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

Columbia University

Status

Completed

Conditions

Obesity, Infant

Treatments

Behavioral: Behavior Change Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05225649

AAAT7915

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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