NCT03958214

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2017

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

3.2 years

First QC Date

February 11, 2017

Last Update Submit

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

EXPERIMENTAL

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

Usual practice Early Head Start

ACTIVE COMPARATOR

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

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.

Recipe 4 Success

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.

Usual practice Early Head Start

Eligibility Criteria

Age2 Years - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

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.

Study Officials

  • Robert Nix, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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

Locations