Lifestyle Intervention for Obesity

Overseen By Michelle Ordonez Arango

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Mood stabilizers, Antipsychotics, Antidepressants

Disqualifiers: Diabetes, Cancer, Severe comorbidities, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 months

412 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the Vida Sana y Completa study is to provide evidence on the most effective approach for addressing the critical combination of obesity and food insecurity among Latinas in primary care while also collecting preliminary information on the potential for implementation and dissemination.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have recently changed your antidepressant medication, you must wait until your regimen is stable for at least 2 months before enrolling.

What data supports the effectiveness of the treatment Vida Sana, Vida Sana y Completa for obesity?

Research shows that lifestyle interventions, which include a combination of diet, exercise, and behavioral changes, can effectively help with weight loss and reduce obesity-related health risks. Programs that focus on increasing physical activity and promoting healthy eating habits have been found to improve health even without significant weight loss. ^{1 2 3 4 5}

Is the Vida Sana program safe for humans?

The Vida Sana program, implemented by the Chilean Ministry of Health, involves activities like psychologist consultations, lifestyle workshops, and physical activity sessions. While the studies focus on effectiveness, they do not report any safety concerns, suggesting it is generally safe for participants. ^{1 6 7 8 9}

What makes the Vida Sana y Completa treatment unique for obesity?

The Vida Sana y Completa treatment is unique because it focuses on a comprehensive lifestyle intervention, which includes coaching on physical activity, dietary behaviors, sleep, stress management, and behavioral change, rather than relying solely on medication or surgery. This approach aims to help individuals achieve and maintain a healthier lifestyle through both group and individual sessions. ^{10 11 12 13 14}

Research Team

Lisa Goldman Rosas, PhD, MPH

Principal Investigator

Stanford University

Wei-ting Chen, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for Latinas over 18 with obesity and food insecurity, having a BMI ≥30 kg/m2, high triglycerides or blood pressure, and other metabolic risks. Participants must be able to commit to the study for 24 months. Exclusions include recent antidepressant changes, lack of Spanish fluency, no reliable phone or internet access, plans to move away during the study period, certain medical conditions like severe comorbidities or active cancer within two years.

Inclusion Criteria

Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of 2 study arms, participate for 24 months, and authorize extraction of relevant information from the EHR.

Food insecurity: Defined as answering yes to one or both questions of the Hunger Vital Sign

My blood pressure is higher than 120/80 mmHg.

Exclusion Criteria

I have been diagnosed with bipolar or psychotic disorder in the last 2 years or am currently on medication for it.

Having no regular Internet access via a computer and/or mobile device (e.g., smartphone)

Investigator discretion for clinical safety or protocol adherence reasons

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Vida Sana or Vida Sana y Completa intervention, including 12 weekly group sessions, monthly phone sessions, and home visits. The Vida Sana y Completa group also receives weekly food box deliveries for the first 12 weeks.

12 months

12 weekly group sessions, 9 monthly phone sessions, 2 home visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with measurements taken at multiple time points.

12 months

In-person visits at 12 and 24 months

Treatment Details

Interventions

• Vida Sana
• Vida Sana y Completa

Trial Overview The Vida Sana y Completa study tests effective approaches for tackling obesity and food insecurity among Latina women in primary care settings. It compares two programs: 'Vida Sana' and 'Vida Sana y Completa', focusing on their potential impact on health outcomes and feasibility for broader implementation.

Participant Groups

Group I: Vida Sana y Completa Experimental Treatment 1 Intervention

Vida Sana y Completa is an obesity intervention with integrated treatment for food insecurity. This arm includes all the activities described for the active comparator arm (Vida Sana) as well as a weekly food box delivery for the first 12 weeks of the intervention. The food box will contain approximately 40 pounds of food including proteins and dairy, whole grains, and produce. Just like the Vida Sana active comparator arm, the Vida Sana y Completa group will include health coaches who will facilitate 12 weekly 1-hour group education sessions, followed by nine 30-45 minute individual monthly phone sessions. Health coaches will also conduct two home visits (at baseline and 12-weeks post-enrollment). The health coach will review participant's fitbit health tracking data with them and give personalized feedback.

