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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
Must not have
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, 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, other active medical problems detected by examination or laboratory testing, inability to complete study visits or intervention components, unwillingness or inability to commit to an 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
Fetal genetic abnormality
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a chronic condition that affects my nutrition, exercise, or weight.
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My fetus has a genetic abnormality.

Timeline

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for obesity include dietary interventions, behavioral therapy, and lifestyle modifications. Dietary interventions often involve reducing caloric intake through specific diet plans, such as low-carbohydrate or Mediterranean diets, which help in weight loss and improve metabolic health. Behavioral therapy focuses on changing eating and activity habits through techniques like self-monitoring, goal setting, and problem-solving, which enhance adherence to dietary and exercise regimens. Lifestyle modifications incorporate increased physical activity and structured exercise programs to boost energy expenditure and improve cardiovascular health. These treatments are crucial for obesity patients as they not only promote weight loss but also reduce the risk of comorbidities such as type 2 diabetes, hypertension, and cardiovascular diseases, thereby improving overall health and quality of life.
Evaluation of a novel pre-treatment model of nutrition care for patients with head and neck cancer receiving chemoradiotherapy.Evidences of a New Psychobiotic Formulation on Body Composition and Anxiety.Assessment and Optimisation of Lung Cancer Patients for Treatment with Curative Intent.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,448 Previous Clinical Trials
2,531,440 Total Patients Enrolled
40 Trials studying Obesity
5,994 Patients Enrolled for Obesity
Doris Duke Charitable FoundationOTHER
62 Previous Clinical Trials
260,048 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
~5 spots leftby Nov 2024