Clinical trial NCT02459691: Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos)
Official title: Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos in Primary Care (E-LITE Latinos)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Metabolic Syndrome X
Insulin Resistance
Keywords: prediabetes
metabolic syndrome
lifestyle
behavior change
primary care
latinos
diet
physical activity
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: University of Illinois at Chicago
name: University of Pittsburgh
name: RTI International
name: University of California Santa Cruz
First posted: 2015-06-02
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in weight from baseline
timeFrame: 12- and 24-months
Secondary outcomes:
measure: Change in composite measure of cardiometabolic risk factors
timeFrame: Baseline, 12- and 24-months
measure: Change in Body Mass Index from Baseline
timeFrame: 12- and 24-months
measure: Clinically significant weight loss
timeFrame: 12 and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: UIC
name: Jun Ma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.