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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459691
• Other study ID #: 14-10-365
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: May 2019

Study information

• Verified date: March 2020
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Prediabetic State

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation	Agency for Healthcare Research and Quality (AHRQ), RTI International, University of California, Santa Cruz, University of Illinois at Chicago, University of Pittsburgh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight from baseline	Change in weight	12- and 24-months
Secondary	Change in composite measure of cardiometabolic risk factors	Blood pressure, waist circumference, waist-to-height ratio	Baseline, 12- and 24-months
Secondary	Change in Body Mass Index from Baseline	BMI	12- and 24-months
Secondary	Clinically significant weight loss	5% or greater weight loss	12 and 24 months