ParentingTHRIVENCT04989738
Teaching Healthy Responsive Parenting During Infancy to Promote Vital Growth and dEvelopment (THRIVE) Study
A study testing THRIVE intervention in people with Parenting and Feeding Behavior, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Background. Unprecedented rates of overweight and obesity are seen in childhood1 with evidence suggesting that infancy may be a critical period for the development of this high weight trajectory. Read more about this study
- Who is it for?
- Ages 0 to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Parenting, Feeding Behavior, Sleep
- What is being tested?
- THRIVE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2020to 30 Nov 2021
- 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 0 to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- mothers of singleton infants
- born > 2500 g
- delivery between 37 and 42 weeks
- English speaking mother
- care provided at one of the CCHMC primary care locations (Hopple Street Health Primary Care Clinic, Pediatric Primary Care, or Fairfield Primary Care).
Who cannot join
- infant exposure to illicit drugs in utero [except Tetrahydrocannabinol (THC)]
- extensive care in the Neonatal Intensive Care Unit (>7 days)
- an infant congenital anomaly or neonatal condition that impacts feeding (e.g., cleft lip/palate, metabolic disease)
- plan to move from the Greater Cincinnati area within 1 year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hopple Street Neighborhood Primary Care Clinic
Cincinnati, Ohio, 45225
About this study
Background. Unprecedented rates of overweight and obesity are seen in childhood1 with evidence suggesting that infancy may be a critical period for the development of this high weight trajectory. This has led to a call for proposals for "understanding factors in infancy and early childhood (birth to 24 months) that influence obesity development (PA-18-032)." Objectives. The current study seeks to recruit a sample of mother-infant dyads to pilot a responsive parenting focused obesity prevention program delivered by behavior and development specialists in pediatric primary care. Methods. Approximately 80 mother-infant dyads will be recruited in pediatric primary care at their newborn visit and randomly assigned to one of two groups: a) Healthy Growth (new intervention) or b) Healthy Steps (as usual). We will obtain assessments of growth, feeding, and sleep throughout the study period for infants across five clinic visits and at-home measure completion. Research clinic visits will take place at their regularly scheduled well-child check visits at ages 1, 2, 4, and 6 mos and in-home measures will be completed monthly. The intervention program is hypothesized to show efficacy in both breast and formula fed infants as measured by the primary (i.e., BMI percentile and BMI z-score) and secondary outcomes (e.g., awareness of infant cues, use of alternative soothing strategies, when it is not time for a feeding).
Read the detailed description
PURPOSE OF STUDY AND OBJECTIVES
This study seeks to pilot deliver an early obesity prevention program in pediatric primary care that has been previously found efficacious when delivered via home visits. Modeled after the principles of the INSIGHT study, (cite) it uses a responsive parenting framework and provides developmentally tailored feeding, sleeping, and soothing guidance to parents of infants. Given its efficacy when delivered during home visits, study investigators aim to examine whether it can be adapted and delivered as part of the prevention work in integrated behavioral health (IBH) primary care practices. Currently, the integrated behavioral health model for prevention work follows the Healthy Steps program. Study investigators aim to compare these two prevention programs to examine if Teaching Healthy Responsive Parenting in Infancy to promote Vital growth and dEvelopment (THRIVE) improves outcomes (i.e., rapid weight gain, soothing, feeding, and sleep) above and beyond seeing a psychologist in a less focused way (Healthy Steps). The intervention will be delivered to 40 families by postdoctoral psychology fellows integrated in a pediatric primary care setting at each infant well-child check (WCC) visit during the first 6 months of life (e.g., 1, 2, 4, 6 mos), while another 40 families will receive care as usual (Healthy Steps) at each WCC during the first 6 months and constitute our control group. The THRIVE program aims to prevent rapid weight gain in infancy, as well as establish healthy eating, sleeping, and self-regulation habits early on in life, by teaching parents responsive parenting principles. More specific portions of the intervention will instruct parents a) to recognize infant hunger and satiety cues and use feeding more selectively in response to hunger only, b) to recognize other reasons for crying or fussy behavior and use alternative soothing strategies when these other reasons apply, c) how to lay the foundation for healthy infant sleep and respond to nighttime awakenings to promote self-soothing, and d) how to introduce complimentary foods at 6 mos, provide repeated exposure to a variety of healthy foods using positive role modeling, and allow infants to determine the amount consumed. In the current study, study investigators have proposed the following aims and hypotheses:
Primary Aims. To develop and pilot an obesity prevention program to be delivered in pediatric primary care at each infant well-child check (WCC) throughout the first 6 months (e.g., 1, 2, 4, 6 mos) and continue to follow families for assessment throughout the first year of life (e.g., follow-up at 9 mos). To evaluate the efficacy/magnitude of effect, feasibility, and acceptability of an individually-tailored, responsive parenting prevention intervention on parent's ability to 1) use alternative strategies to soothe their infant (besides feeding) and to 2) increase their responsive parenting skills, such as attunement, awareness of infant cues (hunger, satiety, sleepy, other fussiness), and responsive feeding from those in the control condition (Healthy Steps).
