Obesity, ChildhoodProject FEEDNCT03641716
Family Empowerment for Enhanced Development
A study testing Mealtime PREP Intervention in people with Obesity, Childhood and Feeding Behavior, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study evaluates the feasibility and preliminary effects of offering the Mealtime PREP intervention to low-income families with young children. All enrolled families will receive the Mealtime PREP intervention in the home to evaluate the effects on child nutrition. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Feeding Behavior
- What is being tested?
- Mealtime PREP Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2019to 2 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child:
- within age range 2-5 years
- reside in a low-income household (as specified by income within the range to qualify for Special Supplemental Nutrition Program for Women, Infants, and Children.
- Parent:
- >18 years old
- ability to read and speak in English
- willing to participate in 6 home-based intervention sessions
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
This study evaluates the feasibility and preliminary effects of offering the Mealtime PREP intervention to low-income families with young children. All enrolled families will receive the Mealtime PREP intervention in the home to evaluate the effects on child nutrition.
Read the detailed description
Children have not been spared from the obesity epidemic. There is a great need for innovative interventions to help families build healthy habits early in life for obesity prevention. Low-income preschoolers have a disproportionately high rate of childhood obesity, and their families face complex barriers to healthy behavior change. This proposed pilot study will examine the feasibility of delivering the Promoting Routines of Exploration and Play during Mealtime (Mealtime PREP) intervention in a sample of low-income families with young children (ages 2-5). Our parent-mediated intervention is designed to promote healthy dietary variety using routine family meals, positive reinforcement, social modeling, and food exploration and play. By harnessing the behavior change capacity of behavioral activation to alter daily mealtimes incrementally, parents are empowered to overcome barriers to healthy habit formation. Each family will participate in a six-week intervention that is delivered by occupational therapy clinicians in the home environment. Each session will last approximately one hour and include individualized parent-training and a parent-led mealtime with direct feedback from the clinician. We planned to screen up to 100 potential parent and child participants, with a plan to deliver intervention to 20 child participants.
- Conditions
- Obesity, Childhood, Feeding Behavior
- Being tested
- Mealtime PREP Intervention
- Keywords
- early childhood, family, occupational therapy
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mealtime PREP InterventionBehavioural
Also called Promoting Routines of Exploration and Play during Mealtime
Each session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines.
| Study group | Role | What they receive |
|---|---|---|
| Mealtime PREP Intervention | Experimental | Parents of young children will receive 6 weekly sessions, each lasting approximately one-hour, in the home environment. An occupational therapy clinician will deliver the Mealtime PREP intervention to the family. Receives: Behavioral: Mealtime PREP Intervention |
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 3 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. Servings of foods consumed from each food group will be tallied and compared to national daily recommendations. We calculated the number of unique foods consumed at baseline and the 3-month follow-up.
Measured: baseline and 3 months
Secondary outcomes (2)
Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 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. We are reporting the Total parenting stress score.
Measured: Baseline, 3 months
Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 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: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start26 Feb 2019
- Primary completion2 Jan 2020
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity, ChildhoodStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated Measures
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Angela Caldwell, University of Pittsburgh
- Investigators
- Angela R Caldwell, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641716
- Sponsor's protocol ID
- PRO17070504
- Other IDs
- UL1TR001857
- Acronym
- Project FEED
- Status last verified
- Nov 2021
- First submitted
- 20 Aug 2018
- Last updated
- 12 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Empowerment for Enhanced Development
- ClinicalTrials.gov ID
- NCT03641716
- Acronym / sponsor ID
- Project FEED / PRO17070504
- Conditions
- Obesity, Childhood, Feeding Behavior
- Keywords
- early childhood, family, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the feasibility and preliminary effects of offering the Mealtime PREP intervention to low-income families with young children. All enrolled families will receive the Mealtime PREP intervention in the home to evaluate the effects on child nutrition.
Detailed description
Children have not been spared from the obesity epidemic. There is a great need for innovative interventions to help families build healthy habits early in life for obesity prevention. Low-income preschoolers have a disproportionately high rate of childhood obesity, and their families face complex barriers to healthy behavior change. This proposed pilot study will examine the feasibility of delivering the Promoting Routines of Exploration and Play during Mealtime (Mealtime PREP) intervention in a sample of low-income families with young children (ages 2-5). Our parent-mediated intervention is designed to promote healthy dietary variety using routine family meals, positive reinforcement, social modeling, and food exploration and play. By harnessing the behavior change capacity of behavioral activation to alter daily mealtimes incrementally, parents are empowered to overcome barriers to healthy habit formation. Each family will participate in a six-week intervention that is delivered by occupational therapy clinicians in the home environment. Each session will last approximately one hour and include individualized parent-training and a parent-led mealtime with direct feedback from the clinician. We planned to screen up to 100 potential parent and child participants, with a plan to deliver intervention to 20 child participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated Measures
| Arm | Type | Receives |
|---|---|---|
| Mealtime PREP Intervention | Experimental | Behavioral: Mealtime PREP InterventionParents of young children will receive 6 weekly sessions, each lasting approximately one-hour, in the home environment. An occupational therapy clinician will deliver the Mealtime PREP intervention to the family. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- within age range 2-5 years
- reside in a low-income household (as specified by income within the range to qualify for Special Supplemental Nutrition Program for Women, Infants, and Children.
- >18 years old
- ability to read and speak in English
- willing to participate in 6 home-based intervention sessions
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mealtime PREP InterventionAlso: Promoting Routines of Exploration and Play during MealtimeEach session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines. | Behavioural | Mealtime PREP Intervention |
Primary outcome
Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months
Time frame: baseline and 3 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. Servings of foods consumed from each food group will be tallied and compared to national daily recommendations. We calculated the number of unique foods consumed at baseline and the 3-month follow-up.
2 secondary outcomes
Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months
Time frame: Baseline, 3 months
Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months
Time frame: baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 R Caldwell 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 Mealtime PREP Intervention in people with Obesity, Childhood and Feeding Behavior, 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 7 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 12 Nov 2021. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 3 Months (time frame: baseline and 3 months). 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 12 Nov 2021.