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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001857 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mealtime PREP Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Child:
Parent:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela R Caldwell | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
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Participants were recruited between February and June of 2019 using research registry (Pitt + Me) and in the community at WIC (Supplemental Nutrition for Women, Infants and Children) program sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mealtime PREP Intervention | 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 (Promoting Routines of Exploration and Play) intervention to the family. Mealtime PREP Intervention: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mealtime PREP Intervention | 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. Mealtime PREP Intervention: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We only received completed 3-Day Food Diaries from three participants at both baseline and the 3-month follow-up time frame. | Posted | Mean | Standard Deviation | number of unique foods | baseline and 3 months |
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We collected data on adverse events during our intervention period (6 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mealtime PREP Intervention | 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. Mealtime PREP Intervention: 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. |
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This clinical trial is limited by small sample size and difficulty obtaining 3-Day Food Diaries (as participants had to mail these back in a pre-stamped and addressed envelope after completion). No inferences can be made regarding changes observed in the 3-Day food Diary due to this limitation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Angela Caldwell | University of Pittsburgh | 412-383-7231 | arl78@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2020 | Dec 2, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 14, 2020 | Nov 11, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Repeated Measures
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| 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). | baseline and 3 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 3-Day Food Diary | 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 only received 3-Day Food Diaries back from 3 participants at baseline. | Mean | Standard Deviation | number of unique foods |
|
| Parenting Stress Index - Short Form | 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. | Missing data led to inability to score baseline PSIs for 8 participants | Mean | Standard Deviation | units on a scale |
|
| Nutrition Screening Tool for Every Preschooler | 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). | Mean | Standard Deviation | units on a scale |
|
|
|
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| Secondary | 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. | We experienced a significant amount of missing data for the first 8 participants completing this form, which led to an inability to calculate scores for baseline. Research procedures were adjusted, but only had complete data on 9 of 12 remaining participants at 3 months. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
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| Secondary | 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). | 5 participants lost to follow-up | Posted | Mean | Standard Deviation | score on a scale | baseline and 3 months |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |