Physical Activity for Heart Disease and Obesity Prevention

(AFL Trial)

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

Trial Summary

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 data supports the effectiveness of the treatment Physical Activity, Exercise, Physical Exercise, Physical Activity Intervention for heart disease and obesity prevention?

Research shows that physical activity and exercise can help with weight loss, improve cardiovascular risk, and enhance exercise capacity, which is linked to better quality of life. Additionally, exercise can positively influence heart disease by increasing exercise tolerance, controlling risk factors, and potentially affecting the progression of coronary artery disease. ^{1 2 3 4 5}

Is physical activity generally safe for humans?

Physical activity is generally safe for humans, with few serious adverse events reported. Minor issues, like muscle or joint injuries, can occur, especially in sedentary or older individuals, but starting slowly and gradually increasing intensity can help minimize these risks. ^{6 7 8 9 10}

How does physical activity as a treatment for heart disease and obesity prevention differ from other treatments?

Physical activity is unique because it is a natural, non-drug approach that helps prevent heart disease and obesity by improving physical and mental health, controlling weight, and reducing body fat. Unlike medications, it involves regular exercise, which can be tailored to individual needs and integrated into daily life. ^{11 12 13 14 15}

What is the purpose of this trial?

This study has the goal to increase physical activity and fitness among Latinos in San Diego, California and Mexicali, Baja California (U.S.-Mexico border) since these cities have similar diseases such as high rates of heart disease and obesity. Therefore there is a need to have physical activity programs for children and their families. We will collaborate with community centers to have this program available.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Collaborator

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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Physical activity in management of persons with obesity. [2021]

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Physical activity and exercise training prescriptions for patients. [2019]

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Cardiac rehabilitation for patients with obesity: lessons learned from the OPTICARE XL trial. [2023]

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

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[Heart patient and sports]. [2008]

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Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

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Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

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Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

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A randomized controlled trial of positive-affect induction to promote physical activity after percutaneous coronary intervention. [2021]

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