NCT03641716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 26, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 8, 2021

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

August 20, 2018

Results QC Date

December 2, 2020

Last Update Submit

November 11, 2021

Conditions

Obesity, ChildhoodFeeding Behavior

Keywords

early childhood, family, occupational therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    Baseline, 3 months

  • Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months

    baseline and 3 months

Study Arms (1)

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.

Behavioral: Mealtime PREP Intervention

Interventions

Mealtime PREP InterventionBEHAVIORAL

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.

Also known as: Promoting Routines of Exploration and Play during Mealtime
Mealtime PREP Intervention

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Pediatric ObesityFeeding Behavior

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Limitations and 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.

Results Point of Contact

Title
Dr. Angela Caldwell
Organization
University of Pittsburgh
arl78@pitt.edu
412-383-7231

Study Officials

  • Angela R Caldwell

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Repeated Measures
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 22, 2018

Study Start

February 26, 2019

Primary Completion

January 2, 2020

Study Completion

January 2, 2020

Last Updated

November 12, 2021

Results First Posted

January 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)