What side effects are associated with this type of intervention?

Common treatments for obesity include pharmacotherapy with drugs like phentermine-topiramate. Known side effects of phentermine-topiramate include dry mouth, constipation, insomnia, dizziness, and an increased heart rate. These side effects are generally more pronounced during the initial phase of treatment and may diminish over time. It is important for patients to discuss these potential side effects with their healthcare provider to ensure the benefits outweigh the risks.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including GLP-1 receptor agonists like liraglutide (Saxenda) and semaglutide (Wegovy). These medications work by mimicking the hormone GLP-1, which helps regulate appetite and food intake. Other approved medications include phentermine-topiramate (Qsymia) and naltrexone-bupropion (Contrave), which act on the central nervous system to reduce appetite. These treatments are similar to those being studied in the feasibility study, which aims to assess interventions for reducing obesity risk factors in early life.

What other types of research exist?

Promising, novel alternatives to feasibility studies for obesity treatment in 2024 include personalized medicine approaches, multidisciplinary strategies involving various healthcare professionals, and the integration of technology such as mobile health applications and telemedicine for improved patient engagement and monitoring.

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Behavior Change Intervention for Childhood Obesity

N/A

Waitlist Available

Led By Ali Mencin, MD

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

No Placebo-Only Group

Summary

This trial tests if online health coaching and sending helpful materials can help pregnant women and their babies stay healthy. It focuses on preventing childhood obesity by encouraging good habits in mothers. The study targets pregnant women and their babies, especially those more likely to face obesity.

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arm specific retention rates at 18 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavior Change Intervention

2022

N/A

~50

0 / 5Eligibility criteria met

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.