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Prediabetic StateNCT02459691

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

A study testing Vida Sana in people with Prediabetic State and Metabolic Syndrome X, run by Palo Alto Medical Foundation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vida Sana
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
No sites listed yet
Study dates
Sep 2014to May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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;
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  • 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

About this study

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

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.

Read the 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.

Being tested
Vida Sana, Usual Care Only
Keywords
prediabetes, metabolic syndrome, lifestyle, behavior change, primary care, latinos, diet, physical activity
Medical subject headings
Prediabetic State, Metabolic Syndrome, Insulin Resistance, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vida SanaBehavioural

    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.

  • Usual Care OnlyOther

    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.

Study groups in NCT02459691
Study groupRoleWhat they receive
Usual Care OnlyActive comparatorPatients assigned to this group will continue medical care as usual.
Receives: Other: Usual Care Only
Vida SanaExperimentalPatients assigned to this group will continue medical care as usual and in addition will receive the culturally adapted intervention.
Receives: Behavioral: Vida Sana

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weight from baseline

    Change in weight

    Measured: 12- and 24-months

Secondary outcomes (3)

  1. Change in composite measure of cardiometabolic risk factors

    Blood pressure, waist circumference, waist-to-height ratio

    Measured: Baseline, 12- and 24-months

  2. Change in Body Mass Index from Baseline

    BMI

    Measured: 12- and 24-months

  3. Clinically significant weight loss

    5% or greater weight loss

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionMay 2019
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02459691
Sponsor's protocol ID
14-10-365
Status last verified
Mar 2020
First submitted
29 May 2015
Last updated
10 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33337491

  • 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.

    PubMed 26995280

Questions about this trial

What is this clinical trial studying?

A study testing Vida Sana in people with Prediabetic State and Metabolic Syndrome X, run by Palo Alto Medical Foundation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight from baseline (time frame: 12- and 24-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02459691, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.

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