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

NCT05225649 | Completed DMC

• 1 other identifier: AAAT7915
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Infant

Keywords

First 1,000 days; Mobile Health; Behavior Change Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 18 months

Study Arms (2)

Behavior Change Intervention

EXPERIMENTAL

Participants will receive health coaching, patient-directed behavior change support by mobile health, and usual clinical care.

Behavioral: Behavior Change Intervention

Control

NO INTERVENTION

Participants will receive usual clinical care.

Interventions

Behavior Change Intervention BEHAVIORAL

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.

Behavior Change Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years at time of enrollment
• Gestational age 10-20 weeks at time of enrollment
• Receiving primary care or prenatal care at Columbia/New-York Presbyterian site
• Planned delivery at Columbia/New-York Presbyterian with planned continuation of primary care (postpartum and pediatric) at Columbia/New-York Presbyterian
• Ability to read and respond to questions in English or Spanish
• Smart phone ownership
• Willingness to receive information by smart phone for 18-month intervention and follow-up duration
• Willingness to be randomized into an observational study or an intervention and complete all study components
• Gives permission to participate in receiving messages to their smart phone and email
• Gives permission to complete all study procedures
• Has a physician's clearance for light to moderate physical activity
• Has an active email address
• Capable of providing informed consent
• Has access to Wi-Fi connection in their household

You may not qualify if:

• Multiple gestation
• Pre-pregnancy body mass index \<18.5 kg/m2 \>40
• Major fetal anomaly
• Fetal genetic abnormality
• Planned termination of pregnancy
• Chronic medical conditions that affect nutrition or prohibit regular exercise or alter weight status such as:
• Diseases associated with glucose metabolism
• Diabetes (Type 1, type 2)
• Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis)
• History of gastric bypass/gastric sleeve
• Uncontrolled thyroid disease (hypo or hyperthyroidism)
• Condition requiring enteral tube feeding
• Congenital or acquired heart disease that impacts nutritional needs and physical activity ability
• HIV/AIDS
• Kidney disease

Sponsors & Collaborators

• Columbia University: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Mencin, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be identified by a participant code to the care provider, investigator, and outcomes assessor until primary analysis is complete.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 4, 2022
• Study Start: January 14, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)