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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02459691
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
University of Illinois at Chicago
University of Pittsburgh
RTI International
University of California, Santa Cruz
Information provided by (Responsible Party):
Jun Ma, MD, PhD, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Prediabetic State Metabolic Syndrome X Insulin Resistance Behavioral: Vida Sana Other: Usual Care Only Not Applicable

Detailed Description:

This study has two phases: Phase 1: Formative research and Phase 2: Randomized Controlled Trial (RCT). The purpose of the formative research phase 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). The purpose of the RCT is to rigorously evaluate the effectiveness and implementation potential of the CAI program.

The proposed intervention will uniquely adapt the coach-led, technology-supported Group Lifestyle Balance (GLB) program that the investigators proved effective in the investigators' prior trial called E-LITE, to provide culturally and linguistically appropriate lifestyle intervention for weight loss and increased physical activity among high-risk Latinos in primary care. The CAI will be delivered in small groups as well as using existing, rapidly expanding internet and mobile technologies (Website, email, and mobile text messaging). Once developed the investigators will subject the CAI to rigorous evaluation in an RCT of 186 eligible and consenting Latinos. The investigators hypothesize that CAI participants will achieve a greater mean reduction in body mass index (BMI) from baseline to 24 months (primary outcome) than usual care controls. Secondary outcomes will include measures of cardiometabolic risk factors (e.g., lower fasting glucose and lipid levels), psychosocial well-being (e.g., improved mood), and behavior change (e.g., increased physical activity). The overarching research goal is to determine the effectiveness and implementation potential of the CAI based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos in Primary Care (E-LITE Latinos)
Actual Study Start Date : September 2014
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual Care Only
Patients assigned to this group will continue medical care as usual.
Other: Usual Care Only
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.

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




Primary Outcome Measures :
  1. Change in weight from baseline [ Time Frame: 12- and 24-months ]
    Change in weight


Secondary Outcome Measures :
  1. Change in composite measure of cardiometabolic risk factors [ Time Frame: Baseline, 12- and 24-months ]
    Blood pressure, waist circumference, waist-to-height ratio

  2. Change in Body Mass Index from Baseline [ Time Frame: 12- and 24-months ]
    BMI

  3. Clinically significant weight loss [ Time Frame: 12 and 24 months ]
    5% or greater weight loss



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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
    • Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg
    • Fasting plasma glucose of 100 to 125 mg/dL
  • Primary Care Physician approval of patient contact for study screening
  • 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 two study arms, participate in follow-up for 24 months, and authorize extraction of relevant information from the Electronic Health Record.

Exclusion criteria:

  • Medical exclusions:
  • 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
  • Other exclusions:
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459691


Sponsors and Collaborators
Palo Alto Medical Foundation
Agency for Healthcare Research and Quality (AHRQ)
University of Illinois at Chicago
University of Pittsburgh
RTI International
University of California, Santa Cruz
Investigators
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Principal Investigator: Jun Ma, MD, PhD UIC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jun Ma, MD, PhD, Beth and George Vitoux Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02459691    
Other Study ID Numbers: 14-10-365
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Keywords provided by Jun Ma, MD, PhD, University of Illinois at Chicago:
prediabetes
metabolic syndrome
lifestyle
behavior change
primary care
latinos
diet
physical activity
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Prediabetic State
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases