Healthy Lifestyle Program for Heart Disease Risk Reduction

(MBC2 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nancy Schoenberg

Must not be taking: Weight loss medication

Disqualifiers: Unstable medical conditions, Cognitive impairment, Psychiatric hospitalization, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests the MBC2 program, which uses an app, fitness tracker, health coaching, and rewards to improve diet and exercise habits. It targets adults in rural Appalachia, Kentucky who have poor health profiles. The program helps participants track their habits, get personalized advice, and earn rewards for meeting health goals.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it does exclude those taking weight loss medication.

What data supports the effectiveness of the treatment Adapted MBC2 Program, Stress Management Control for heart disease risk reduction?

Research shows that lifestyle programs focusing on diet, exercise, stress management, and social support can significantly improve heart health. These programs have been effective in reducing risk factors like blood pressure and cholesterol, and improving quality of life in people with heart disease. ^{1 2 3 4 5}

Is the Healthy Lifestyle Program for Heart Disease Risk Reduction safe for humans?

In a study involving a lifestyle modification program with dietary supplements, no adverse events related to the diet or supplements were reported, indicating it was generally safe for participants. ^{6 7 8 9 10}

How is the Adapted MBC2 Program treatment different from other treatments for heart disease risk reduction?

The Adapted MBC2 Program is unique because it focuses on a comprehensive lifestyle modification approach, which includes multiple components like physical exercise, healthy eating habits, and psychological support to improve adherence and reduce heart disease risk factors, unlike standard treatments that may focus solely on medication or single lifestyle changes. ^{4 11 12 13 14}

Research Team

Eligibility Criteria

This trial is for adults living in Appalachian Kentucky who want to improve their health habits. Participants should be willing to use a smartphone app and wear an accelerometer, spend over 90 minutes daily on recreational screen time, eat less than 4.5 cups of fruits/vegetables daily, engage in less than 150 minutes of physical activity weekly, and consume more than 8% of their calories from saturated fat.

Inclusion Criteria

Willingness to use smart phone to record and modify diet and activity

Engages in less than 150 minutes of moderate-intensity physical activity weekly

I am willing to wear a movement tracking device.

Exclusion Criteria

I use devices to help me move around.

Unstable medical conditions

I have difficulty with memory or thinking clearly.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the adapted MBC2 or stress management program, utilizing a smartphone app, accelerometers, telephone coaching, and behavioral incentives to improve diet and physical activity or manage stress.

9 months

Monthly virtual check-ins

Follow-up

Participants are monitored for changes in diet, activity, and health-related outcomes after the intervention period.

3 months

Treatment Details

Interventions

• Adapted MBC2 Program (Behavioural Intervention)
• Stress Management Control (Behavioural Intervention)

Trial Overview The study tests the 'Adapted MBC2 Program' which includes an app, accelerometer tracking, health coaching sessions, and incentives aimed at increasing fruit/vegetable intake and physical activity while reducing saturated fat consumption and sedentary screen time among participants.

Participant Groups

Group I: Adapted MBC2 Group Experimental Treatment 1 Intervention

The Adapted MBC2 Program will utilize a smart phone app, accelerometers, telephone coaching, and behavioral incentives to target fruit and vegetable intake, dietary fat intake, physical activity, and high sedentary leisure screen time. Participants will wear accelerometers, log hours slept, enter real-time information about their relaxation exercises and stress, and monitor goal thermometers to meet targets.

Group II: Stress Management Group Active Control 1 Intervention

The Stress Management Program will utilize a smart phone app, accelerometers, telephone coaching, and behavioral incentives to target stress, relaxation, and sleep. Participants will wear accelerometers, log hours slept, enter real-time information about their relaxation exercises and stress, and monitor 3 goal thermometers (sleep, relaxation, stress) to meet behavioral targets. The Stress Management Program, including the use of the app and assessments, is identical to the Adapted MBC2 program, with the exception of the content.

Who Is Running the Clinical Trial?

Nancy Schoenberg

Lead Sponsor

Trials

5

Recruited

3,900+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

A systematic review of 40 trials involving 35,548 participants found that Mediterranean dietary programmes significantly reduce all-cause mortality, cardiovascular mortality, stroke, and non-fatal myocardial infarction compared to minimal interventions, indicating their efficacy in patients at increased cardiovascular risk.

