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

Trial Summary

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 data supports the effectiveness of the treatment What I Learned at Home in the clinical trial Fitness Program for Women's Health?

Research shows that exercise can significantly improve women's health by reducing the risk of heart disease, slowing bone loss, and boosting mood. Home-based exercise programs, especially those using audio-visual guidance, have been effective in improving health indicators and mental well-being in inactive women. ^{1 2 3 4 5}

Is the fitness program for women's health generally safe for humans?

The safety data for herbal supplements, which may be similar to the fitness program, shows that adverse events are reported but often underreported. Some herbs like oats, marijuana, and St John's Wort have been associated with adverse events, suggesting that while many supplements are safe, some can cause issues. It's important to monitor any reactions and report them to healthcare providers. ^{6 7 8 9 10}

How does the treatment 'What I Learned at Home' differ from other treatments for women's health?

The 'What I Learned at Home' treatment is unique because it focuses on a home-based, self-monitored exercise program that includes moderate-intensity activities like walking and housework, which are accessible and convenient for women. This approach contrasts with traditional supervised group exercise programs, making it more flexible and potentially more sustainable for long-term health benefits. ^{11 12 13 14 15}

What is the purpose of this trial?

This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population.

Research Team

Kim McCall, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prescribing exercise for women. [2021]

2. Singapore 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. [2022]

3. Germany 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Monitored home-based with or without face-to-face exercise for maternal mental health during the COVID-19 pandemic. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Exercise as Medicine for Older Women. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Adverse event reporting for herbal medicines: a result of market forces. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]

8. Japan pubmed.ncbi.nlm.nih.gov

[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. [2019]

9. Japan pubmed.ncbi.nlm.nih.gov

[Nationwide Online Survey Method to Estimate Ongoing Adverse Events Caused by Supplement Use: Application to Diarrhea]. [2021]

10. England 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The interaction between regular exercise and selected aspects of women's health. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

Exercise in the menopausal woman. [2009]

14. United States 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. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of self-monitored, home-based, moderate-intensity exercise training in middle-aged men and women. [2019]