ObesityNCT03976089
Promoting Healthy Development With the Recipe 4 Success Intervention
A study testing Recipe 4 Success and Treatment as Usual Early Head Start in people with Obesity and Poverty, run by University of Wisconsin, Madison.
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. Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- What is being tested?
- Recipe 4 Success and Treatment as Usual Early Head Start
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2013to 27 Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Promoting Healthy Development With the Recipe 4 Success Intervention: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Recipe 4 Success, Treatment as Usual Early Head Start
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recipe 4 SuccessBehavioural
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 StartBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as Usual Early Head Start |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change across three months, from baseline to post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start5 Apr 2013
- Primary completion27 Feb 2014
- Study completion27 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Sponsor
- Investigators
- Robert Nix, Ph.D., Principal investigator, University of Wisconsin-Madison (previously Pennsylvania State Univeristy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976089
- Sponsor's protocol ID
- Recipe4Success
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33372118
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthy Development With the Recipe 4 Success Intervention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03976089
- Acronym / sponsor ID
- Recipe4Success
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- 5 Apr 2013 (actual)
- Primary completion
- 27 Feb 2014 (actual)
- Study completion
- 27 Feb 2014 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm randomized controlled trial comparing new home visit intervention delivered within Early Head Start to treatment as usual Early Head Start
| Arm | Type | Receives |
|---|---|---|
| Recipe 4 Success intervention | Experimental | Behavioral: Recipe 4 Success10 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. |
| Treatment as usual Early Head Start | Active comparator | Behavioral: Treatment as Usual Early Head StartRegular 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. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recipe 4 SuccessThe 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. | Behavioural | Recipe 4 Success intervention |
| Treatment as Usual Early Head StartTreatment 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. | Behavioural | Treatment as usual Early Head Start |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 33372118Nix 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Nix, Ph.D. principal investigator
University of Wisconsin-Madison (previously Pennsylvania State Univeristy)
Questions about this trial
What is this clinical trial studying?
A study testing Recipe 4 Success and Treatment as Usual Early Head Start in people with Obesity and Poverty, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage of healthy meals consumed (time frame: Change across three months, from baseline to post-intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.