Fitness Program for Women's Health

(BEFIT Trial)

Overseen By Kimberly McCall, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Inability to understand instructions

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

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the factors contributing to a lack of physical activity among low-income African American women. It focuses on developing a fitness education program called BeFit, tailored to this community. The treatment under evaluation is "What I Learned at Home," a program designed to boost confidence in maintaining an active lifestyle. Suitable participants include mothers of school-aged children who live in HABD housing and are available during program hours. As an unphased trial, this study allows participants to contribute to developing a program that could significantly enhance community health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for participants?

Research shows that programs like "What I Learned at Home" are usually easy for people to manage. Although specific studies on this exact program are lacking, similar ones have helped people become more active without major safety issues. Since this trial focuses on a lifestyle program rather than a new drug, the risks are generally lower. Participants should mainly be cautious about common issues like overexertion, which can be avoided by following the program's advice. It is important to pay attention to how one feels and take breaks when needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "What I Learned at Home" program because it offers a fresh approach to women's health by focusing on self-efficacy and behavioral change. Unlike traditional fitness programs that often rely on structured classes or gym sessions, this intervention empowers women to implement health and fitness strategies within their own homes. This unique focus on home-based, personalized interventions could make it easier for women to integrate healthier habits into their daily lives, potentially leading to more sustainable long-term health improvements.

What evidence suggests that this program is effective for improving women's health?

Research shows that exercising at home can greatly improve health. One study found that both men and women lost weight and body fat through home exercise programs. Another study found that using an exercise app for 12 weeks helped reduce feelings of depression and burnout. These results suggest that planned exercise routines at home can boost both physical and mental well-being. This trial tests the "What I Learned at Home" program as a self-efficacy behavioral intervention, likely using these ideas to help people believe in their ability to succeed and to encourage long-term exercise habits. ^{6 7 8 9 10}

Who Is on the Research Team?

Kim McCall, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for low-income African American women who are mothers of school-aged children, at least 18 years old, living in HABD housing with stable arrangements for over a year and available during program hours. It's not suitable for those unable to understand study instructions.

Inclusion Criteria

I am a mother with a child in kindergarten through 12th grade.

Tenants of HABD in good standing with a minimum of one year of stable living arrangements

I am female.

Exclusion Criteria

Inability to understand study instructions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the BeFit physical activity education program

12 weeks

Follow-up

Participants are monitored for barriers to physical activity engagement

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• What I Learned at Home

Trial Overview

The 'BeFit Toolbox Collaboration' aims to tackle sedentarism by developing a physical activity education program called BeFit, specifically tailored for low-income African American women living in HABD communities.

How Is the Trial Designed?

Group I: What I Learned at Home Experimental Treatment 1 Intervention

What I Learned at Home is a self-efficacy behavioral intervention that will help provide the framework of implementation for the BeFIT program in the future. The BeFIT program will be a component of the WILAH framework.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A 12-week home-based exercise program using audio-visual guidance improved HDL cholesterol levels and mental well-being in 24 inactive premenopausal women, indicating potential benefits for cardiometabolic health.

The exercise intervention did not significantly change other health markers like LDL cholesterol, triglycerides, or body composition, suggesting that while the program is effective for certain health aspects, it may not impact all areas of cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a novel home-based exercise intervention on health indicators in inactive premenopausal women: a 12-week randomised controlled trial. Connolly, LJ., Scott, S., Morencos, CM., et al.[2020]

Regular exercise has protective health benefits and can prevent disease and functional decline in older women, yet many do not meet recommended activity levels.

Physicians can utilize exercise as a targeted tool in treatment plans, emphasizing the importance of physical fitness assessments to tailor interventions for improving health outcomes in older female patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as Medicine for Older Women. Lewis, CB., Laflin, M., Gray, DL.[2021]

The Canadian adverse event reporting system for herbal products is severely underreported, leading to a lack of safety data, which poses risks to consumers who often perceive these products as safe.

Health food store personnel in the Greater Toronto Area play a crucial role in reporting adverse reactions by collecting customer information during product returns, suggesting a potential pathway to improve safety monitoring and reporting for herbal products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting for herbal medicines: a result of market forces. Walji, R., Boon, H., Barnes, J., et al.[2021]

Regular recreational exercise is generally beneficial for women's reproductive health throughout their lives, with adverse effects only occurring when exercise levels significantly exceed typical recreational amounts.

The relationship between exercise and reproductive health is complex and influenced by hormonal status and various exercise factors, indicating that exercise regimens should be tailored to different life stages for optimal benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The interaction between regular exercise and selected aspects of women's health. Clapp, JF., Little, KD.[2019]

A 6-month self-monitored, home-based exercise program significantly improved maximal oxygen uptake (VO2 max) by 15% in men and 9% in women, indicating enhanced functional capacity for both genders.

