- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03976089
Promoting Healthy Development With the Recipe 4 Success Intervention
Promoting Healthy Development With the Recipe 4 Success Intervention: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Family lives in York, Allentown, Williamsport/Lock Haven Pennsylvania
- Family enrolled in Early Head Start home visit program
- Target child 18-36 months old at beginning of study
Exclusion Criteria:
- Family considered "in crisis" by home visitor (i.e., not able to focus on new intervention lessons because of child custody, family violence, mental health, or housing issues that currently demand parents' full attention)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Recipe 4 Success intervention
10 lessons delivered across 10 successive weeks within Early Head Start infrastructure by families' regular Early Head Start home visitors.
Lessons involved active coaching in which parents and children prepared healthy snacks or meals.
Lessons also included information on children's self-regulation skills and healthy eating habits.
|
The Recipe 4 Success intervention consisted of 10 weekly lessons in which parents and toddlers prepared simple snacks or meals. All Recipe 4 Success lessons started and ended with some evidence-based information for the parents about children's self-regulation skills or healthy eating habits. Most of each lesson in Recipe 4 Success was devoted to the snack or meal preparation activities. Each week, home visitors coached the parents as they worked with their toddlers to make increasingly challenging snacks and meals. During these activities, home visitors pointed out opportunities for parents to practice sensitive scaffolding strategies. At the same time, these meal and snack preparation activities allowed children to practice multiple age-appropriate self-regulation skills. |
Active Comparator: Treatment as usual Early Head Start
Regular Early Head Start home visitors continued to implement evidence-informed developmentally appropriate curriculum designed to promote children's physical health, cognitive skills, and social-emotional functioning as well as parents' capacities to support their children's development.
|
Treatment as Usual Early Head Start consisted of an evidence-based curriculum (usually Parents as Teachers) in which home visitors and parents worked with children on activities to support their physical, cognitive, and social-emotional development.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in percentage of healthy meals consumed
Time Frame: Change across three months, from baseline to post-intervention
|
Daily food diaries were collected across three 24-hour periods.
The percentage of meals that included at least one fruit and/or vegetable, at least one source of protein, and that did not include any sweets or junk food was calculated.
|
Change across three months, from baseline to post-intervention
|
Change in willingness to eat healthy food
Time Frame: Change across three months, from baseline to post-intervention
|
As part of the study assessment battery, parents were given novel healthy foods, such as dried seaweed, and asked to see if their children would like to eat them.
The percentage of novel foods that children at least tasted was calculated.
|
Change across three months, from baseline to post-intervention
|
Change in healthy body weight
Time Frame: Change across three months, from baseline to post-intervention
|
Children's weight and height were collected with standardized scales and tape measures.
|
Change across three months, from baseline to post-intervention
|
Change in children's self-control skills
Time Frame: Change across three months, from baseline to post-intervention
|
Children completed a snack delay task in which an M&M was placed on a plate but the interviewer asked the children to wait 5-60 seconds before eating the M&M.
The percentage of the four trials in which the child was able to wait the entire time requested before eating the M&M was calculated.
|
Change across three months, from baseline to post-intervention
|
Change in children's attention
Time Frame: Change across three months, from baseline to post-intervention
|
Children and their parents participated in three interaction tasks.
Raters blind to study condition rated the ability of the children to concentrate and stay focused on what they were doing with their parents on a Likert scale with 1=almost never to 5 = almost always.
|
Change across three months, from baseline to post-intervention
|
Change in children's compliance
Time Frame: Change across three months, from baseline to post-intervention
|
Parents' completed the 8-item compliance subscale of the well-validated Infant and Toddler Social and Emotional Assessment.
Each item was rated on a Likert scale with 1 = not true to 3 = very true.
|
Change across three months, from baseline to post-intervention
|
Change in parents' sensitive scaffolding
Time Frame: Change across three months, from baseline to post-intervention
|
Children and their parents participated in three interaction tasks.
Raters blind to study condition rated the ability of the parents to sensitively scaffold their children's learning of a new task on a Likert scale with 1=almost never to 5 = almost always.
|
Change across three months, from baseline to post-intervention
|
Change in parents' competent parenting
Time Frame: Change across three months, from baseline to post-intervention
|
Children and their parents participated in three interaction tasks.
Raters blind to study condition rated the overall competence of the parents on four items such as "The parent seemed very effective in interacting with the child" on a Likert scale with 1=almost never to 5 = almost always.
|
Change across three months, from baseline to post-intervention
|
Change in parents' supportive feeding behaviors
Time Frame: Change across three months, from baseline to post-intervention
|
As part of the study assessment battery, parents were given novel healthy foods, such as dried seaweed, and asked to see if their children would like to eat them.
Interviewers blind to study condition rated whether or not parents engaged in four behaviors for each specific snack, such as "Parent modeled enjoyment of health food by tasting it her/himself."
The percentage of times parents demonstrated such supportive feeding behaviors was calculated.
|
Change across three months, from baseline to post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Nix, Ph.D., University of Wisconsin-Madison (previously Pennsylvania State Univeristy)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Recipe4Success
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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