An interventional study of Behavior Change Intervention in Obesity, Infant, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 50 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive health coaching, patient-directed behavior change support by mobile health, and usual clinical care.
Behavioral: Behavior Change Intervention
Participants will receive usual clinical care.
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.
Arm specific retention rates at 18 months
The retention rate will be defined as the proportion of enrolled individuals who complete infant age 12-months study visits (study month 18) according to each arm.
Time frame: Up to 18 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Columbia University