Physical Activity for Heart Disease and Obesity Prevention

(AFL Trial)

Overseen By Bianca Vargas-Tequida, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Noe Crespo

Disqualifiers: Medical condition contraindicated to exercise

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

290 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase physical activity and fitness among Latino families in San Diego, California, and Mexicali, Baja California. It seeks to address high rates of heart disease and obesity by offering physical activity programs, particularly for children and their families. Participants will either join a 12-month intervention program that includes sports skills and nutrition education or continue with regular activities at community centers. Families with children aged 6-11 who live near the targeted community centers may be a good fit. As an unphased trial, this study provides families with a unique opportunity to actively improve their health and well-being through community-based programs.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing physical activity and fitness, so it's best to consult with the trial organizers or your doctor for guidance.

What prior data suggests that this physical activity program is safe for children and their families?

Research has shown that physical activity is generally safe and offers many health benefits. Studies indicate that regular exercise can lower the risk of heart disease and improve overall health, particularly in preventing conditions like obesity and heart disease.

Aerobic exercises, such as walking or cycling, typically do not increase the risk of serious side effects, even for individuals with heart conditions. Moderate-intensity exercise, performed regularly, is both safe and effective. This involves activities that raise the heart rate but still allow comfortable conversation.

Most people can handle these activities well. Engaging in regular physical activity is a proven way to boost fitness and health without significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how structured physical activity can prevent heart disease and obesity, potentially offering a proactive approach to these conditions. Unlike standard treatments that often involve medication or surgery, this method focuses on gradually increasing physical activity and sports skills in families. It emphasizes social support and education, which could lead to sustainable lifestyle changes. By teaching both children and parents advanced skills and nutrition knowledge, the program aims to empower families to maintain an active lifestyle and prevent health issues long-term.

What evidence suggests that physical activity is effective for heart disease and obesity prevention?

This trial will compare a Physical Activity Intervention Program with a Control Group. Research has shown that regular physical activity effectively prevents heart disease and obesity. Those who exercise regularly have a 20% to 30% lower risk of dying compared to those who don't exercise enough. Regular exercise can reduce the risk of heart disease by 27%, making it a strong method for maintaining heart health. It also helps prevent weight gain, which is crucial for avoiding obesity-related problems. Overall, staying active is essential for a healthier life and can help prevent many long-term health issues. ^{1 3 4 6 7}

Who Is on the Research Team?

Noe C Crespo, MS, MPH, PhD

Principal Investigator

San Diego State University

Daniela G Gonzalez-Valencia, PhD

Principal Investigator

Universidad Autonoma de Baja California

Are You a Good Fit for This Trial?

This trial is for underserved Latino families living near the U.S.-Mexico border, specifically in San Diego and Mexicali. It aims to help those at risk of heart disease and obesity by encouraging physical activity. Families interested in participating must be willing to engage with community center programs.

Inclusion Criteria

I am a parent and I am 18 years old or older.

My child is between 6 and 11 years old.

Living in the target community (within 5 miles of one of the targeted community centers)

Exclusion Criteria

Presence of a medical or physical condition that is contraindicated to participating in sports/exercise (e.g., negative score on the Physical Activity Readiness Questionnaire (PAR-Q))

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Program - Beginner Phase

Focus on introductory concepts and basic sports skills, establishing consistent behavioral patterns and social support

3 months

Monthly family Olympics events

Intervention Program - Intermediate Phase

Introduce more complex nutrition and behavioral concepts, increase difficulty of sport skills, and reinforce behavioral patterns

3 months

Monthly family Olympics events

Intervention Program - Advanced Phase

Teach advanced sports skills and nutrition knowledge, preparing participants to become team leaders

3 months

Monthly family Olympics events

Sustainability Phase

Assessments at organizational and individual levels to evaluate the sustainability of the intervention

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity

Trial Overview

The intervention being tested is a program designed to promote physical activity among Latino families. The study will work through local community centers, aiming to improve fitness levels and reduce the risk of cardiovascular diseases and obesity.

How Is the Trial Designed?

