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

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ClinicalTrials.gov Identifier: NCT03958214
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Poverty Behavioral: Recipe 4 Success Behavioral: Usual practice Early Head Start Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Families are blocked within home visitor caseload and randomly assigned to receive the new curriculum or usual practice Early Head Start home visits for 12 weeks.
Masking: Single (Outcomes Assessor)
Masking Description: All interviews are conducted by research assistants who are blind to study condition.
Primary Purpose: Prevention
Official Title: Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start
Actual Study Start Date : November 8, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   2 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958214


Contacts
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Contact: Robert Nix, PhD 608-890-3283 robert.nix@wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53706
Contact: Robert Nix, PhD    608-890-3283    robert.nix@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Penn State University
Investigators
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Principal Investigator: Robert Nix, PhD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03958214     History of Changes
Other Study ID Numbers: 2016-0465
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No