Low fat dietary programmes also showed effectiveness in reducing all-cause mortality and non-fatal myocardial infarction, but there were no significant differences in outcomes between Mediterranean and low fat diets, suggesting both are beneficial for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of seven popular structured dietary programmes and risk of mortality and major cardiovascular events in patients at increased cardiovascular risk: systematic review and network meta-analysis. Karam, G., Agarwal, A., Sadeghirad, B., et al.[2023]

A study of 440 patients with coronary artery disease showed that a multi-component lifestyle change program significantly improved diet, exercise, stress management, and overall health outcomes over 12 months, benefiting both men and women equally.

The program is particularly advantageous for women, who typically face higher risks of mortality and morbidity from heart-related issues, suggesting it could help address gender disparities in heart disease outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in medical risk factors and quality of life in women and men with coronary artery disease in the Multicenter Lifestyle Demonstration Project. Koertge, J., Weidner, G., Elliott-Eller, M., et al.[2022]

A 6-month structured lifestyle intervention for patients with cardiovascular disease (CVD) significantly improved physical activity and reduced body mass index (BMI) and waist circumference, indicating its effectiveness in enhancing cardiovascular risk profiles.

Despite patients receiving optimal usual care and cardioprotective drug treatment, the lifestyle intervention provided additional benefits, highlighting the importance of lifestyle modifications alongside medication in managing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial. Ijzelenberg, W., Hellemans, IM., van Tulder, MW., et al.[2021]

In an observational study of 722 coronary heart disease patients across 36 practices in Spain, community-oriented programs aimed at promoting healthy lifestyles did not show significant added value in cardiovascular risk management outcomes compared to practices without such programs.

While practices that implemented community programs had higher rates of patients receiving antihypertensives, antiplatelet therapy, and statins, these differences were not statistically significant, suggesting that these programs may not enhance the effectiveness of cardiovascular risk management for CHD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community programmes for coronary heart disease in Spanish primary care. Frigola-Capell, E., van Lieshout, J., Muñoz, MA., et al.[2017]

In a study of 72 participants in a lifestyle modification program, those with elevated cardiovascular disease (CVD) risk factors but no clinical disease showed equal or greater improvements in heart health compared to those with existing CVD.

The results indicate that intensive lifestyle change programs can be effective for primary prevention of CVD, highlighting their importance for individuals at increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. Ellsworth, DL., O'Dowd, SC., Salami, B., et al.[2019]

In a study of 89 pre-obese and obese postmenopausal women, higher adherence to the Mediterranean diet was associated with improved cardiovascular risk profiles, including lower levels of total cholesterol, VLDL-cholesterol, and triglycerides.

The findings suggest that following the Mediterranean diet can be an effective strategy for reducing cardiovascular disease risk in postmenopausal women, particularly those who are pre-obese or obese.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to a Mediterranean diet and cardio-metabolic risk in postmenopausal women by body composition. Atalay, BG., Akkuş, ÖÖ., Yapıcı, Y.[2022]

In a study of 101 hypertensive patients, a group educational strategy aimed at lifestyle changes showed a greater decline in cardiovascular risk in the intervention group compared to the control group, although the differences were not statistically significant.

Both groups experienced improvements in blood pressure and physical exercise levels, but the intervention group did not show significant changes in BMI or calorie intake compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of an educational intervention group on changes in lifestyles in hypertensive patients in primary care: a randomized clinical trial]. Rodríguez Martín, C., Castaño Sánchez, C., García Ortiz, L., et al.[2019]

In a 13-week study involving 44 healthy overweight subjects with cardio-metabolic syndrome risk factors, a lifestyle modification program combined with targeted nutraceutical supplementation (PROG) led to significant improvements in body mass, fat mass, and various cholesterol levels compared to a diet-only group (DIET).

The PROG group also saw a 40% reduction in the Framingham 10-year cardiovascular disease risk score, indicating enhanced cardiovascular health benefits from the combination of lifestyle changes and nutraceuticals, with no reported adverse events related to the interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 13-week low glycemic load diet and lifestyle modification program combining low glycemic load protein shakes and targeted nutraceuticals improved weight loss and cardio-metabolic risk factors. Dahlberg, CJ., Ou, JJ., Babish, JG., et al.[2018]

In a study of 123 patients with moderate to severe coronary artery disease, those who adhered closely to a healthy lifestyle program showed significant regression of coronary atherosclerosis, with an average reduction in percent diameter stenosis of 18.23%.

Patients with high adherence to the program experienced significantly fewer cardiac events over a follow-up period of 6.5 years, highlighting the importance of maintaining over 50% adherence to achieve meaningful health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regression of coronary atherosclerosis through healthy lifestyle in coronary artery disease patients--Mount Abu Open Heart Trial. Gupta, SK., Sawhney, RC., Rai, L., et al.[2019]

A lifestyle intervention involving individual counseling for male construction workers significantly reduced body weight over 12 months, indicating its effectiveness in managing obesity-related risks for cardiovascular disease.

