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

Poverty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958214
• Other study ID #: 2016-0465
• Secondary ID: A271000SOHE/SOHE
• Status: Completed
• Phase: N/A
• Start date: November 8, 2016
• Est. completion date: January 20, 2020

Study information

• Verified date: February 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 3 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Poverty

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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