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Completed

NCT Number: NCT03958214

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.

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Key information

Conditions

Poverty

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Recipe 4 Success

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in children's healthy eating habits: Body mass index

    Time frame: Baseline / up to 18 months

    Healthy eating habits will be assessed through change in body mass index

  2. Change in children's healthy eating habits: Food diaries

    Time frame: Baseline / up to 18 months

    Healthy eating habits will be assessed through change in consumption of fruits/vegetables and junk food, as assessed with 24-hour food diaries

  3. Change in children's healthy eating habits: Parent reports

    Time frame: Baseline / up to 18 months

    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

  4. Change in children's self-control skills: Direct testing

    Time frame: Baseline / up to 18 months

    Children's self-control skills will be assessed through direct testing (e.g., snack delay task)

  5. Change in children's self-control skills: Video interactions

    Time frame: Baseline / up to 18 months

    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

  6. Change in children's self-control skills: Parent ratings

    Time frame: Baseline / up to 18 months

    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

  7. Change in parents' sensitive/responsiveness: Video interactions

    Time frame: Baseline / up to 18 months

    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

  8. Change in parents' sensitive/responsiveness: Parent ratings

    Time frame: Baseline / up to 18 months

    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

Secondary outcomes

  1. Change in children's sleep habits: Parent reports

    Time frame: Baseline / up to 18 months

    Sleep habits will be assessed through parent survey; mean scores reported from 5-point Likert scales with higher scores indicating better sleep habits

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Penn State University

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 21, 2019
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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