NCT05225649

Health e-Baby: Trial to Reduce Obesity Risk Factors During the First 1,000 Days

Pilot Randomized Controlled Trial to Reduce Obesity Risk Factors During the First 1,000 Days

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Specific Aim: Feasibility of a Pilot Randomized Controlled Trial (RCT) in Pregnancy and Infancy to Reduce Childhood Obesity Risk Factors in Early Life. The main outcomes are feasibility of the intervention components and data collection. Study will use maternal body mass index (BMI) and child weight-for-length outcomes to estimate sample size needed for a full-scale trial to test intervention efficacy. Primary analysis for full-scale trial power and sample size calculations will be conducted using child weight-for-length data at Child Age 12 Months Visit. Data collected will inform future interventions.

Detailed description

Early life interventions to prevent childhood obesity among disproportionately burdened populations are needed to reduce childhood obesity. The overall goal of this study is to test the feasibility of a pilot randomized controlled trial to promote healthy maternal weight in pregnancy and post-partum and normal child weight-for-length from birth to age 12 months. The study will include 50 women (enrollment up to 70 to account for potential attrition) in pregnancy and their child through age 12 months to examine rates of study component completion, study component satisfaction, and retention. Women enrolled in the intervention will participate in virtual health coaching and receive self-directed behavior change materials by text and email. The results of this study will help us develop efficacious childhood obesity prevention interventions and determine how many study participants would be needed for a full-scale trial. Ultimately, this research could open new avenues for studying ways to promote health starting early in life.

Conditions

• Obesity, Infant

Interventions

Type	Name	Description
BEHAVIORAL	Behavior Change Intervention	Health coaching sessions; self-monitoring: Fitbit, home scale, and app; personalized health information by mobile health: growth charts and age-specific health behavior information via text message and email; behavior change support by mobile health: family-based health behavior goal setting via chatbot; and usual clinical care.

Timeline

• Start date: 2022-01-14
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2022-02-04
• Last updated: 2024-11-08

Locations

1 site across 1 country: United States