Status:
COMPLETED
Health e-Baby: Trial to Reduce Obesity Risk Factors During the First 1,000 Days
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Doris Duke Charitable Foundation
Conditions:
Obesity, Infant
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 interv...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05225649
Start Date
January 14 2022
End Date
September 1 2024
Last Update
November 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University
New York, New York, United States, 10032