The intervention also led to improvements in diastolic blood pressure and favorable changes in HDL cholesterol and HbA1c levels, highlighting its potential benefits for overall cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained body weight reduction by an individual-based lifestyle intervention for workers in the construction industry at risk for cardiovascular disease: results of a randomized controlled trial. Groeneveld, IF., Proper, KI., van der Beek, AJ., et al.[2022]

A 2-year lifestyle behavior program significantly improved lifestyle habits such as diet, exercise, and smoking cessation in patients who underwent angioplasty, leading to a lower hospitalization rate (4% vs 20%) in the intervention group during the second year.

Despite improvements in lifestyle behaviors, the program did not significantly affect serum cholesterol levels, body mass index, or quality of life compared to the control group, indicating that while behavior change is beneficial, it may not always translate to changes in all health risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year results of a controlled study of residential rehabilitation for patients treated with percutaneous transluminal coronary angioplasty. A randomized study of a multifactorial programme. Hofman-Bang, C., Lisspers, J., Nordlander, R., et al.[2022]

In a study of 127 participants with metabolic syndrome, adherence to a lifestyle modification program was influenced by factors such as age, physical exercise, and self-efficacy regarding eating habits.

Key predictors of adherence included being older, regularly exercising, having confidence in maintaining healthy eating, and lower scores for binge eating and feelings of isolation or depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of adherence in a prevention program for patients with metabolic syndrome. Susin, N., de Melo Boff, R., Ludwig, MW., et al.[2018]

In a study of 6477 male workers over 9 years, maintaining a good overall lifestyle significantly improved recovery from cardiovascular disease risk factors, especially for those with a single risk factor.

For individuals with multiple risk factors, non-smoking and limiting working hours were particularly effective in aiding recovery, although the overall impact of lifestyle changes was less pronounced compared to those with a single risk factor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of lifestyle on multiple risk factors in male workers. Koetaka, H., Ohno, Y., Morimoto, K.[2021]

The Isfahan Healthy Heart Program (IHHP) significantly reduced cardiometabolic risk factors such as abdominal obesity, hypertension, and hypercholesterolemia in a population of 2,180,000 people over a period from 2000-2001 to 2007.

The program was particularly effective in decreasing hypercholesterolemia among females (from 23.5% to 12.5%) and males (from 18.5% to 9.6%), demonstrating the efficacy of a community-based approach to health promotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a comprehensive healthy lifestyle program on cardiometabolic risk factors in a developing country: the Isfahan Healthy Heart Program. Sarrafzadegan, N., Kelishadi, R., Sadri, G., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of seven popular structured dietary programmes and risk of mortality and major cardiovascular events in patients at increased cardiovascular risk: systematic review and network meta-analysis. [2023]

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

Improvement in medical risk factors and quality of life in women and men with coronary artery disease in the Multicenter Lifestyle Demonstration Project. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial. [2021]

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

Community programmes for coronary heart disease in Spanish primary care. [2017]

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

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. [2019]

6. China pubmed.ncbi.nlm.nih.gov

Adherence to a Mediterranean diet and cardio-metabolic risk in postmenopausal women by body composition. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

[Efficacy of an educational intervention group on changes in lifestyles in hypertensive patients in primary care: a randomized clinical trial]. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

A 13-week low glycemic load diet and lifestyle modification program combining low glycemic load protein shakes and targeted nutraceuticals improved weight loss and cardio-metabolic risk factors. [2018]

9. India pubmed.ncbi.nlm.nih.gov

Regression of coronary atherosclerosis through healthy lifestyle in coronary artery disease patients--Mount Abu Open Heart Trial. [2019]

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

Sustained body weight reduction by an individual-based lifestyle intervention for workers in the construction industry at risk for cardiovascular disease: results of a randomized controlled trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Two-year results of a controlled study of residential rehabilitation for patients treated with percutaneous transluminal coronary angioplasty. A randomized study of a multifactorial programme. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Predictors of adherence in a prevention program for patients with metabolic syndrome. [2018]

13. Japan pubmed.ncbi.nlm.nih.gov

Long-term effects of lifestyle on multiple risk factors in male workers. [2021]

14. Iran pubmed.ncbi.nlm.nih.gov

Outcomes of a comprehensive healthy lifestyle program on cardiometabolic risk factors in a developing country: the Isfahan Healthy Heart Program. [2022]