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

NCT04989738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-08-10

No results posted yet for this study

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

Interventions

BEHAVIORAL

THRIVE intervention

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.

BEHAVIORAL

Active Control

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

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Weeks
Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2021-09-01
Completion
2021-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04989738 on ClinicalTrials.gov