Clinical trial NCT03976089: Promoting Healthy Development With the Recipe 4 Success Intervention
Official title: Promoting Healthy Development With the Recipe 4 Success Intervention: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Poverty
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2019-06-05
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Change in percentage of healthy meals consumed
timeFrame: Change across three months, from baseline to post-intervention
measure: Change in willingness to eat healthy food
timeFrame: Change across three months, from baseline to post-intervention
measure: Change in healthy body weight
timeFrame: Change across three months, from baseline to post-intervention
measure: Change in children's self-control skills
timeFrame: Change across three months, from baseline to post-intervention
measure: Change in children's attention
timeFrame: Change across three months, from baseline to post-intervention
measure: Change in children's compliance
timeFrame: Change across three months, from baseline to post-intervention
measure: Change in parents' sensitive scaffolding
timeFrame: Change across three months, from baseline to post-intervention
measure: Change in parents' competent parenting
timeFrame: Change across three months, from baseline to post-intervention
measure: Change in parents' supportive feeding behaviors
timeFrame: Change across three months, from baseline to post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin-Madison (previously Pennsylvania State Univeristy)
name: Robert Nix, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nix RL, Francis LA, Feinberg ME, Gill S, Jones DE, Hostetler ML, Stifter CA. Improving Toddlers' Healthy Eating Habits and Self-regulation: A Randomized Controlled Trial. Pediatrics. 2021 Jan;147(1):e20193326. doi: 10.1542/peds.2019-3326.