Group II: Vida Sana Active Control 1 Intervention

Vida Sana is a cultural-adaption of Group Lifestyle Balance, a 12-month intervention that targets at least 5% weight loss and at least150 minutes per week of moderate-to-vigorous physical activity. Health coaches will facilitate 12 weekly 1-hour group education sessions, followed by nine 30-45 minute individual monthly phone sessions. Health coaches will also conduct two home visits (at baseline and 12-weeks post-enrollment). The health coach will review participant's fitbit health tracking data with them and give personalized feedback.

Vida Sana is already approved in United States for the following indications:

Approved in United States as Vida Sana for:

• Obesity prevention and management
• Diabetes prevention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

San Mateo Medical Center

Collaborator

Trials

4

Recruited

1,100+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

A lifestyle-modification program that includes increased physical activity and a balanced diet can significantly reduce obesity-related health risks, even if there is minimal or no weight loss.

Such lifestyle changes can lead to improvements in abdominal obesity, visceral fat, and cardiometabolic risk factors, as well as increases in muscle mass and cardiorespiratory fitness, highlighting the importance of focusing on health improvements rather than just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of obesity reduction: beyond weight loss. Ross, R., Bradshaw, AJ.[2021]

Obesity is rapidly increasing globally, particularly in developing countries, and is linked to serious health issues like type 2 diabetes and cardiovascular disease.

Lifestyle interventions, including diet, exercise, and psychological support, have a modest but significant impact on weight loss, with the best results seen when these methods are combined.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutics of lifestyle management on obesity. Dyson, PA.[2016]

In a study involving 116 patients over two years, educational measures and regular follow-ups significantly contributed to weight loss, with 5.1% achieving a weight reduction of at least 10%.

Patients who voluntarily discharged themselves showed the largest decrease in BMI (12.8), highlighting the importance of personal motivation in successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of educational intervention in obese patients]. Díaz Gómez, J., Armero Fuster, M., Calvo Viñuela, I., et al.[2013]

A six-month comprehensive care program for obesity in a public hospital in Mexico showed a 65% retention rate, with 40.1% of participants losing at least 5% of their starting weight, indicating the program's effectiveness.

Each additional visit to the program significantly increased the likelihood of achieving weight loss, with participants attending more than four visits showing the most benefit, highlighting the importance of consistent engagement in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Effectiveness of a Comprehensive Care Program for People Living with Obesity: A Real-World Experience in a Public Hospital in Mexico. Vázquez-Velázquez, V., García García, E.[2023]

A nurse-led interdisciplinary program focusing on healthy eating, exercise, and cognitive behavioral therapy resulted in significant weight loss (7.2 kg) and improvements in body mass index among 74 obese and overweight participants over 12 months.

Participants in the experimental group also experienced notable reductions in both systolic and diastolic blood pressure, indicating enhanced cardiovascular health, with these benefits maintained even one year after the program ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-medium-long-term efficacy of interdisciplinary intervention against overweight and obesity: Randomized controlled clinical trial. Fernández-Ruiz, VE., Armero-Barranco, D., Paniagua-Urbano, JA., et al.[2019]

The Vida Sana program was effective in promoting weight loss and improved physical fitness among overweight and obese women aged 20-44, with 32% achieving a 5% weight loss and 88% improving their physical fitness over 6 months.

Higher engagement in the program's core activities (psychologist consultations, lifestyle workshops, and physical activity sessions) significantly increased the likelihood of achieving the program's goals, with odds ratios showing that participation in more activities led to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The degree of engagement of overweight/obese adult women in the recommended activities of the Chilean "Vida Sana" program is directly correlated with its effectiveness. Mellado Peña, F., Mitchell, NS., Leyton Dinamarca, B., et al.[2022]

The Chilean 'Programa Vida Sana' (Healthy Life Program) significantly improved nutritional status and fitness in about 50% of participants aged 2-20 after a 6-month intervention, with the most notable improvements seen in younger children aged 2-5 years.

Participation in physical activity sessions and healthy life workshops was crucial for improving outcomes, especially for the youngest age group, while older participants showed less benefit from the program's activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the Chilean program "Vida Sana 2017" in participants under 20 years of age after 6 months of intervention]. Mellado Peña, F., Leyton Dinamarca, BL., Kain Berkovic, J.[2022]

The HRSA/MCHB/DHSPS funded 14 innovative programs across 12 states aimed at reducing obesity in women of childbearing age, utilizing evidence-based practices tailored to local communities.

