What side effects are associated with this type of intervention?

Lifestyle and behavioral interventions for obesity, such as those studied in the 'Healthy Dads Healthy Kids' trial, generally focus on diet modification, increased physical activity, and behavior therapy. These interventions are typically safe and do not have significant adverse effects. However, some individuals may experience temporary discomforts such as muscle soreness from increased physical activity or gastrointestinal changes from dietary adjustments. Overall, these interventions are considered beneficial and are associated with minimal risk.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including semaglutide and liraglutide, which have shown significant weight loss benefits when combined with lifestyle interventions. In the STEP trials, semaglutide demonstrated substantial weight loss in patients with obesity, especially when paired with lifestyle changes such as diet and exercise. Similarly, liraglutide has been effective in improving glycemic control and promoting weight loss in pediatric patients with type 2 diabetes when used alongside metformin and lifestyle modifications. These treatments align with the principles of the Healthy Dads Healthy Kids program, which emphasizes family-focused lifestyle and behavioral changes to combat obesity.

What other types of research exist?

Promising alternatives to the HDHK program for obesity treatment in 2024 include: 1) The Go4it multidisciplinary group treatment, which combines cognitive behavioral therapy with education on healthy dietary and physical activity behaviors. 2) Family-based lifestyle interventions like the TODAY study, which integrates intensive lifestyle changes with pharmacotherapy for better glycemic control in youth with type 2 diabetes. 3) Emerging pharmacological treatments such as GLP-1 receptor agonists (e.g., liraglutide) and SGLT2 inhibitors, which have shown efficacy in managing obesity and related metabolic conditions. 4) Surgical options like sleeve gastrectomy and Roux-en-Y gastric bypass, which have demonstrated significant weight loss and improvement in comorbidities in adolescents with severe obesity.

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Healthy Lifestyle Program for Obesity Prevention in Hispanic Families (HDHK Trial)

N/A

Recruiting

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Age 18-65 years old

BMI >/= 25 - 40

Must not have

Child not within the 5-11 year old age range

Father with known diagnosis of diabetes without medical clearance from health care provider

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program where Hispanic fathers and their children learn about healthy eating and exercise together. It targets overweight or obese Hispanic men who are father figures to children aged 5-11. The program aims to help families support each other in making healthier lifestyle choices.

Who is the study for?

This trial is for Hispanic fathers or male role models (18-65 years old) and their children (5-11 years old), living in the Greater Houston Area, with a BMI between 25 and 40. They must be able to read/write in Spanish or English and pass a health screener. Exclusions include those with certain medical conditions like uncontrolled diabetes, cardiovascular disease without clearance, plans to move away soon, extreme BMI values, or current participation in other weight management programs.

What is being tested?

'Healthy Dads Healthy Kids' program is being tested against standard care control for obesity prevention among Hispanic families. The program targets fathers as primary participants to improve both their own and their children's health outcomes by promoting physical activity and healthy dietary intake.

What are the potential side effects?

Since this trial involves lifestyle interventions such as diet changes and increased physical activity rather than medication, side effects may include muscle soreness from new exercise routines, potential dietary adjustment issues like changes in bowel habits or food cravings; however these are generally mild.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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My BMI is between 25 and 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child is not between 5 and 11 years old.

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My father has diabetes and hasn't been cleared by a doctor.

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My father had heart inflammation due to COVID or its vaccine.

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My father's BMI is either below 25 or above 40.

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My child has been diagnosed with diabetes.

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My child has been diagnosed with a heart condition.

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My father has been diagnosed with heart disease.

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My father's HbA1c level is 6.5% or higher without doctor's approval.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 12 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

Child´s moderate to vigorous physical activity (MVPA)

Secondary study objectives

Child's BMI z-score

Child's and father's sedentary time

Child´s MVPA

+11 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

Group I: Standard of care controlExperimental Treatment1 Intervention

National guidelines and recommendations for healthy eating, physical activity and weight loss.

Group II: Healthy Dads Healthy KidsExperimental Treatment1 Intervention

A group-based lifestyle behavioral program for Hispanic fathers and children

0 / 10Eligibility 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

The most common treatments for obesity, particularly those involving lifestyle and behavioral changes, include dietary modifications, increased physical activity, and behavioral therapy. Dietary modifications focus on reducing caloric intake and improving nutritional quality, which helps in creating a calorie deficit necessary for weight loss. Increased physical activity boosts energy expenditure, aiding in weight reduction and improving cardiovascular health. Behavioral therapy addresses the psychological aspects of eating and activity habits, helping patients develop sustainable, healthy behaviors. These treatments are crucial for obesity patients as they not only promote weight loss but also improve overall health, reduce the risk of obesity-related conditions, and enhance quality of life.

Pharmacotherapy in Childhood Obesity.Weight loss in children and adolescents.