Project FEED: Family Empowerment for Enhanced Development

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT03641716
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Childhood; Feeding Behavior	Behavioral: Mealtime PREP Intervention	N/A

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

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Repeated MeasuresRepeated Measures
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Family Empowerment for Enhanced Development
• Actual Study Start Date: Feb 26, 2019
• Actual Primary Completion Date: Jan 2, 2020
• Actual Study Completion Date: Jan 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Promoting Routines of Exploration and Play during Mealtime

Outcome Measures

Primary Outcome Measures

1. Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months [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.

Secondary Outcome Measures

1. Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months [Baseline, 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.

2. Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months [baseline and 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15260

Sponsors and Collaborators

• University of Pittsburgh
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Angela R Caldwell, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 14, 2020
• Informed Consent Form - May 14, 2020

More Information

Publications

None provided.

• Responsible Party: Angela Caldwell, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03641716
• Other Study ID Numbers: PRO17070504; UL1TR001857
• First Posted: Aug 22, 2018
• Last Update Posted: Nov 12, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Angela Caldwell, Assistant Professor, University of Pittsburgh: early childhood, family, occupational therapy
• Additional relevant MeSH terms: Pediatric Obesity

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Mealtime PREP Intervention
Arm/Group Description	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.
Period Title: Overall Study
STARTED	20
COMPLETED	15
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Mealtime PREP Intervention
Arm/Group Description	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.
Overall Participants	20
Age (Count of Participants)
<=18 years	20 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	43.76 (12.49)
Sex: Female, Male (Count of Participants)
Female	9 45%
Male	11 55%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5%
Not Hispanic or Latino	19 95%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	9 45%
White	5 25%
More than one race	4 20%
Unknown or Not Reported	1 5%
Region of Enrollment (participants) [Number]
United States	20 100%
3-Day Food Diary (number of unique foods) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of unique foods]	19 (5)
Parenting Stress Index - Short Form (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	75.67 (30.16)
Nutrition Screening Tool for Every Preschooler (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	22.90 (8.94)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months
Description	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.
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

We only received completed 3-Day Food Diaries from three participants at both baseline and the 3-month follow-up time frame.

Arm/Group Title	Mealtime PREP Intervention
Arm/Group Description	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.
Measure Participants	3
Mean (Standard Deviation) [number of unique foods]	3.66 (2.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mealtime PREP Intervention
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.67
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 2.08
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months
Description	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.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Mealtime PREP Intervention
Arm/Group Description	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.
Measure Participants	9
Mean (Standard Deviation) [score on a scale]	0.22 (25.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mealtime PREP Intervention
	Comments	Due to limited size of sub-sample, we calculated a Cohen's d effect size for raw total score on the PSI from baseline to the 3-month follow-up, with a 95% confidence interval.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Effect Size - Cohen's d
	Estimated Value	-.01
	Confidence Interval	(2-Sided) 95%; -.66 to .65
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months
Description	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).
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

5 participants lost to follow-up

Arm/Group Title	Mealtime PREP Intervention
Arm/Group Description	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.
Measure Participants	15
Mean (Standard Deviation) [score on a scale]	-2.80 (5.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mealtime PREP Intervention
	Comments	After examining the data to ensure it met the statistical assumptions (e.g. normality, no outliers), we ran a paired-sample pre-post t-test to examine the difference in scores from baseline to 3 months on the NutriSTEP (Screening Tool for Every Preschooler) assessment.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.01
	Comments	a prior threshold for statistical significance set at p<.05
	Method	t-test, 2 sided
	Comments	We ran a paired samples t-test with pre/post intervention data (from baseline and 3-month assessments).

Adverse Events

Time Frame	We collected data on adverse events during our intervention period (6 weeks)
Arm/Group Title	Mealtime PREP Intervention
Arm/Group Description	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.
All Cause Mortality
	Mealtime PREP Intervention
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Mealtime PREP Intervention
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Mealtime PREP Intervention
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.