Group I: Intervention Program Experimental Treatment 1 Intervention

The 12-month intervention will progressively increase in intensity \& complexity to teach parents/children more complex sports skills \& behavioral techniques, \& to prepare them to become future team leaders for nutrition education and sports sessions. In addition, the family Olympics events will take place after every 3-month to reinforce progression, social support, \& progressive improvements: Phase 1: Beginner (months 0-3) will focus on introductory concepts \& basic sports skills \& will focus on establishing consistent behavioral patterns \& social support. Phase 2: Intermediate (months 4-6) will begin to introduce slightly more complex nutrition \& behavioral concepts, increase difficulty of sport skills, \& reinforce behavioral patterns from phase 1. Phase 4: Advanced (months 10-12) will teach parents \& children advanced sports skills \& nutrition knowledge so that they may become team leaders to help implement future activity sessions and nutrition education sessions.

Group II: Control Group Active Control 1 Intervention

Centers that are randomly assigned to the control group will continue with regularly schedule programing and activities. Families recruited from control centers will be allowed to take part in all the programs offered at the recreation centers, with exception to the AFL program since it will not be offered at those centers. Control group families will also receive publicly available information regarding the benefits of PA and strategies to become physically active (e.g., CDC PA guidelines websites \& handbook). 12-month sustainability phase will involve assessments at the organizational and individual levels. At the organizational level, we will examine the number of AFL sessions held at each recreation center and document the number of phone consultations, length of calls, and barriers addressed. At the individual level, we will examine the number of minutes of adult and child habitual PA.

Who Is Running the Clinical Trial?

Noe Crespo

Lead Sponsor

Trials

1

Recruited

290+

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Universidad Autonoma de Baja California

Collaborator

Trials

22

Recruited

2,500+

Published Research Related to This Trial

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A study involving 242 patients who underwent percutaneous coronary intervention showed that those receiving a positive-affect/self-affirmation (PA) intervention were significantly more likely to increase their physical activity by at least 336 kcal/week after 12 months compared to a standard patient education group (54.9% vs 37.4%).

The PA intervention group not only had a higher percentage of patients meeting the activity goal but also demonstrated nearly double the improvement in weekly kilocalorie expenditure (602 kcal vs 328 kcal), indicating that this behavioral intervention effectively promotes sustained physical activity post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of positive-affect induction to promote physical activity after percutaneous coronary intervention. Peterson, JC., Charlson, ME., Hoffman, Z., et al.[2021]

Exercise has numerous benefits for individuals with obesity, including aiding in weight loss and improving cardiovascular health, but the direct impact on weight loss from exercise alone is modest, typically resulting in only a few kilograms of weight loss.

Physical activity is crucial for managing type 2 diabetes and preventing its complications, and a structured approach like the 5 A's strategy can help healthcare professionals effectively support patients in overcoming barriers to increasing their physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. Oppert, JM., Bellicha, A., Ciangura, C.[2021]

Regular exercise significantly increases markers of exercise capacity, such as VO2max and ventilatory threshold (VT), which can enhance overall quality of life, especially for patients with health limitations.

Exercise serves as a positive health recommendation that not only improves physical fitness but may also indirectly encourage patients to adopt healthier behaviors, contrasting with traditional negative health advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training prescriptions for patients. Foster, C., Cadwell, K., Crenshaw, B., et al.[2019]

Regular exercise significantly benefits patients with heart disease by improving exercise tolerance, controlling risk factors, and potentially influencing the progression of coronary artery disease.

Patients should follow physician-guided exercise plans that include dynamic endurance activities and moderate-intensity circuit weight training, with a recommended duration of 2 to 3 hours per week, while high-risk patients should exercise at lower intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. Niederhauser, HU.[2008]

Exercise is crucial for managing heart disease, and patients should undergo careful screening to create a safe and effective exercise prescription based on their test results.

Moderate-intensity exercise or exercising under medical supervision is recommended for safety, and these programs have been proven to enhance both the quality and quantity of life for heart disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for the cardiac patient. Long-term maintenance phase. Hartley, LH.[2017]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

Citations

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