Promoting Healthy Development With the Recipe 4 Success Intervention

Obesity Clinical Trial

Official title:

Promoting Healthy Development With the Recipe 4 Success Intervention: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976089
• Other study ID #: Recipe4Success
• Status: Completed
• Phase: N/A
• Start date: April 5, 2013
• Est. completion date: February 27, 2014

Study information

• Verified date: June 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 27, 2014
• Est. primary completion date: February 27, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 36 Months

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Poverty

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Penn State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percentage of healthy meals consumed	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
Primary	Change in willingness to eat healthy food	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
Primary	Change in healthy body weight	Children's weight and height were collected with standardized scales and tape measures.	Change across three months, from baseline to post-intervention
Primary	Change in children's self-control skills	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
Primary	Change in children's attention	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
Primary	Change in children's compliance	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
Primary	Change in parents' sensitive scaffolding	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
Primary	Change in parents' competent parenting	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
Primary	Change in parents' supportive feeding behaviors	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