What side effects are associated with this type of intervention?

Behavioral and educational interventions for obesity, such as cognitive-behavioral therapy and lifestyle counseling, generally have minimal side effects but may include temporary emotional discomfort. Pharmacotherapy options, such as GLP-1 receptor agonists (e.g., liraglutide and semaglutide), can cause gastrointestinal side effects like nausea, vomiting, and diarrhea. Orlistat may lead to gastrointestinal issues such as oily stools and flatulence. Discussing these potential side effects with a healthcare provider is crucial to tailor the treatment plan to individual needs and tolerances.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including lorcaserin, orlistat, and semaglutide. Lorcaserin, which acts as a serotonin receptor agonist, was approved for weight management but was later withdrawn due to safety concerns. Orlistat, a lipase inhibitor, has been approved for long-term use and works by reducing fat absorption from the diet. Semaglutide, a GLP-1 receptor agonist, has shown significant weight loss benefits and is used in conjunction with lifestyle interventions such as diet and exercise. These medications are often part of a comprehensive treatment plan that includes behavioral and educational interventions to promote sustainable weight loss and improve overall health.

What other types of research exist?

Promising novel alternatives to Lifestyle Modification Programs for obesity treatment in 2024 include: 1) Pharmacological treatments such as GLP-1 receptor agonists (e.g., semaglutide) which have shown significant weight loss effects. 2) Anti-obesity medications like bupropion/naltrexone and liraglutide. 3) Technological innovations such as mobile health (mHealth) interventions and web-based counseling which provide accessible and personalized support. 4) Surgical options like endoscopic sleeve gastroplasty, a less invasive procedure compared to traditional bariatric surgery. These alternatives offer effective and diverse approaches to managing obesity.

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Nutrition and Physical Activity Program for Obesity (HMHC Trial)

N/A

Waitlist Available

Led By Diane C Berry, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

age 18 years or older

a BMI > 25th percentile for age and gender

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (time 1), time 3 (after 6 months with no contact from the study staff, approximately 15 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program of nutrition and exercise education for overweight Hispanic mothers and their young children, followed by several months of regular check-ins. The goal is to help mothers lose weight and improve health habits while preventing excessive weight gain in their children. The study targets Hispanic families to reduce future health risks like diabetes and heart disease.

Who is the study for?

This trial is for overweight or obese Hispanic mothers who understand Spanish, are 18 years or older with a BMI over 25, and their children aged 3-5 with a BMI above the 25th percentile. Participants should have limited English skills and low acculturation scores. Both mother and child must live together and consent to join the study.

What is being tested?

The study tests a 12-week program combining nutrition education, exercise guidance, coping skills training, followed by six months of support. It aims to improve body fat levels, weight management, health habits, and self-confidence in both mothers and young children.

What are the potential side effects?

While not explicitly stated for this educational intervention trial on nutrition and physical activity, potential side effects may include muscle soreness from new exercises or dietary changes such as gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My BMI is above the 25th percentile for my age and gender.

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My child is between 3 and 5 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (time 1), time 3 (after 6 months with no contact from the study staff, approximately 15 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (time 1), time 3 (after 6 months with no contact from the study staff, approximately 15 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (time 1), time 3 (after 6 months with no contact from the study staff, approximately 15 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

Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3

Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2

Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2

+21 more

Secondary study objectives

Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2

Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3

Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2

+13 more

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: Nutrition and Physical Activity InterventionExperimental Treatment1 Intervention

Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months. Classes for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.

Group II: English for Second Language InterventionActive Control1 Intervention

Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months. Children in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nutrition and Physical Activity Intervention

2019

N/A

~580

0 / 3Eligibility 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

Lifestyle modification programs for obesity focus on behavioral and educational interventions to promote sustainable weight loss. These programs aim to change dietary habits, increase physical activity, and improve coping skills. Behavioral interventions involve self-monitoring, goal setting, and problem-solving to help patients adhere to their weight loss plans. Educational interventions provide knowledge about nutrition and physical activity, empowering patients to make healthier choices. These approaches are crucial for obesity patients as they address the root causes of weight gain and help in achieving long-term health benefits.