NCT00842426

Brief Summary

The purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of two lifestyle interventions in a community based primary care setting. The study aims to assess how changes in diet, exercise, and behavioral self-management affect weight and related risk factors for adults at risk for diabetes and cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Jun 2009

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

September 13, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

February 11, 2009

Last Update Submit

September 11, 2012

Conditions

ObesityPre-diabetesMetabolic Syndrome

Keywords

DiabetesCardiovascular diseaseMetabolic syndromeCardiometabolic

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    Baseline, 3-, 6- and 15- month follow-up

Secondary Outcomes (6)

  • Metabolic syndrome criterion factors: waist circumference, BP, FBG, TG, HDL, TG/HDL

    Baseline, 6-, and 15-months

  • A1C, C-reactive protein

    Baseline and 15-months

  • Dietary Intake

    Baseline, 3-, 6-, and 15-months

  • Physical Activity

    Baseline, 3-, 6-, and 15-months

  • Generic and Obesity-specific Health Related Quality of Life

    Baseline, 3-, 6-, and 15-months

  • +1 more secondary outcomes

Study Arms (3)

Usual Care

NO INTERVENTION

Usual Care

Self-Management Program

EXPERIMENTAL

Online Self-Management.

Behavioral: Self-management program (SM)

Care Management Program

EXPERIMENTAL

Care management lifestyle modification program with intensive intervention phase with exercise and nutrition specialist. Followed by a online self-management phase.

Behavioral: Care management program (CM)

Interventions

Self-management program (SM)BEHAVIORAL

Participants will attend a group orientation where the study nutritionist will provide an overview of the self-management lifestyle intervention program. Participants will receive instructions on how to use HeartHubTM, the American Heart Association's patient portal for information, tools, resources about cardiovascular risk assessment, goal setting, action planning, and self-monitoring. During the remainder of the 15-month intervention, participants will receive reminders on a regular basis to use the patient portal to assist in their ongoing self-management.

Also known as: Self-monitoring and online tracking
Self-Management Program
Care management program (CM)BEHAVIORAL

In addition to participating in the activities described above, with the exception of the orientation session, participants in the Care Management Program will attend 12 weekly weight management classes during the initial 3 months. Classes will be co-led by a dietician and exercise specialist and will include a private weigh-in, a group discussion, a presentation of a lifestyle topic, 30 minutes of supervised moderate physical activity, followed by individual action-planning and goal-setting. During the remainder of the 15-month intervention, participants will continue to monitor their body weight, caloric intake, physical activity, and other data according to their care plan. In addition, study interventionist will follow up with participants regularly, via secure messaging or by phone, to provide ongoing counseling and support.

Also known as: Intensive Lifestyle Program
Care Management Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ethnicity: All ethnic groups;
  • Body mass index 25.0-39.9 kg/m2;
  • Fasting plasma glucose between 100 and 125 mg/dL;
  • Any two of the following: Waist circumference \>40 inches in men, \>35 inches in women (if in Asian American ≥ 35 inches in men; ≥31 inches in women); Triglycerides \>150 mg/dL; High-density lipoprotein cholesterol (HDL-C) \<40 mg/dL in men, \<50 mg/dL in women; Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>85 mm Hg.
  • Having a primary care physician (PCP) at the PAMF Los Altos Center;
  • Seen in primary or specialty care in the Palo Alto Region at least once in the preceding 24 months;
  • A PAMF patient for ≥ 12 months;
  • Able and willing to enroll and meet the requirements of the study.

You may not qualify if:

  • Inability to speak, read or understand English;
  • No regular access to a computer with Internet and email capabilities;
  • Triglycerides \>400 mg/dL;
  • Systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg;
  • Initiation or change of drug therapy for elevated blood pressure or abnormal lipid levels within the past 3 months
  • Having a medical (e.g., celiac disease) or social condition (e.g., religious beliefs) that precludes dietary changes;
  • Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe;
  • Use of weight-loss medications in the past 3 months;
  • Regular use (\> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.);
  • Currently enrolled in a lifestyle intervention program at PAMF or elsewhere;
  • Planning to undergo a bariatric surgery during the study period;
  • Diagnosis of Type 1 or Type 2 diabetes mellitus;
  • Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), heart disease, stroke, and ongoing substance abuse;
  • Renal insufficiency (i.e., GFR \< 60 mL/min/1.73m2)
  • Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto Medical Foundation, Los Altos Center

Palo Alto, California, 94022, United States

Location

Related Publications (5)

  • Xiao L, Lv N, Rosas LG, Au D, Ma J. Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials. Obesity (Silver Spring). 2017 Feb;25(2):363-369. doi: 10.1002/oby.21737. Epub 2017 Jan 6.

    PMID: 28059466DERIVED

  • Azar KM, Xiao L, Ma J. Baseline obesity status modifies effectiveness of adapted diabetes prevention program lifestyle interventions for weight management in primary care. Biomed Res Int. 2013;2013:191209. doi: 10.1155/2013/191209. Epub 2013 Dec 4.

    PMID: 24369008DERIVED

  • Ma J, Yank V, Xiao L, Lavori PW, Wilson SR, Rosas LG, Stafford RS. Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. JAMA Intern Med. 2013 Jan 28;173(2):113-21. doi: 10.1001/2013.jamainternmed.987.

    PMID: 23229846DERIVED

  • Yank V, Stafford RS, Rosas LG, Ma J. Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: a structured report of real-world applicability. Contemp Clin Trials. 2013 Jan;34(1):126-35. doi: 10.1016/j.cct.2012.10.007. Epub 2012 Oct 31.

    PMID: 23124047DERIVED

  • Ma J, King AC, Wilson SR, Xiao L, Stafford RS. Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial. BMC Fam Pract. 2009 Nov 12;10:71. doi: 10.1186/1471-2296-10-71.

    PMID: 19909549DERIVED

MeSH Terms

Conditions

ObesityGlucose IntoleranceMetabolic SyndromeDiabetes MellitusCardiovascular Diseases

Interventions

Self-Management

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesInsulin ResistanceHyperinsulinismEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jun Ma, M.D., Ph.D.

    Palo Alto Medical Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Investigator

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

September 13, 2012

Record last verified: 2012-09

Locations

US(1)