038
- Acronym
- P4P
- Status last verified
- Jan 2020
- First submitted
- 15 May 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caldwell AR, Terhorst L, Krall JS, Thum DW, Uman HR, Dodd JL, Haus EE, Bendixen RM. Partnering for prevention in under-resourced communities: a randomized pilot study. Nutr J. 2022 Nov 25;21(1):72. doi: 10.1186/s12937-022-00824-7.
PubMed 36434698
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnering for Prevention: Building Healthy Habits in Underserved Communities
- ClinicalTrials.gov ID
- NCT03559907
- Acronym / sponsor ID
- P4P / PRO17080038
- Conditions
- Parenting, Child Nutrition Disorders
- Keywords
- prevention, nutrition, early childhood, parent training, underserved
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 18 Jun 2018 (actual)
- 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 pilot study will estimate the unique and additive benefits of two parent-training programs (Cooking Matters for Parents and Promoting Routines of Exploration and Play during Mealtime) offered in undeserved communities.
Detailed description
The overall purpose of this research study is to estimate the nutritional benefits (in terms of intake and variety) of the Mealtime PREP intervention, as compared to, and in combination with nutrition education programming being offered in underserved neighborhoods of the greater Pittsburgh area. This project will examine the effects of Mealtime PREP groups as compared with established nutrition education groups, Cooking Matters for Parents. More importantly, this study will determine if offering these interventions in combination offers greater benefits than each in isolation. There are two specific aims of this pilot trial.
- To examine the effects of a combined program (Cooking Matters + Mealtime PREP) in comparison to offering each of these programs (Cooking Matters vs. Mealtime PREP) in isolation on child nutrition over time.
- To explore the effects of each of these programs (Cooking Matters vs. Mealtime PREP) and the combined program (Cooking Matters + Mealtime PREP) on parental stress and parent/child interaction over time.
The investigators predict that children in all three arms (Cooking Matters, Mealtime PREP, and Cooking Matters + Mealtime PREP) will demonstrate improved nutrition. The investigators also predict that participants who receive the Mealtime PREP intervention will demonstrate better stability of gains over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Quasi-Experimental: Three community sites will be randomized to receive on of three prevention interventions: 1. Cooking Matters for Parents 2. Promoting Routines of Exploration and Play during Mealtime (Mealtime PREP) 3. Combined (Cooking Matters + Mealtime PREP)
| Arm | Type | Receives |
|---|---|---|
| Cooking Matters for Parents | Experimental | Behavioral: Cooking Matters for ParentsTrained instructors with a background in nutrition or culinary arts will lead six weekly, two-hour sessions to groups of 10 parent participants at local Family Support Centers. |
| Mealtime PREP | Experimental | Behavioral: Mealtime PREPTrained group leaders with experience in pediatric occupational therapy will lead six weekly, two-hour, Mealtime PREP sessions to groups of 10 parent participants at local Family Support Centers. |
| Cooking Matters + Mealtime PREP | Experimental | Behavioral: Cooking Matters for Parents, Behavioral: Mealtime PREPParents will receive both programs in succession. They will attend Cooking Matters for Parents followed by Mealtime PREP. In total, this will equal 12 weekly, two-hour sessions delivered to groups of 10 parent participants at a local Family Support Center. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parent to a child aged 1-5 years
- Speaks English
- Willing to participate in 6 or 12 weekly group sessions at local Family Support Center
Key exclusion criteria (1 listed)
- Previously completed a Cooking Matters for Parents cooking class
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 |
|---|---|---|
| Cooking Matters for ParentsCooking Matters for Parents focuses on teaching parents of young children important lessons about self-sufficiency in the kitchen. Participants have the opportunity to practice fundamental lessons including knife skills, reading ingredient labels, cutting up a whole chicken, and making a healthy meal for a family of four on a budget of ten dollars. Each session includes meal preparation, didactic teaching, and sharing the meal as a group. Instructors share their education and experience and discuss how to choose healthy, affordable fruits and vegetables at the grocery store. Each week, adults take home a bag of groceries after each class so they can practice the recipes taught that day. | Behavioural | Cooking Matters + Mealtime PREP, Cooking Matters for Parents |
| Mealtime PREPAlso: Promoting Routines for Exploration and Play during MealtimeParents are trained to deliver each intervention component during mealtimes using a step-wise, behavioral activation approach. The parent-training prong of the Mealtime PREP intervention incorporates four active ingredients of behavioral activation (1. skills training; 2. goal-setting; 3. activity scheduling; and 4. activity monitoring) to help parents build a family meal routine that is enriched with techniques to promote child food acceptance. Each week, parents will take home healthy groceries to practice making healthy snacks and side dishes in the home. | Behavioural | Cooking Matters + Mealtime PREP, Mealtime PREP |
Primary outcome
Change from Baseline 3-Day Food Diary (dietary variety) at 6 months
Time frame: 6 months
The 3-Day Food Diary is the preferred method of dietary assessment (intake and variety of food consumed) because of a balance between validity and burden. Includes all food consumed and approximate servings for 3 days.Frequencies of foods consumed from different food groups and basic nutritional intake related to the numbers of servings of food in each food group consumed will be calculated. Servings in each category will be compared to national daily recommendations.
2 secondary outcomes
Change from Baseline Nutrition Screening Tool for Every Preschooler (nutritional risk) at 6 months
Time frame: 6 months
Change from Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) at 6 months
Time frame: 6 months
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 6 Jan 2020.
- Derived from this study: PubMed 36434698Caldwell AR, Terhorst L, Krall JS, Thum DW, Uman HR, Dodd JL, Haus EE, Bendixen RM. Partnering for prevention in under-resourced communities: a randomized pilot study. Nutr J. 2022 Nov 25;21(1):72. doi: 10.1186/s12937-022-00824-7.
- Individual participant dataSharing planned: No
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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.
Angela Caldwell, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking Matters for Parents and Mealtime PREP in people with Parenting and Child Nutrition Disorders, run by University of Pittsburgh 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 3 inclusion and 1 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 6 Jan 2020. 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?
Change from Baseline 3-Day Food Diary (dietary variety) at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559907, which also lists 1 linked publication.
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 6 Jan 2020.