Primary Aim 1. To evaluate the feasibility of recruitment and retention of mother-infant dyads in primary care and refine assessment procedures to inform the design of an anticipated K23 application.
H1: The intervention format will demonstrate feasibility and acceptability via intervention session attendance and parent report.
Primary Aim 2. To examine if parents' strategies to soothe, feed, and put to sleep their infants differ between those in the intervention arm (THRIVE) compared to the control group (Healthy Steps).
H2a: Parents in the THRIVE group will demonstrate less frequent use of food to soothe infants and a greater use of a variety of other alternative soothing strategies when infant is not hungry.
H2b: Parents in the THRIVE group will report greater attunement, awareness of infant hunger and satiety cues, and responsive feeding.
Exploratory Aim. To examine weight trajectories of infants and estimate effect sizes to detect the relationship between sleep and feeding patterns. Infant anthropometrics will be assessed at ages 1, 2, 4, 6, and 9 mos with growth metrics derived based on US population references.3 H3: Infants in the THRIVE intervention will experience less rapid weight gain compared to infants in the control condition from birth - 9 months.
- Conditions
- Parenting, Feeding Behavior, Sleep, Parent-Child Relations
- Being tested
- THRIVE intervention, Active Control
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE interventionBehavioural
Also called responsive parenting
Parents learn responsive parenting skills, such as a) recognizing infant hunger and satiety cues and using feeding more selectively in response to hunger only, b) recognizing other reasons for crying or fussy behavior and using alternative soothing strategies when these other reasons apply, c) learning to lay the foundation for healthy infant sleep and respond to nighttime awakenings to promote self-soothing, and d) learning to introduce complimentary foods at 6 months, provide repeated exposure to a variety of healthy foods using positive role modeling, and allow infants to determine the amount consumed.
Active ControlBehavioural
Also called Care as Usual
Parents learn about development, safety, and positive parenting without a specific emphasis on feeding, sleep, and soothing.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE Condition | Experimental | Specifically, parents will learn responsive parenting skills, such as a) recognizing infant hunger and satiety cues and using feeding more selectively in response to hunger only, b) recognizing other reasons for crying or fussy behavior and using alternative soothing strategies when these other reasons apply, c) learning to lay the foundation for healthy infant sleep and respond to nighttime awakenings to promote self-soothing, and d) learning to introduce complimentary foods at 6 months, provide repeated exposure to a variety of healthy foods using positive role modeling, and allow infants to determine the amount consumed. Receives: Behavioral: THRIVE intervention |
| Care As Usual - Healthy Steps Model | Active comparator | Parents learn about development, safety, and positive parenting without a specific emphasis on feeding, sleep, and soothing. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Recruitment will be measured by number of participants able to be recruited in our time frame
Measured: birth to 9 months of age
Feasibility of Retention of Subjects
This will be measured by number of subjects who attend all sessions and complete the 6 month follow-up surveys
Measured: birth to 9 months of age
Secondary outcomes (1)
Weight-for-age z-scores
Weight-for-age z-scores will be calculated a long with conditional weight gain to measure rapid weight gain for preliminary efficacy.
Measured: birth to 9 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start5 Aug 2020
- Primary completion1 Sep 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989738
- Sponsor's protocol ID
- 2020-0599
- Acronym
- THRIVE
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consistent with the open science movement and with the directive of clinicaltrials.gov to include a data sharing plan in submissions, study investigators will have the following data sharing policy: Study investigators will share with other investigators (1) all individual participant data after deidentification, and (2) study management documents (protocol, statistical analysis plan, consent form, analytic code, data dictionary). These will be made available three months after publication of the primary article and ending five years after publication. Those requesting data will be required to submit a proposal to the PI. This will be reviewed by the investigative team for methodological soundness and scientific merit before data is shared. This plan is consistent with guidelines developed by the International Committee of Medical Journal Editors (Taichman et al., 2017).
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Healthy Responsive Parenting During Infancy to Promote Vital Growth and dEvelopment (THRIVE) Study
- ClinicalTrials.gov ID
- NCT04989738
- Acronym / sponsor ID
- THRIVE / 2020-0599
- Conditions
- Parenting, Feeding Behavior, Sleep, Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 4 Aug 2021 (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.
Background. Unprecedented rates of overweight and obesity are seen in childhood1 with evidence suggesting that infancy may be a critical period for the development of this high weight trajectory. This has led to a call for proposals for "understanding factors in infancy and early childhood (birth to 24 months) that influence obesity development (PA-18-032)." Objectives. The current study seeks to recruit a sample of mother-infant dyads to pilot a responsive parenting focused obesity prevention program delivered by behavior and development specialists in pediatric primary care. Methods. Approximately 80 mother-infant dyads will be recruited in pediatric primary care at their newborn visit and randomly assigned to one of two groups: a) Healthy Growth (new intervention) or b) Healthy Steps (as usual). We will obtain assessments of growth, feeding, and sleep throughout the study period for infants across five clinic visits and at-home measure completion. Research clinic visits will take place at their regularly scheduled well-child check visits at ages 1, 2, 4, and 6 mos and in-home measures will be completed monthly. The intervention program is hypothesized to show efficacy in both breast and formula fed infants as measured by the primary (i.e., BMI percentile and BMI z-score) and secondary outcomes (e.g., awareness of infant cues, use of alternative soothing strategies, when it is not time for a feeding).
Detailed description
PURPOSE OF STUDY AND OBJECTIVES
This study seeks to pilot deliver an early obesity prevention program in pediatric primary care that has been previously found efficacious when delivered via home visits. Modeled after the principles of the INSIGHT study, (cite) it uses a responsive parenting framework and provides developmentally tailored feeding, sleeping, and soothing guidance to parents of infants. Given its efficacy when delivered during home visits, study investigators aim to examine whether it can be adapted and delivered as part of the prevention work in integrated behavioral health (IBH) primary care practices. Currently, the integrated behavioral health model for prevention work follows the Healthy Steps program. Study investigators aim to compare these two prevention programs to examine if Teaching Healthy Responsive Parenting in Infancy to promote Vital growth and dEvelopment (THRIVE) improves outcomes (i.e., rapid weight gain, soothing, feeding, and sleep) above and beyond seeing a psychologist in a less focused way (Healthy Steps). The intervention will be delivered to 40 families by postdoctoral psychology fellows integrated in a pediatric primary care setting at each infant well-child check (WCC) visit during the first 6 months of life (e.g., 1, 2, 4, 6 mos), while another 40 families will receive care as usual (Healthy Steps) at each WCC during the first 6 months and constitute our control group. The THRIVE program aims to prevent rapid weight gain in infancy, as well as establish healthy eating, sleeping, and self-regulation habits early on in life, by teaching parents responsive parenting principles. More specific portions of the intervention will instruct parents a) to recognize infant hunger and satiety cues and use feeding more selectively in response to hunger only, b) to recognize other reasons for crying or fussy behavior and use alternative soothing strategies when these other reasons apply, c) how to lay the foundation for healthy infant sleep and respond to nighttime awakenings to promote self-soothing, and d) how to introduce complimentary foods at 6 mos, provide repeated exposure to a variety of healthy foods using positive role modeling, and allow infants to determine the amount consumed. In the current study, study investigators have proposed the following aims and hypotheses:
Primary Aims. To develop and pilot an obesity prevention program to be delivered in pediatric primary care at each infant well-child check (WCC) throughout the first 6 months (e.g., 1, 2, 4, 6 mos) and continue to follow families for assessment throughout the first year of life (e.g., follow-up at 9 mos). To evaluate the efficacy/magnitude of effect, feasibility, and acceptability of an individually-tailored, responsive parenting prevention intervention on parent's ability to 1) use alternative strategies to soothe their infant (besides feeding) and to 2) increase their responsive parenting skills, such as attunement, awareness of infant cues (hunger, satiety, sleepy, other fussiness), and responsive feeding from those in the control condition (Healthy Steps).
Primary Aim 1. To evaluate the feasibility of recruitment and retention of mother-infant dyads in primary care and refine assessment procedures to inform the design of an anticipated K23 application.
H1: The intervention format will demonstrate feasibility and acceptability via intervention session attendance and parent report.
