Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start
3 other identifiers
interventional
244
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
November 8, 2016
CompletedFirst Submitted
Initial submission to the registry
February 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2020
CompletedFebruary 27, 2020
February 1, 2020
3.2 years
February 11, 2017
February 25, 2020
Conditions
Outcome Measures
Primary Outcomes (8)
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 Outcomes (1)
Change in children's sleep habits: Parent reports
Baseline / up to 18 months
Study Arms (2)
Recipe 4 Success
EXPERIMENTALFor 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.
Usual practice Early Head Start
ACTIVE COMPARATORHome 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Children must be receiving Early Head Start home visits and be at least 2 years old at the beginning of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Penn State Universitycollaborator
Study Sites (1)
University of Wisconsin-Madison
Madison, Wisconsin, 53706, United States
Related Publications (1)
Engbretson AM, Nix RL, Park YR, Gill S, Hostetler ML. Elaboration of parents' schemas of their children: Unique relations to sensitivity and learning support among families living in poverty. J Fam Psychol. 2023 Apr;37(3):318-323. doi: 10.1037/fam0001048. Epub 2023 Jan 2.
PMID: 36595449DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Nix, PhD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- All interviews are conducted by research assistants who are blind to study condition.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2017
First Posted
May 21, 2019
Study Start
November 8, 2016
Primary Completion
January 20, 2020
Study Completion
January 20, 2020
Last Updated
February 27, 2020
Record last verified: 2020-02