NCT00770926

Brief Summary

This study aims to design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, in reducing risk of diabetes in persons at risk with a focus on reaching lower-income, minority individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable diabetes

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

Study Start

First participant enrolled

September 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

2.9 years

First QC Date

October 8, 2008

Last Update Submit

May 19, 2013

Conditions

Diabetes

Keywords

risk reductionminoritydiabetes preventionlifestyle programbehavior change

Outcome Measures

Primary Outcomes (1)

  • Body weight

    one year

Secondary Outcomes (1)

  • diet

    One year

Study Arms (2)

Program immediately

EXPERIMENTAL

Receives the lifestyle program as soon as possible after randomization

Behavioral: Live Well, Be Well

Wait list control

NO INTERVENTION

Wait one year and at the end of the year, is offered the option of participating in the program

Interventions

Live Well, Be WellBEHAVIORAL

Lifestyle change program using personal contact and telephone counseling

Program immediately

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 25 and older
  • moderate- to high-risk score on a Diabetes Risk Appraisal (DRA) (assessing sedentary behavior, family history of diabetes, race/ethnicity, gestational diabetes, hypertension, and high cholesterol) and a fasting fingerstick glucose level of 95-140 mg/dL (indicating high risk of diabetes).
  • conversant in English or Spanish

You may not qualify if:

  • diabetes, assessed by self-report of having ever been told by a physician that they have diabetes (other than gestational) OR use of an oral hypoglycemic medication or insulin, OR a fingerstick fasting glucose level of \>150 mg/dl;
  • unstable chronic or serious condition that could limit participation in unsupervised light to moderate physical activity (e.g. unstable angina, diagnosed with or hospitalized for chest pain, heart surgery, stroke, or myocardial infarction in the past 6 months);
  • uncontrolled hypertension (systolic \>180 mmHg or diastolic \>105 mmHg);
  • current pregnancy or attempting to conceive;
  • plans to move from the area within 1 year;
  • insufficient cognitive functioning to complete program procedures,
  • implanted defibrillator,
  • a hip or knee replacement in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (2)

  • Delgadillo AT, Grossman M, Santoyo-Olsson J, Gallegos-Jackson E, Kanaya AM, Stewart AL. Description of an academic community partnership lifestyle program for lower income minority adults at risk for diabetes. Diabetes Educ. 2010 Jul-Aug;36(4):640-50. doi: 10.1177/0145721710374368. Epub 2010 Jun 24.

    PMID: 20576836RESULT

  • Santoyo-Olsson J, Cabrera J, Freyre R, Grossman M, Alvarez N, Mathur D, Guerrero M, Delgadillo AT, Kanaya AM, Stewart AL. An innovative multiphased strategy to recruit underserved adults into a randomized trial of a community-based diabetes risk reduction program. Gerontologist. 2011 Jun;51 Suppl 1(Suppl 1):S82-93. doi: 10.1093/geront/gnr026.

    PMID: 21565823RESULT

MeSH Terms

Conditions

Diabetes MellitusRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Anita L Stewart, Ph.D

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 10, 2008

Study Start

September 1, 2006

Primary Completion

August 1, 2009

Study Completion

May 1, 2013

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations

US(1)