Promoting Healthy Development With the Recipe 4 Success Intervention
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| ClinicalTrials.gov Identifier: NCT03976089 |
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Recruitment Status :
Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
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Sponsor:
University of Wisconsin, Madison
Collaborator:
Penn State University
Information provided by (Responsible Party):
University of Wisconsin, Madison
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Brief Summary:
10-session home visit intervention conducted within Early Head Start and designed to reduce low-income toddler's obesity risk and improve their self-regulation skills and parents' sensitivity.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity Poverty | Behavioral: Recipe 4 Success Behavioral: Treatment as Usual Early Head Start | Not Applicable |
Recipe 4 Success, the product of a university-community engagement collaboration, uses 10 tightly sequenced, structured, and scripted food preparation lessons, delivered as part of Early Head Start home visits, to help low-income parents learn to sensitively scaffold their toddler's self-regulation skills and establish more healthy eating habits. The intervention relies on an active coaching therapeutic approach to deliver content. Recipe 4 Success is focused on parents because their feeding practices influence children's diet, and interventions to prevent childhood obesity are most likely to have long-term effects when they emphasize positive parenting practices. Parents' sensitivity and constructive scaffolding behaviors are related to children's self-regulation skills, which are robust predictors of healthy eating habits and body mass index (BMI). For example, children who have difficulty with self-regulation by age 3 have a higher BMI through age 12. Importantly, these relations may be causal: Adults who are taught self-regulation skills appear more successful in maintaining healthy eating habits over time. As a preventive intervention, Recipe 4 Success is implemented when children are 2, the point at which deliberate self-regulation skills are starting to emerge and develop rapidly and taste preferences are being formed. Recipe 4 Success is designed for families living in poverty because parents are less likely to provide sensitive scaffolding and children are less likely to display well-developed self-regulation skills and healthy eating habits under conditions of economic adversity. Finally, Recipe 4 Success was created to be integrated into Early Head Start to expedite wide-spread dissemination and easy sustainability and to enhance the efficacy of this nation-wide home visit program. If successful, this will be one of the first preventive interventions to improve either toddler's self-regulation skills or their healthy eating habits and BMI.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 73 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 2-arm randomized controlled trial comparing new home visit intervention delivered within Early Head Start to treatment as usual Early Head Start |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | Families were randomly assigned to condition and either started new Recipe 4 Success home visits for 10 weeks or continued the standard Early Head Start home visits they had been receiving. Interviewers collecting all outcome data were blind to study condition. |
| Primary Purpose: | Prevention |
| Official Title: | Promoting Healthy Development With the Recipe 4 Success Intervention: A Randomized Controlled Trial |
| Actual Study Start Date : | April 5, 2013 |
| Actual Primary Completion Date : | February 27, 2014 |
| Actual Study Completion Date : | February 27, 2014 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: Recipe 4 Success
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. |
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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.
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Behavioral: Treatment as Usual Early Head Start
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. |
Primary Outcome Measures :
- 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 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 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 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 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 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 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 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 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.
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| Ages Eligible for Study: | 18 Months to 36 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
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): NCT03976089
Sponsors and Collaborators
University of Wisconsin, Madison
Penn State University
Investigators
| Principal Investigator: | Robert Nix, Ph.D. | University of Wisconsin-Madison (previously Pennsylvania State Univeristy) |
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT03976089 |
| Other Study ID Numbers: |
Recipe4Success |
| First Posted: | June 5, 2019 Key Record Dates |
| Last Update Posted: | June 5, 2019 |
| Last Verified: | June 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |