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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Infant
• Intervention / Treatment: Behavioral: Behavior Change Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Woo Baidal, MD, MPH; Phone Number: 212-305-5903; Email: jw3286@cumc.columbia.edu
• Study Contact Backup: Name: Ivette Partida; Email: ip2359@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Cancer
• Uncontrolled autoimmune disease
• Lupus
• Multiple sclerosis
• Sickle cell disease
• Zika infection
• Taking or planning to take certain prescription medications including high dose glucocorticoids, atypical antipsychotics associated with weight gain (such as risperdal (risperidone), clozapine (clozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.), or other prescription weight loss medications
• Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer
• Personal history of cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months
• Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
• Other active medical problems detected by examination or laboratory testing
• Inability to complete study visits or intervention components
• Unwillingness or inability to commit to a 18-month research study for them or their child, including plans to move away
• Plans to be in a different geographic area within the next 2 years
• Unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavior Change Intervention; Participants will receive health coaching, patient-directed behavior change support by mobile health, and usual clinical care.	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.
No Intervention: Control; Participants will receive usual clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Doris Duke Charitable Foundation
• Investigators: Principal Investigator: Jennifer Woo Baidal, MD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Mobile Health; First 1,000 days; Behavior Change Intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: AAAT7915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No