Two successful programs, 'La Vida Sana, La Vida Feliz' in Illinois and 'Sisters in Action' in Michigan, demonstrated improved outcomes and are recognized as effective models for replication in other communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indicators of successful implementation of programs to promote healthy weight among women. Drayton, VL., Walker, DK., Mikolowsky, K.[2021]

The Coaching on Lifestyle programme (CooL) effectively helped adults achieve sustained improvements in motivation, lifestyle behaviors, quality of life, and weight over an 18-month period.

While adults showed significant positive changes, the program had mixed results for children and their parents, indicating that different strategies may be needed to engage younger participants effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. van Rinsum, C., Gerards, S., Rutten, G., et al.[2019]

A new questionnaire was developed to assess lifestyle behaviors related to obesity in the Spanish population, consisting of 22 items across five dimensions, including diet, physical activity, and alcohol intake, based on a study involving 335 overweight patients.

The questionnaire demonstrated high reliability and validity, making it an effective tool for evaluating lifestyle factors that contribute to obesity, with test-retest stability exceeding 0.90 for most dimensions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of a questionnaire for the assessment and quantification of overweight and obesity related lifestyles]. Pardo, A., Ruiz, M., Jódar, E., et al.[2019]

Lifestyle modifications for treating obesity are challenging to implement and sustain long-term, highlighting the need for effective strategies.

Simple and cost-effective interventions have shown potential benefits in specific populations, suggesting that targeted approaches may improve obesity treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lifestyle modification--a behavioral and educational challenge]. Tamir, O., Furmn-Assaf, S., Shemer, J.[2011]

The CooL intervention, a combined lifestyle program in the Netherlands, was found to be accessible and effective in helping obese individuals adopt healthier lifestyles, as evaluated by both participants and stakeholders.

Despite its positive reception, the program's success relies on increasing the recognition and integration of lifestyle coaches within the healthcare system, highlighting the need for better networking and communication about their role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of the coaching on lifestyle (CooL) intervention: lessons learnt. van Rinsum, C., Gerards, S., Rutten, G., et al.[2020]

A randomized clinical trial involving 445 participants showed that individual telephone counseling for obesity management significantly reduced weight regain compared to an email education control, with a posterior probability greater than 99%.

Participants receiving individual telephone counseling were more likely to achieve at least a 10% weight reduction (31.5%) compared to those in the control group (19.1%), indicating that personalized support can enhance long-term weight loss maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. Perri, MG., Shankar, MN., Daniels, MJ., et al.[2020]

A structured multidisciplinary non-surgical obesity therapy program led to significant weight loss over 52 weeks, with females losing an average of 19.6 kg and males 26.0 kg, demonstrating its effectiveness in treating obesity.

The program also resulted in a 50% reduction in the prevalence of metabolic syndrome and a decrease in hypertension rates from 47% to 29%, indicating substantial health benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of an interdisciplinary 52-week weight loss program for obesity with regard to body weight, comorbidities and quality of life--a prospective study. Bischoff, SC., Damms-Machado, A., Betz, C., et al.[2021]

References

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

The future of obesity reduction: beyond weight loss. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The therapeutics of lifestyle management on obesity. [2016]

3. Spain pubmed.ncbi.nlm.nih.gov

[Results of educational intervention in obese patients]. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Effectiveness of a Comprehensive Care Program for People Living with Obesity: A Real-World Experience in a Public Hospital in Mexico. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Short-medium-long-term efficacy of interdisciplinary intervention against overweight and obesity: Randomized controlled clinical trial. [2019]

6. Spain pubmed.ncbi.nlm.nih.gov

The degree of engagement of overweight/obese adult women in the recommended activities of the Chilean "Vida Sana" program is directly correlated with its effectiveness. [2022]

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

[Evaluation of the Chilean program "Vida Sana 2017" in participants under 20 years of age after 6 months of intervention]. [2022]

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

Indicators of successful implementation of programs to promote healthy weight among women. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. [2019]

10. Spain pubmed.ncbi.nlm.nih.gov

[Development of a questionnaire for the assessment and quantification of overweight and obesity related lifestyles]. [2019]

11. Israel pubmed.ncbi.nlm.nih.gov

[Lifestyle modification--a behavioral and educational challenge]. [2011]

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

The implementation of the coaching on lifestyle (CooL) intervention: lessons learnt. [2020]

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

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of an interdisciplinary 52-week weight loss program for obesity with regard to body weight, comorbidities and quality of life--a prospective study. [2021]