Infant BehaviorNCT02438878
Supporting Baby Behavior Through Pediatric Offices
A study testing Baby Behavior in people with Infant Behavior and Feeding Behavior, run by University of California, Davis at 1 site in United States.
Trial summary
The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant Behavior, Feeding Behavior, Breastfeeding
- What is being tested?
- Baby Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 16 Feb 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Will attend a participating pediatric clinic for her well-baby visits
- Primiparous, singleton pregnancy
- Currently enrolled in WIC
- At least 18 years of age
- Speaks and reads English or Spanish
- Has a telephone and access to the internet
- Plans to stay in the area for 6 months after birth of infant
- Abstained from smoking during pregnancy
Who cannot join
- Gave birth before 37 weeks gestation
- She and/or her infant has health condition(s) or known health risks that contraindicate breastfeeding
- She and/or her infant has health condition(s) or known health risks that impact infant growth and development
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants.
Read the detailed description
The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants. The intervention, currently used in all California WIC agencies, teaches caregivers to recognize and understand healthy infant behaviors such as the range of infant cues and common patterns for sleep and crying. This project will also evaluate the acceptance, knowledge transfer, and use of the tools by health care providers and medical staff. It is expected that trained staff will be prepared to share Baby Behavior messages with their patients and that the information will be delivered quickly and easily during well-baby visits.
- Conditions
- Infant Behavior, Feeding Behavior, Breastfeeding, Pediatric Obesity
- Being tested
- Baby Behavior
- Medical subject headings
- Infant Behavior, Feeding Behavior, Breast Feeding, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby BehaviorBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Baby Behavior | Experimental | The intervention is comprised of 2 components: HCP and medical staff training and participant education. The trainings will be video-based and aim to build providers' knowledge and skills to support parents' recognition and understanding of common healthy infant behaviors that may be misinterpreted by parents. The intervention does not include any specific recommendations for infant feeding, nor does it include any information related to the assessment, diagnosis or treatment for any medical condition.
After completion of the intervention trainings, health care providers and medical staff will be asked to use what they learned with the mothers of infants in their care. Short handouts for mothers will be provided as tools to reinforce the verbal education. All educational materials will be focused only on supporting parents' abilities to recognize and understand common, healthy infant behaviors. Receives: Behavioral: Baby Behavior |
| Control | No intervention | The control arm will continue with standard well-baby visit practices during the intervention period and will be offered the option to complete the Baby Behavior online trainings for continuing education credits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-for-length growth trajectory
Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards
Measured: Up to 6 months postpartum
Secondary outcomes (7)
Infant feeding practices
Breastfeeding duration and exclusivity, introduction of non-breast milk foods and fluids, use of sugary beverages, and intake of formula and select complementary foods
Measured: 1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
Maternal depressive symptoms
Edinburgh Postnatal Depression Scale
Measured: 2 weeks and 6 months postpartum
Maternal self-efficacy
Perceived Maternal Parenting Self-Efficacy
Measured: 1 week, 2 months, and 6 months postpartum
Maternal perceived stress
Perceived Stress Scale Short-Form
Measured: 1 week, 2 months, and 6 months postpartum
Infant sleep patterns
Brief Infant Sleep Questionnaire
Measured: 2 months and 6 months postpartum
Infant development
Ages and Stages Questionnaire
Measured: 2 months, 4 months, and 6 months postpartum
Infant eating behavior
Baby Eating Behavior Questionnaire
Measured: 4 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMar 2015
- Primary completion7 Dec 2016
- Study completion16 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant BehaviorStudies 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
- Masking
- None (open label)
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Heinig, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438878
- Sponsor's protocol ID
- 687861
- Other IDs
- WIC NEI-12-TX
- Status last verified
- Sep 2018
- First submitted
- 6 May 2015
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Baby Behavior Through Pediatric Offices
- ClinicalTrials.gov ID
- NCT02438878
- Acronym / sponsor ID
- 687861
- Conditions
- Infant Behavior, Feeding Behavior, Breastfeeding, Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 16 Feb 2017 (actual)
- First posted
- 8 May 2015 (estimated)
- 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 primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants.
Detailed description
The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants. The intervention, currently used in all California WIC agencies, teaches caregivers to recognize and understand healthy infant behaviors such as the range of infant cues and common patterns for sleep and crying. This project will also evaluate the acceptance, knowledge transfer, and use of the tools by health care providers and medical staff. It is expected that trained staff will be prepared to share Baby Behavior messages with their patients and that the information will be delivered quickly and easily during well-baby visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baby Behavior | Experimental | Behavioral: Baby BehaviorThe intervention is comprised of 2 components: HCP and medical staff training and participant education. The trainings will be video-based and aim to build providers' knowledge and skills to support parents' recognition and understanding of common healthy infant behaviors that may be misinterpreted by parents. The intervention does not include any specific recommendations for infant feeding, nor does it include any information related to the assessment, diagnosis or treatment for any medical condition. After completion of the intervention trainings, health care providers and medical staff will be asked to use what they learned with the mothers of infants in their care. Short handouts for mothers will be provided as tools to reinforce the verbal education. All educational materials will be focused only on supporting parents' abilities to recognize and understand common, healthy infant behaviors. |
| Control | No intervention | –The control arm will continue with standard well-baby visit practices during the intervention period and will be offered the option to complete the Baby Behavior online trainings for continuing education credits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Will attend a participating pediatric clinic for her well-baby visits
- Primiparous, singleton pregnancy
- Currently enrolled in WIC
- At least 18 years of age
- Speaks and reads English or Spanish
Key exclusion criteria (3 listed)
- Gave birth before 37 weeks gestation
- She and/or her infant has health condition(s) or known health risks that contraindicate breastfeeding
- She and/or her infant has health condition(s) or known health risks that impact infant growth and development
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 |
|---|---|---|
| Baby Behavior | Behavioural | Baby Behavior |
Primary outcome
Weight-for-length growth trajectory
Time frame: Up to 6 months postpartum
Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards
7 secondary outcomes
Infant feeding practices
Time frame: 1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
Maternal depressive symptoms
Time frame: 2 weeks and 6 months postpartum
Maternal self-efficacy
Time frame: 1 week, 2 months, and 6 months postpartum
Maternal perceived stress
Time frame: 1 week, 2 months, and 6 months postpartum
Infant sleep patterns
Time frame: 2 months and 6 months postpartum
Infant development
Time frame: 2 months, 4 months, and 6 months postpartum
Infant eating behavior
Time frame: 4 months postpartum
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 Sep 2018.
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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.
Jane Heinig, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Behavior in people with Infant Behavior and Feeding Behavior, run by University of California, Davis 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 8 inclusion and 3 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 Sep 2018. 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?
Weight-for-length growth trajectory (time frame: Up to 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2018.