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

Completed · Not applicable

Conditions studied: Parenting, Feeding Behavior, Sleep, Parent-Child Relations

In brief

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).

Key facts

Study ID

NCT04989738

Run by

Children's Hospital Medical Center, Cincinnati

People needed

65

Starts

2020-08-05

Expected to finish

2021-11-30

Last updated by the study team

2022-08-10

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Hopple Street Neighborhood Primary Care Clinic — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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