PovertyNCT03958214
Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start
A study testing Recipe 4 Success and Usual practice Early Head Start in people with Poverty, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a new curriculum on toddlers' self-regulation skills and healthy eating habits. The curriculum is being delivered as part of Early Head Start home visits and compared to the effectiveness of usual practice Early Head Start home visits. Read more about this study
- Who is it for?
- Ages 2 to 3 years
- Conditions the study is for
- Poverty
- What is being tested?
- Recipe 4 Success and Usual practice Early Head Start
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2016to 20 Jan 2020
- 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 2 to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children must be receiving Early Head Start home visits and be at least 2 years old at the beginning of the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53706
About this study
The purpose of this study is to test the effectiveness of a new curriculum on toddlers' self-regulation skills and healthy eating habits. The curriculum is being delivered as part of Early Head Start home visits and compared to the effectiveness of usual practice Early Head Start home visits.
- Conditions
- Poverty
- Being tested
- Recipe 4 Success, Usual practice Early Head Start
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recipe 4 SuccessBehavioural
Home visitors teach parents about children's self-regulation skills and healthy eating habits. The home visitors then teach parents how to sensitively scaffold the development of their toddlers' self-regulation skills in the context of cooking and snack preparation lessons. Prior research shows that self-regulation skills in early childhood predict long-term health indicators, such as BMI. Prior research also shows that children who are involved in the preparation of healthier foods are more likely to eat them.
Usual practice Early Head StartBehavioural
Home visitors will continue to deliver usual practice Early Head Start home visits that follow a standard curriculum and are tailored on an ongoing basis to meet individual family needs.
| Study group | Role | What they receive |
|---|---|---|
| Recipe 4 Success | Experimental | For 12 weeks, home visitors will stop delivering the usual practice Early Head Start home visits and deliver the Recipe 4 Success curriculum instead. At the end of 12 weeks, home visitors will resume usual practice Early Head Start home visits. Receives: Behavioral: Recipe 4 Success |
| Usual practice Early Head Start | Active comparator | Home visitors will continue to deliver usual practice Early Head Start home visits that follow a standard curriculum and are tailored on an ongoing basis to meet individual family needs. Receives: Behavioral: Usual practice Early Head Start |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in children's healthy eating habits: Body mass index
Healthy eating habits will be assessed through change in body mass index
Measured: Baseline / up to 18 months
Change in children's healthy eating habits: Food diaries
Healthy eating habits will be assessed through change in consumption of fruits/vegetables and junk food, as assessed with 24-hour food diaries
Measured: Baseline / up to 18 months
Change in children's healthy eating habits: Parent reports
Healthy eating habits will be assessed through parent survey of pickiness, etc.; mean scores reported from 5-point Likert scales with higher scores indicating healthier eating habits
Measured: Baseline / up to 18 months
Change in children's self-control skills: Direct testing
Children's self-control skills will be assessed through direct testing (e.g., snack delay task)
Measured: Baseline / up to 18 months
Change in children's self-control skills: Video interactions
Children's self-control skills will be assessed through parent-child interactions, rated on Likert scale from video recordings; mean score reported between 1 = almost never and 5 = almost always
Measured: Baseline / up to 18 months
Change in children's self-control skills: Parent ratings
Children's self-control skills will be assessed through parent ratings on standardized behavior checklists; mean scores reported from 3- or 5-point Likert scales with higher scores indicating greater self-control
Measured: Baseline / up to 18 months
Change in parents' sensitive/responsiveness: Video interactions
Parents' sensitive/responsiveness will be assessed through parent-child interactions, rated on Likert scale from video recordings; mean score reported between 1 = almost never and 5 = almost always
Measured: Baseline / up to 18 months
Change in parents' sensitive/responsiveness: Parent ratings
Parents' sensitive/responsiveness will be assessed through parent ratings on standardized surveys; mean scores reported from 5-point Likert scales with higher scores indicating greater sensitive/responsiveness
Measured: Baseline / up to 18 months
Secondary outcomes (1)
Change in children's sleep habits: Parent reports
Sleep habits will be assessed through parent survey; mean scores reported from 5-point Likert scales with higher scores indicating better sleep habits
Measured: Baseline / up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start8 Nov 2016
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
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 PovertyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Families are blocked within home visitor caseload and randomly assigned to receive the new curriculum or usual practice Early Head Start home visits for 12 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 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, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958214
- Sponsor's protocol ID
- 2016-0465
- Other IDs
- A271000, SOHE/SOHE/SOHE*ADMIN
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2017
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Engbretson AM, Nix RL, Park YR, Gill S, Hostetler ML. Elaboration of parents' schemas of their children: Unique relations to sensitivity and learning support among families living in poverty. J Fam Psychol. 2023 Apr;37(3):318-323. doi: 10.1037/fam0001048. Epub 2023 Jan 2.
