Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos)

NCT02459691 | Completed DMC

• 1 other identifier: 14-10-365
• Study Type: interventional
• Target: 191
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to develop a culturally adapted intervention (CAI) program to improve weight and physical activity in overweight or obese adult Latinos at high risk for developing type 2 diabetes and/or cardiovascular disease (CVD) and to rigorously evaluate the effectiveness and implementation potential of the CAI program.

Conditions

Prediabetic State; Metabolic Syndrome X; Insulin Resistance

Keywords

prediabetes; metabolic syndrome; lifestyle; behavior change; primary care; latinos; diet; physical activity

Outcome Measures

Primary Outcomes (1)

• Change in weight from baseline

  Change in weight

  12- and 24-months

Secondary Outcomes (3)

• Change in composite measure of cardiometabolic risk factors

  Baseline, 12- and 24-months

• Change in Body Mass Index from Baseline

  12- and 24-months

• Clinically significant weight loss

  12 and 24 months

Study Arms (2)

Usual Care Only

ACTIVE COMPARATOR

Patients assigned to this group will continue medical care as usual.

Other: Usual Care Only

Vida Sana

EXPERIMENTAL

Patients assigned to this group will continue medical care as usual and in addition will receive the culturally adapted intervention.

Behavioral: Vida Sana

Interventions

Vida Sana BEHAVIORAL

Vida Sana is a Diabetes Prevention Program-based, culturally-adapted intervention that will have 2 distinct stages: The intensive treatment stage will implement a culturally adapted year-long Group Lifestyle Balance curriculum. The curriculum uses a goal-based approach to promote positive outcome expectancies and foster self-efficacy. The maintenance stage will be focused on (1) facilitating continued behavior change; (2) fostering participants' self-efficacy and independence; and (3) reinforcing problem-solving and behavior maintenance skills. These will be done via secure e-messaging.

Vida Sana

Usual Care Only OTHER

Patients assigned to this group will continue medical care as usual. That is, they will continue to see their primary care provider and any specialist he/she may recommend. They may also access additional health education resources available at the Palo Alto Medical Foundation. They will continue to receive general age and gender-appropriate reminders of health maintenance tests/exams and immunizations, per Palo Alto Medical Foundation standard practice.

Usual Care Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age(as of date of enrollment):
• Lower age limit: 18 years
• Upper age limit: NONE (only exclude for cause, e.g. disease and functional limitations, as detailed below)
• Race/ethnicity: Mexican Latino of any race
• Gender: men and women
• Body mass index: ≥24 kg/m2 (≥22 kg/m2 if of Asian descent)
• Having pre-diabetes, metabolic syndrome, or both based on the following criteria:
• Pre-diabetes according to any one of the following criteria:
• 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 or by a fasting blood test during study screening
• Plasma glucose measured 2 hours after a 75 gm glucose load of 140 to 199 mg/dl if detected by a recent (within the past year), documented, blood-based diagnostic test (Oral glucose tolerance test will not be performed for study screening considering participant burden)
• Clinically diagnosed gestational diabetes mellitus during a previous pregnancy (may be self-reported)
• Metabolic syndrome according to 3 or more of the following:
• Waist circumference ≥40 inches in men and ≥35 inches in women (≥35 inches in men and ≥31 inches in women, if of Asian descent)
• Triglycerides \>150 mg/dL
• High-density lipoprotein cholesterol (HDL-C) \<40 mg/dL in men and \<50 mg/dL in women

You may not qualify if:

• Previous diagnosis of diabetes (other than during pregnancy) or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
• Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years;
• Serious medical condition anticipated to prevent person from walking 1 mile (e.g., severe pulmonary disease or aortic stenosis)
• Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
• Diagnosis of a terminal illness and/or in hospice care;
• Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
• Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
• Have had or plan to undergo bariatric surgery during the study period
• Inability to speak, read or understand Spanish or English
• Having no reliable telephone service
• Having no regular Internet access via a computer and/or mobile device (e.g., smart-phone)
• Currently pregnant or lactating or planning to become pregnant during the study period
• Plan to move out of the area during the study period
• Family/household member of another study participant or of a study staff member
• Investigator discretion for clinical safety or protocol adherence reasons

Sponsors & Collaborators

• Palo Alto Medical Foundation: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• University of Illinois at Chicago: collaborator
• University of Pittsburgh: collaborator
• RTI International: collaborator
• University of California Santa Cruz: collaborator

Related Publications (2)

• Rosas LG, Lv N, Xiao L, Lewis MA, Venditti EMJ, Zavella P, Azar K, Ma J. Effect of a Culturally Adapted Behavioral Intervention for Latino Adults on Weight Loss Over 2 Years: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2027744. doi: 10.1001/jamanetworkopen.2020.27744.

  PMID: 33337491 DERIVED

• Rosas LG, Lv N, Xiao L, Lewis MA, Zavella P, Kramer MK, Luna V, Ma J. Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): A randomized controlled trial. Contemp Clin Trials. 2016 May;48:30-40. doi: 10.1016/j.cct.2016.03.003. Epub 2016 Mar 16.

  PMID: 26995280 DERIVED

MeSH Terms

Conditions

Prediabetic State; Metabolic Syndrome; Insulin Resistance; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Behavior

Study Officials

• Jun Ma, MD, PhD

  UIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beth and George Vitoux Professor of Medicine

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 2, 2015
• Study Start: September 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03