NCT05225649Completed
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
Source: ClinicalTrials.gov · Last updated 8 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 17 Jan 2022
- Start date
- 14 Jan 2022
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Columbia University
- Diseases
- Obesity
- NCT number
- NCT05225649
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 14 Jan 2022 to the primary completion date, 1 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Chronic medical conditions that affect nutrition or prohibit regular exercise or alter weight status such as:
- 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
- Sickle cell disease
- Zika infection
- 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)
Lab values
- Diseases associated with glucose metabolism
- Other active medical problems detected by examination or laboratory testing
Other
- Multiple gestation
- Pre-pregnancy body mass index \<18.5 kg/m2 \>40
- Major fetal anomaly
- Fetal genetic abnormality
- Planned termination of pregnancy
- Lupus
- Multiple sclerosis
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.