Lifestyle Program for Reducing Chronic Disease Risk

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Diabetes, Physical limitations, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Eat, Move, Live (EML) to determine its effectiveness in reducing the risk of chronic diseases, such as cancer, in potentially vulnerable communities. The program aims to improve lifestyle habits by promoting healthier eating and increased physical activity. Participants will attend engaging sessions on nutrition, exercise, and cooking, and participate in activities like salsa and Zumba. The trial seeks Latina mothers or female guardians of elementary school children who do not meet current guidelines for fruit and vegetable consumption or exercise. As an unphased trial, this study offers a unique opportunity to enhance personal health and contribute to community wellness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on lifestyle changes like diet and exercise.

What prior data suggests that the Eat, Move, Live (EML) program is safe for reducing chronic disease risk?

Research has shown that the Eat, Move, Live (EML) program helps people develop healthier lifestyle habits by emphasizing better eating and increased physical activity. Unlike traditional medical treatments or drugs, this program encourages healthier daily choices.

Studies have not reported any negative side effects from the EML program, indicating it is well-tolerated. Participants in similar programs have experienced benefits like weight loss, which can reduce the risk of chronic diseases, including some cancers. The program includes activities such as salsa and Zumba, along with nutrition advice, which are generally safe for most people.

Overall, based on current research, EML appears safe. It focuses on changing daily habits rather than using medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Program for Reducing Chronic Disease Risk because it offers a comprehensive and culturally tailored approach to health and wellness. Unlike standard treatments that might focus on medication or isolated lifestyle advice, this program combines interactive education on nutrition, practical cooking demonstrations, and community-focused exercise classes like salsa and Zumba. The program's emphasis on cultural responsiveness and community engagement aims to make healthy lifestyle changes more accessible and sustainable, potentially leading to more effective and lasting reductions in chronic disease risk.

What evidence suggests that the Eat, Move, Live (EML) program is effective in reducing chronic disease risk?

Research shows that lifestyle changes, such as those in the Eat, Move, Live (EML) program provided in this trial, can lower the risk of long-term diseases. Studies have found that programs like EML help people achieve healthier weights, reduce blood pressure, and improve blood sugar levels. Over 60% of participants in similar programs reported losing 5% of their weight or experiencing other health benefits. These improvements can decrease cancer risk, particularly in communities facing higher risks due to obesity and lack of physical activity. EML emphasizes teaching healthy eating and regular exercise, proven methods to enhance overall health. ^{1 2 4 6 7}

Who Is on the Research Team?

Kimlin Ashing-Giwa

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for Latina mothers or female guardians of elementary students who don't eat more than five servings of fruits and vegetables daily, nor exercise for 150 minutes a week. They must not have diabetes, consume a healthy diet, be physically active already, or have conditions that limit daily activities.

Inclusion Criteria

Not adherent to the standard for > five servings of fruits and vegetable and 150 minutes of physical activity

Self identify as Latina

I am a mother or female guardian of a child in elementary school.

Exclusion Criteria

I cannot engage in physical activities due to my condition.

Has a condition or psychological difficulties that affects day-to-day activities

Consumes 5+ servings of fruits and vegetables and is active for at least 30 minutes 5+ days per week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend interactive education sessions and participate in exercise classes over 12 weeks

12 weeks

2 weekday sessions, 3 exercise classes per week

Control

Participants receive a fitness tracker and are waitlisted for the intervention

10-12 months

Follow-up

Participants are monitored for changes in exercise levels, dietary habits, and metabolic markers

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Eat, Move, Live (EML)

Trial Overview The Eat, Move, Live (EML) program aims to reduce chronic disease risk by promoting physical activity and healthier eating habits through educational sessions, dietary guidance, exercise plans, and questionnaires to track progress.

How Is the Trial Designed?

Group I: Group I (EML) Experimental Treatment 5 Interventions

Participants complete an assessment on knowledge, attitudes, and behaviors at baseline and attend 2 weekday sessions comprised of interactive education segment that is culturally responsive, and based on the community EML program, and topics including: nutrition guideline, nutrition label reading, comparison shopping/grocery store tour, recipe modification and healthy food preparation, eating healthy on a budget, and making healthy choices outside the home (e.g., restaurants) and physical activity over 1 hour led by CHE, a physical activity conducted by Duarte Fitness Centers instructors over 30 minutes, and cooking/taste test demonstration co-led by the CHE and local chef over 30 minutes over 12 weeks. Participants are also prescribed and encouraged to participate in 3 days a week exercise classes (for \> 30 minutes) including salsa, Zumba and other aerobic exercises that are provided at Duarte Fitness Center.

Group II: Group II (control) Active Control 4 Interventions

Participants receive a fitness tracker to track their physical activity and be wait listed to receive the intervention during month 10-12.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A 12-month study involving 147 obese patients with type 2 diabetes showed that a lifestyle intervention program led by dietitians resulted in significantly greater weight loss (3.0 kg) and reduced waist circumference (-4.2 cm) compared to usual care.

Participants in the lifestyle case management group also experienced improved HbA1c levels, reduced use of diabetes medications by 0.8 medications per day, and enhanced health-related quality of life across multiple domains, indicating the program's effectiveness in managing diabetes and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Wolf, AM., Conaway, MR., Crowther, JQ., et al.[2019]

In the Diabetes Prevention Program, 49% of participants achieved their initial weight loss goal, and 74% met their physical activity goal, but long-term success dropped to 37% for weight loss and 67% for activity after about 3.2 years.

Older participants were more likely to achieve long-term weight loss and activity goals, and those who practiced dietary self-monitoring had better success in both areas, indicating that initial success in these goals is a strong predictor of long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving weight and activity goals among diabetes prevention program lifestyle participants. Wing, RR., Hamman, RF., Bray, GA., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02513407

Eat, Move, Live Intervention in Reducing Chronic Disease ... This randomized pilot research trial studies how well Eat, Move, Live (EML) works in reducing chronic disease risk in medically vulnerable communities.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05414396

Eat, Move, Live Program for the Reduction of Cancer and ... This clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy ...

3. mdpi.com mdpi.com/2673-4540/6/5/42

Plan, Track, and Live Mindfully: Insights from the Eat Smart ... Program data must demonstrate that at least 60% of program completers achieved any of the following outcomes at the conclusion of the program: a 5% weight loss, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12298808/

Impact of a Web-Based Lifestyle Medicine Intervention Lifestyle medicine interventions are cost-effective and have been shown to improve health behaviors, reverse disease progression, and reduce ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9021650/

Effect of a 1-Year Controlled Lifestyle Intervention on Body ... Lifestyle interventions have been shown to improve disease risk markers, including body weight, body mass index (BMI), blood pressure, fasting blood glucose, ...

6. aacrjournals.org aacrjournals.org/cebp/article/29/6_Supplement_1/B095/230945/Abstract-B095-Eat-Move-Live-An-intervention

Abstract B095: Eat, Move, Live: An intervention strategy for the ... This has important implications because weight loss has been linked to a reduction in the risk for cancer and other chronic diseases (1).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1829349/

Eat Better & Move More: A Community-Based Program ... This easy-to-implement program improves diets and activity levels. Local providers should offer more such programs with the goal of enabling older Americans.