While men experienced a notable decrease in body weight (1.5 kg), women did not show significant weight loss; however, adherence to the training program was higher in men, suggesting that consistent participation may influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of self-monitored, home-based, moderate-intensity exercise training in middle-aged men and women. Juneau, M., Rogers, F., De Santos, V., et al.[2019]

The study analyzed adverse event reports related to herbal supplements from two databases, FAERS and CVAR, revealing that herbal supplements accounted for 2.51% and 6.83% of total reports, respectively, indicating a significant presence of herbal-related safety concerns.

Common herbs associated with adverse events included Avena sativa (oats), Cannabis sativa (marijuana), and Hypericum perforatum (St John's Wort), highlighting the need for further investigation into the safety profiles of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. Sharma, V., Gelin, LFF., Sarkar, IN.[2020]

Regular physical activity significantly lowers the risk of serious health issues in women, such as coronary heart disease and certain cancers, highlighting its importance for overall health.

Despite the known benefits, many women in the U.S. do not engage in regular physical activity, prompting public health recommendations to include a wider range of activities like gardening and walking to encourage participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of recommended levels of physical activity among women--Behavioral Risk Factor Surveillance System, 1992. [2008]

A mobile video-guided home exercise program significantly improved exercise adherence (75.6% vs. 55.2%) and self-efficacy for exercise compared to a standard paper-based program in stroke recovery patients over three months.

Participants using the video-guided program also showed greater improvements in mobility levels (MFAC gain of 1.7 vs. 1.0) but did not demonstrate significant differences in basic activities of daily living (ADL) compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study on comparisons between the effectiveness of mobile video-guided and paper-based home exercise programs on improving exercise adherence, self-efficacy for exercise and functional outcomes of patients with stroke with 3-month follow-up: A single-blind randomized controlled trial. Chung, BPH., Chiang, WKH., Lau, H., et al.[2022]

This study will compare adherence and effects of a face-to-face plus monitored home exercise program against a monitored home-based exercise program in 150 pregnant women, assessing outcomes up to six months postpartum.

The research aims to demonstrate that these exercise programs can improve mental health and other maternal and neonatal outcomes, potentially offering a cost-effective alternative to traditional supervised exercise during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitored home-based with or without face-to-face exercise for maternal mental health during the COVID-19 pandemic. Veisy, A., Mohammad-Alizadeh-Charandabi, S., Abbas-Alizadeh, S., et al.[2023]

A 24-week self-monitored home-based exercise program for 54 middle-aged participants (28 men and 26 women) led to significant improvements in peak oxygen uptake, with increases of 13.7% in men and 10% in women, indicating enhanced cardiovascular fitness.

Participants generally exceeded their prescribed exercise intensity, achieving 108% of the caloric expenditure goal for men and 90% for women, with minimal musculoskeletal issues reported, suggesting that home-based exercise can be both effective and safe for middle-aged individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment by a microprocessor of adherence to home-based moderate-intensity exercise training in healthy, sedentary middle-aged men and women. Rogers, F., Juneau, M., Taylor, CB., et al.[2019]

An internet-based reporting system was developed to help healthcare professionals, particularly pharmacists, report dietary supplement-related adverse events, addressing the issue of underreporting due to lack of awareness and time constraints.

The system not only facilitated the collection of DS-related events but also provided educational resources, which increased engagement and awareness among healthcare professionals regarding the safety of dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. Asahina, Y., Hori, S., Sawada, Y.[2019]

A study involving 78,220 dietary supplement users found that 9% to 25% reported experiencing adverse events, with a focus on diarrhea as a common symptom.

Online surveys proved to be an effective method for identifying adverse events related to dietary supplements, particularly highlighting that herbal ingredients like Coleus forskohlii were frequently associated with diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nationwide Online Survey Method to Estimate Ongoing Adverse Events Caused by Supplement Use: Application to Diarrhea]. Nishijima, C., Chiba, T., Sato, Y., et al.[2021]

In a study involving 1118 patients across 10 community pharmacies, it was found that 58.8% of patients were using both prescription drugs and natural health products (NHPs) concurrently, which significantly increased their risk of experiencing adverse events (AEs).

Patients using both prescription drugs and NHPs were 6.4 times more likely to report an AE compared to those using only prescription drugs, highlighting the importance of monitoring concurrent use for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality. Necyk, C., Tsuyuki, RT., Boon, H., et al.[2022]

An exercise program combining aerobic and resistance training can help menopausal women prevent or alleviate health issues like cardiovascular disease, obesity, and osteoporosis, which are common during this life stage.

Regular aerobic exercise improves heart health and metabolic rate, while resistance training enhances muscle strength and bone density, making it a crucial part of a healthy lifestyle for menopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in the menopausal woman. Shangold, MM.[2009]

Many women in the U.S. do not meet the recommended levels of physical activity, which could significantly improve their health by reducing risks for cardiovascular disease and osteoporosis, and enhancing mood during pregnancy.

The article emphasizes the importance of tailored exercise prescriptions for women, providing guidance on how to create and adapt these prescriptions based on individual medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribing exercise for women. Senter, C., Appelle, N., Behera, SK.[2021]

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