← Back to Search

Lifestyle Intervention for Obesity

N/A

Recruiting

Led By Lisa Goldman Rosas, PhD, MPH

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Systolic blood pressure >120 mmHg or diastolic blood pressure >80 mmHg as measured by study coordinator

One or more metabolic risk factors as follows: Fasting plasma glucose of 100 to 125 mg/dL or HbA1c of 5.7 to 6.4 if detected by a recent (within the past year), documented, blood-based diagnostic test in the Electronic Health Record (EHR) in the last year

Must not have

Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication

Previous diagnosis of diabetes (other than during pregnancy) or diabetes documented in the EHR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months, 18 months, 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different approaches to help Latinas who are obese and food insecure. The hope is that this will provide evidence on the best way to help this population, and also help with implementing and spreading this information.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this trial focuses on lifestyle interventions rather than medications, side effects are not typical as seen with drugs but may include discomfort from dietary changes or increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My blood pressure is higher than 120/80 mmHg.

Select...

My blood sugar or HbA1c levels are slightly high.

Select...

My HDL cholesterol is low according to my recent health records.

Select...

I am 18 years old or older.

Select...

I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have been diagnosed with diabetes, not just during pregnancy.

Select...

I do not have severe illnesses like advanced kidney disease, serious heart failure, or liver failure.

Select...

I have had or am planning to have weight loss surgery.

Select...

I cannot speak, read, or understand Spanish.

Select...

I have a health condition that stops me from walking 1 mile.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, 12 months, 18 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, 12 months, 18 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months, 18 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight change (12 months)

Secondary study objectives

Bidimensional Acculturation Scale for Hispanics

COVID-19 Impact on Health and Wellbeing Survey for Health Literacy

Cardiometabolic risk factors

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vida Sana y CompletaExperimental Treatment1 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 SanaActive Control1 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.

0 / 11Eligibility criteria met