Primary Aim 2. To examine if parents' strategies to soothe, feed, and put to sleep their infants differ between those in the intervention arm (THRIVE) compared to the control group (Healthy Steps).
H2a: Parents in the THRIVE group will demonstrate less frequent use of food to soothe infants and a greater use of a variety of other alternative soothing strategies when infant is not hungry.
H2b: Parents in the THRIVE group will report greater attunement, awareness of infant hunger and satiety cues, and responsive feeding.
Exploratory Aim. To examine weight trajectories of infants and estimate effect sizes to detect the relationship between sleep and feeding patterns. Infant anthropometrics will be assessed at ages 1, 2, 4, 6, and 9 mos with growth metrics derived based on US population references.3 H3: Infants in the THRIVE intervention will experience less rapid weight gain compared to infants in the control condition from birth - 9 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE Condition | Experimental | Behavioral: THRIVE interventionSpecifically, parents will learn responsive parenting skills, such as a) recognizing infant hunger and satiety cues and using feeding more selectively in response to hunger only, b) recognizing other reasons for crying or fussy behavior and using alternative soothing strategies when these other reasons apply, c) learning to lay the foundation for healthy infant sleep and respond to nighttime awakenings to promote self-soothing, and d) learning to introduce complimentary foods at 6 months, provide repeated exposure to a variety of healthy foods using positive role modeling, and allow infants to determine the amount consumed. |
| Care As Usual - Healthy Steps Model | Active comparator | Behavioral: Active ControlParents learn about development, safety, and positive parenting without a specific emphasis on feeding, sleep, and soothing. |
Who may qualify
- Ages
- 0 to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- mothers of singleton infants
- born > 2500 g
- delivery between 37 and 42 weeks
- English speaking mother
- care provided at one of the CCHMC primary care locations (Hopple Street Health Primary Care Clinic, Pediatric Primary Care, or Fairfield Primary Care).
Key exclusion criteria (4 listed)
- infant exposure to illicit drugs in utero [except Tetrahydrocannabinol (THC)]
- extensive care in the Neonatal Intensive Care Unit (>7 days)
- an infant congenital anomaly or neonatal condition that impacts feeding (e.g., cleft lip/palate, metabolic disease)
- plan to move from the Greater Cincinnati area within 1 year.
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 |
|---|---|---|
| THRIVE interventionAlso: responsive parentingParents learn responsive parenting skills, such as a) recognizing infant hunger and satiety cues and using feeding more selectively in response to hunger only, b) recognizing other reasons for crying or fussy behavior and using alternative soothing strategies when these other reasons apply, c) learning to lay the foundation for healthy infant sleep and respond to nighttime awakenings to promote self-soothing, and d) learning to introduce complimentary foods at 6 months, provide repeated exposure to a variety of healthy foods using positive role modeling, and allow infants to determine the amount consumed. | Behavioural | THRIVE Condition |
| Active ControlAlso: Care as UsualParents learn about development, safety, and positive parenting without a specific emphasis on feeding, sleep, and soothing. | Behavioural | Care As Usual - Healthy Steps Model |
Primary outcome
Feasibility of recruitment
Time frame: birth to 9 months of age
Recruitment will be measured by number of participants able to be recruited in our time frame
Feasibility of Retention of Subjects
Time frame: birth to 9 months of age
This will be measured by number of subjects who attend all sessions and complete the 6 month follow-up surveys
1 secondary outcome
Weight-for-age z-scores
Time frame: birth to 9 months of age
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 10 Aug 2022.
- Individual participant dataSharing planned: Yes. Consistent with the open science movement and with the directive of clinicaltrials.gov to include a data sharing plan in submissions, study investigators will have the following data sharing policy: Study investigators will share with other investigators (1) all individual participant data after deidentification, and (2) study management documents (protocol, statistical analysis plan, consent form, analytic code, data dictionary). These will be made available three months after publication of the primary article and ending five years after publication. Those requesting data will be required to submit a proposal to the PI. This will be reviewed by the investigative team for methodological soundness and scientific merit before data is shared. This plan is consistent with guidelines developed by the International Committee of Medical Journal Editors (Taichman et al., 2017).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE intervention in people with Parenting and Feeding Behavior, run by Children's Hospital Medical Center, Cincinnati 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 5 inclusion and 4 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 10 Aug 2022. 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?
Feasibility of recruitment (time frame: birth to 9 months of age). The study lists 2 primary outcomes in all. 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 10 Aug 2022.