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Behavior Change Intervention for Childhood Obesity

N/A

Waitlist Available

Led By Jennifer Woo Baidal, MD, MPH

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gestational age 10-20 weeks at time of enrollment

Age 18-50 years at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

Study Summary

This trial will test the feasibility of an intervention to reduce childhood obesity risk factors in early life. The main outcomes are feasibility of the intervention components and data collection. child weight-for-length outcomes will be used to estimate sample size needed for a full-scale trial to test intervention efficacy.

Who is the study for?

This trial is for pregnant individuals aged 18-50, within 10-20 weeks of gestation, receiving care at Columbia/New-York Presbyterian. They must own a smartphone, speak English or Spanish, and be willing to participate in an 18-month study involving smart phone communication. Exclusions include multiple pregnancies, certain pre-existing conditions like uncontrolled thyroid disease or diabetes, and those on medications that affect weight.Check my eligibility

What is being tested?

The Health e-Baby trial tests the feasibility of a behavior change intervention during pregnancy and infancy to reduce childhood obesity risk factors. It's a pilot randomized controlled trial focusing on maternal BMI and child weight-for-length at age 12 months to plan for larger future trials.See study design

What are the potential side effects?

Since this is a behavioral intervention focused on reducing obesity risks through lifestyle changes rather than medication or medical procedures, there are no direct side effects as typically associated with drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 20 weeks pregnant.

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I am between 18 and 50 years old.

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I am able to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Arm specific retention rates at 18 months

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavior Change InterventionExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 Intervention

Participants will receive usual clinical care.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,783 Total Patients Enrolled

40 Trials studying Obesity

5,944 Patients Enrolled for Obesity

Doris Duke Charitable FoundationOTHER

61 Previous Clinical Trials

260,075 Total Patients Enrolled

1 Trials studying Obesity

23 Patients Enrolled for Obesity

Jennifer Woo Baidal, MD, MPHPrincipal InvestigatorColumbia University

2 Previous Clinical Trials

371 Total Patients Enrolled

1 Trials studying Obesity

80 Patients Enrolled for Obesity

Media Library

Behavior Change Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05225649 — N/A

Obesity Research Study Groups: Control, Behavior Change Intervention

Obesity Clinical Trial 2023: Behavior Change Intervention Highlights & Side Effects. Trial Name: NCT05225649 — N/A

Behavior Change Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05225649 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 50 and over eligible to take part in the research study?

"For this medical trial, individuals aged 18-50 are being sought out as potential participants."

Answered by AI

What criteria must participants fulfill to be eligible for this research?

"This clinical trial is seeking 70 participants in the age range of 18-50 with obesity. Qualifying candidates must meet the following criteria: be between 10-16 weeks gestational age at enrollment, have primary care or prenatal care from Columbia/New york Presbyterian, agree to deliver and receive postpartum and pediatric care from same centre, comprehend English or Spanish, possess a smartphone, consent to receiving information on their phone for an eighteen month intervention period plus followup duration, give permission to participate in messaging via email and smart device as well as complete all study activities."

Answered by AI

How many individuals can potentially participate in this research study?

"Affirmative. According to clinicaltrials.gov, this research project is actively looking for volunteers, with the initial post having been published on January 14th 2022 and last modified on February 3rd 2022. 70 people from a single centre are needed as part of the trial."

Answered by AI

Are there any opportunities for enrolment in this experiment?

"According to information uploaded on clinicaltrials.gov, this medical experiment is actively seeking out participants. It was first posted in mid-January of 2021 and underwent a recent amendment at the beginning of February 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jennifer Woo Baidal 2022. "Health e-Baby: Trial to Reduce Obesity Risk Factors During the First 1,000 Days". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05225649.