Teaching Healthy Responsive Parenting During Infancy to Promote Vital Growth and dEvelopment (THRIVE) Study

NCT04989738 | Completed

• 1 other identifier: 2020-0599
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Parenting; Feeding Behavior; Sleep; Parent-Child Relations

Outcome Measures

Primary Outcomes (2)

• Feasibility of recruitment

  Recruitment will be measured by number of participants able to be recruited in our time frame

  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

  birth to 9 months of age

Secondary Outcomes (1)

• Weight-for-age z-scores

  birth to 9 months of age

Study Arms (2)

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.

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.

Behavioral: Active Control

Interventions

THRIVE intervention BEHAVIORAL

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.

Also known as: responsive parenting

THRIVE Condition

Active Control BEHAVIORAL

Parents learn about development, safety, and positive parenting without a specific emphasis on feeding, sleep, and soothing.

Also known as: Care as Usual

Care As Usual - Healthy Steps Model

Eligibility Criteria

• Age: 0 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Hopple Street Neighborhood Primary Care Clinic

Cincinnati, Ohio, 45225, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

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

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: August 5, 2020
• Primary Completion: September 1, 2021
• Study Completion: November 30, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be made available 3 months after publication and for 5 years following publication.
• Access Criteria: 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).

Locations

US (1)