Trial Outcomes & Findings for Family Empowerment for Enhanced Development (NCT NCT03641716)

Last Updated: 2021-11-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

baseline and 3 months

Results posted on

2021-11-12

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We only received 3-Day Food Diaries back from 3 participants at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mealtime PREP Intervention n=20 Participants 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.
Age, Categorical <=18 years	20 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants
Age, Continuous	43.76 months STANDARD_DEVIATION 12.49 • n=20 Participants
Sex: Female, Male Female	9 Participants n=20 Participants
Sex: Female, Male Male	11 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	9 Participants n=20 Participants
Race (NIH/OMB) White	5 Participants n=20 Participants
Race (NIH/OMB) More than one race	4 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants
3-Day Food Diary	19 number of unique foods STANDARD_DEVIATION 5 • n=3 Participants • We only received 3-Day Food Diaries back from 3 participants at baseline.
Parenting Stress Index - Short Form	75.67 units on a scale STANDARD_DEVIATION 30.16 • n=12 Participants • Missing data led to inability to score baseline PSIs for 8 participants
Nutrition Screening Tool for Every Preschooler	22.90 units on a scale STANDARD_DEVIATION 8.94 • n=20 Participants

PRIMARY outcome

Timeframe: baseline and 3 months

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

Outcome measures

Outcome measures
Measure	Mealtime PREP Intervention n=3 Participants 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.
Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months	3.66 number of unique foods Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mealtime PREP Intervention n=9 Participants 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.
Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months	0.22 score on a scale Standard Deviation 25.04

SECONDARY outcome

Timeframe: baseline and 3 months

Population: 5 participants lost to follow-up

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).

Outcome measures

Outcome measures
Measure	Mealtime PREP Intervention n=15 Participants 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.
Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months	-2.80 score on a scale Standard Deviation 5.43

Adverse Events

Mealtime PREP Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Angela Caldwell

University of Pittsburgh

Phone: 412-383-7231

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place