PubMed 36595449
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start
- ClinicalTrials.gov ID
- NCT03958214
- Acronym / sponsor ID
- 2016-0465
- Conditions
- Poverty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 21 May 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.
The purpose of this study is to test the effectiveness of a new curriculum on toddlers' self-regulation skills and healthy eating habits. The curriculum is being delivered as part of Early Head Start home visits and compared to the effectiveness of usual practice Early Head Start home visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Families are blocked within home visitor caseload and randomly assigned to receive the new curriculum or usual practice Early Head Start home visits for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Recipe 4 Success | Experimental | Behavioral: Recipe 4 SuccessFor 12 weeks, home visitors will stop delivering the usual practice Early Head Start home visits and deliver the Recipe 4 Success curriculum instead. At the end of 12 weeks, home visitors will resume usual practice Early Head Start home visits. |
| Usual practice Early Head Start | Active comparator | Behavioral: Usual practice Early Head StartHome visitors will continue to deliver usual practice Early Head Start home visits that follow a standard curriculum and are tailored on an ongoing basis to meet individual family needs. |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children must be receiving Early Head Start home visits and be at least 2 years old at the beginning of the study.
Key exclusion criteria (1 listed)
- -
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 SuccessHome visitors teach parents about children's self-regulation skills and healthy eating habits. The home visitors then teach parents how to sensitively scaffold the development of their toddlers' self-regulation skills in the context of cooking and snack preparation lessons. Prior research shows that self-regulation skills in early childhood predict long-term health indicators, such as BMI. Prior research also shows that children who are involved in the preparation of healthier foods are more likely to eat them. | Behavioural | Recipe 4 Success |
| Usual practice Early Head StartHome visitors will continue to deliver usual practice Early Head Start home visits that follow a standard curriculum and are tailored on an ongoing basis to meet individual family needs. | Behavioural | Usual practice Early Head Start |
Primary outcome
Change in children's healthy eating habits: Body mass index
Time frame: Baseline / up to 18 months
Healthy eating habits will be assessed through change in body mass index
Change in children's healthy eating habits: Food diaries
Time frame: Baseline / up to 18 months
Healthy eating habits will be assessed through change in consumption of fruits/vegetables and junk food, as assessed with 24-hour food diaries
Change in children's healthy eating habits: Parent reports
Time frame: Baseline / up to 18 months
Healthy eating habits will be assessed through parent survey of pickiness, etc.; mean scores reported from 5-point Likert scales with higher scores indicating healthier eating habits
Change in children's self-control skills: Direct testing
Time frame: Baseline / up to 18 months
Children's self-control skills will be assessed through direct testing (e.g., snack delay task)
Change in children's self-control skills: Video interactions
Time frame: Baseline / up to 18 months
Children's self-control skills will be assessed through parent-child interactions, rated on Likert scale from video recordings; mean score reported between 1 = almost never and 5 = almost always
Change in children's self-control skills: Parent ratings
Time frame: Baseline / up to 18 months
Children's self-control skills will be assessed through parent ratings on standardized behavior checklists; mean scores reported from 3- or 5-point Likert scales with higher scores indicating greater self-control
Change in parents' sensitive/responsiveness: Video interactions
Time frame: Baseline / up to 18 months
Parents' sensitive/responsiveness will be assessed through parent-child interactions, rated on Likert scale from video recordings; mean score reported between 1 = almost never and 5 = almost always
Change in parents' sensitive/responsiveness: Parent ratings
Time frame: Baseline / up to 18 months
Parents' sensitive/responsiveness will be assessed through parent ratings on standardized surveys; mean scores reported from 5-point Likert scales with higher scores indicating greater sensitive/responsiveness
1 secondary outcome
Change in children's sleep habits: Parent reports
Time frame: Baseline / up to 18 months
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 27 Feb 2020.
- Derived from this study: PubMed 36595449Engbretson AM, Nix RL, Park YR, Gill S, Hostetler ML. Elaboration of parents' schemas of their children: Unique relations to sensitivity and learning support among families living in poverty. J Fam Psychol. 2023 Apr;37(3):318-323. doi: 10.1037/fam0001048. Epub 2023 Jan 2.
- Individual participant dataSharing planned: Undecided
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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, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recipe 4 Success and Usual practice Early Head Start in people with Poverty, run by University of Wisconsin, Madison at 1 site in United States.
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 1 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 children's healthy eating habits: Body mass index (time frame: Baseline / up to 18 months). The study lists 8 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 NCT03958214, 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 27 Feb 2020.