Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start

The purpose of this study is to test the effectiveness of a new curriculum on toddlers' self-regulation skills and healthy eating habits. The curriculum is being delivered as part of Early Head Start home visits and compared to the effectiveness of usual practice Early Head Start home visits.

Study Overview

• Status: Completed
• Conditions: Poverty
• Intervention / Treatment: Behavioral: Recipe 4 Success; Behavioral: Usual practice Early Head Start

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children must be receiving Early Head Start home visits and be at least 2 years old at the beginning of the study.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recipe 4 Success; For 12 weeks, home visitors will stop delivering the usual practice Early Head Start home visits and deliver the Recipe 4 Success curriculum instead. At the end of 12 weeks, home visitors will resume usual practice Early Head Start home visits.	Behavioral: Recipe 4 Success; Home visitors teach parents about children's self-regulation skills and healthy eating habits. The home visitors then teach parents how to sensitively scaffold the development of their toddlers' self-regulation skills in the context of cooking and snack preparation lessons. Prior research shows that self-regulation skills in early childhood predict long-term health indicators, such as BMI. Prior research also shows that children who are involved in the preparation of healthier foods are more likely to eat them.
Active Comparator: Usual practice Early Head Start; Home visitors will continue to deliver usual practice Early Head Start home visits that follow a standard curriculum and are tailored on an ongoing basis to meet individual family needs.	Behavioral: Usual practice Early Head Start; Home visitors will continue to deliver usual practice Early Head Start home visits that follow a standard curriculum and are tailored on an ongoing basis to meet individual family needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in children's healthy eating habits: Body mass index	Healthy eating habits will be assessed through change in body mass index	Baseline / up to 18 months
Change in children's healthy eating habits: Food diaries	Healthy eating habits will be assessed through change in consumption of fruits/vegetables and junk food, as assessed with 24-hour food diaries	Baseline / up to 18 months
Change in children's healthy eating habits: Parent reports	Healthy eating habits will be assessed through parent survey of pickiness, etc.; mean scores reported from 5-point Likert scales with higher scores indicating healthier eating habits	Baseline / up to 18 months
Change in children's self-control skills: Direct testing	Children's self-control skills will be assessed through direct testing (e.g., snack delay task)	Baseline / up to 18 months
Change in children's self-control skills: Video interactions	Children's self-control skills will be assessed through parent-child interactions, rated on Likert scale from video recordings; mean score reported between 1 = almost never and 5 = almost always	Baseline / up to 18 months
Change in children's self-control skills: Parent ratings	Children's self-control skills will be assessed through parent ratings on standardized behavior checklists; mean scores reported from 3- or 5-point Likert scales with higher scores indicating greater self-control	Baseline / up to 18 months
Change in parents' sensitive/responsiveness: Video interactions	Parents' sensitive/responsiveness will be assessed through parent-child interactions, rated on Likert scale from video recordings; mean score reported between 1 = almost never and 5 = almost always	Baseline / up to 18 months
Change in parents' sensitive/responsiveness: Parent ratings	Parents' sensitive/responsiveness will be assessed through parent ratings on standardized surveys; mean scores reported from 5-point Likert scales with higher scores indicating greater sensitive/responsiveness	Baseline / up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in children's sleep habits: Parent reports	Sleep habits will be assessed through parent survey; mean scores reported from 5-point Likert scales with higher scores indicating better sleep habits	Baseline / up to 18 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Penn State University
• Investigators: Principal Investigator: Robert Nix, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2016
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: February 11, 2017
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016-0465; A271000 (Other Identifier: UW Madison); SOHE/SOHE/SOHE*ADMIN (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No