Promoting Healthy Development With the Recipe 4 Success Intervention

NCT03976089 | Completed

• 1 other identifier: Recipe4Success
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Poverty

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Recipe 4 Success intervention

EXPERIMENTAL

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.

Behavioral: Recipe 4 Success

Treatment as usual Early Head Start

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual Early Head Start

Interventions

Recipe 4 Success BEHAVIORAL

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.

Recipe 4 Success intervention

Treatment as Usual Early Head Start BEHAVIORAL

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.

Treatment as usual Early Head Start

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Penn State University: collaborator

Related Publications (1)

• 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.

  PMID: 33372118 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Nix, Ph.D.

  University of Wisconsin-Madison (previously Pennsylvania State Univeristy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2-arm randomized controlled trial comparing new home visit intervention delivered within Early Head Start to treatment as usual Early Head Start

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: April 5, 2013
• Primary Completion: February 27, 2014
• Study Completion: February 27, 2014
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share