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

Primary Purpose

Obesity, Infant

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavior Change Intervention
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity, Infant focused on measuring First 1,000 days, Mobile Health, Behavior Change Intervention

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-50 years at time of enrollment
  • Gestational age 10-16 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

Sites / Locations

  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavior Change Intervention

Control

Arm Description

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

Participants will receive usual clinical care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2022
Last Updated
February 11, 2023
Sponsor
Columbia University
Collaborators
Doris Duke Charitable Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05225649
Brief Title
Health e-Baby: Trial to Reduce Obesity Risk Factors During the First 1,000 Days
Official Title
Pilot Randomized Controlled Trial to Reduce Obesity Risk Factors During the First 1,000 Days
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Doris Duke Charitable Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Infant
Keywords
First 1,000 days, Mobile Health, Behavior Change Intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Participants will be identified by a participant code to the care provider, investigator, and outcomes assessor until primary analysis is complete.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavior Change Intervention
Arm Type
Experimental
Arm Description
Participants will receive health coaching, patient-directed behavior change support by mobile health, and usual clinical care.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive usual clinical care.
Intervention Type
Behavioral
Intervention Name(s)
Behavior Change Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arm specific retention rates at 18 months
Description
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.
Time Frame
Up to 18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Woo Baidal, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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