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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized pilot research trial studies how well Eat, Move, Live (EML) works in reducing chronic disease risk in medically vulnerable communities. Obesity, unhealthy diet, and physical inactivity are linked to increased cancer risk, especially hormone-related cancer (example, breast cancer). Improving healthy lifestyle practices, namely increasing physical activity and encouraging healthy eating behaviors may reduce the risk of getting cancer and chronic disease.

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.

Is the Lifestyle Program for Reducing Chronic Disease Risk safe for humans?

The studies reviewed show that lifestyle programs focusing on diet and physical activity, like the ones mentioned, are generally safe for humans. Participants in these programs reported positive satisfaction and improvements in health measures such as blood pressure and cholesterol levels, with no significant safety concerns noted. ^{1 2 3 4 5}

How is the Eat, Move, Live (EML) treatment different from other treatments for reducing chronic disease risk?

The Eat, Move, Live (EML) treatment is unique because it combines dietary changes and physical activity to reduce chronic disease risk, similar to the SLIMMER and CHIP programs, but it may offer a more integrated approach to lifestyle modification. Unlike standard medical treatments, EML focuses on sustainable lifestyle changes rather than medication. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Eat, Move, Live (EML) in the Lifestyle Program for Reducing Chronic Disease Risk?

Research shows that lifestyle programs combining diet and physical activity, like the EML treatment, can significantly improve health outcomes. For example, a study found that a similar program led to better physical activity, diet, and health markers, such as lower blood pressure, in rural communities. ^{1 3 4 10 11}

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. England pubmed.ncbi.nlm.nih.gov

Effect and maintenance of the SLIMMER diabetes prevention lifestyle intervention in Dutch primary healthcare: a randomised controlled trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lifestyle Modification Program Delivered under Real-World Conditions in a Rural Setting. [2021]

3. United States 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. [2019]

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

Intensive weight loss intervention in older individuals: results from the Action for Health in Diabetes Type 2 diabetes mellitus trial. [2022]

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

Effects of diet and lifestyle changes on atherosclerotic risk factors after 24 weeks on the Indian Diet Heart Study. [2019]

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

One-year outcomes of an intense workplace cardio-metabolic risk reduction program among high-risk employees: The My Unlimited Potential. [2022]

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

Achieving weight and activity goals among diabetes prevention program lifestyle participants. [2022]

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

The Complete Health Improvement Program (CHIP) and reduction of chronic disease risk factors in Canada. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Exercise and diet in weight management: updating what works. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Weight loss and incidence of diabetes with the Veterans Health Administration MOVE! lifestyle change programme: an observational study. [2022]

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

Kaiser Permanente's Community Health Initiative in Northern California: evaluation findings and lessons learned. [2019]