NCT00739336

Brief Summary

This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). The main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. The investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable type-2-diabetes-mellitus

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

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2016

Completed
Last Updated

October 5, 2016

Status Verified

August 1, 2016

Enrollment Period

6.4 years

First QC Date

August 19, 2008

Results QC Date

June 1, 2015

Last Update Submit

August 11, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes mellitusobesityprevention

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    Weight loss in kg

    3 months

Secondary Outcomes (5)

  • Fasting Glucose Level

    Baseline

  • Fasting Lipid Profile

    Baseline

  • Hemoglobin A1c

    baseline

  • Waist Circumference

    baseline, 3, 6, 12 months

  • Questionnaires

    baseline, 3, 6, 12 months

Study Arms (2)

A, 1

EXPERIMENTAL

Intervention: Immediate 3 month program

Behavioral: Diabetes Prevention and Control

A, 2

NO INTERVENTION

Wait-List Control

Interventions

Diabetes Prevention and ControlBEHAVIORAL

The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings.

A, 1

Eligibility Criteria

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

You may qualify if:

  • Adult employees of Onondaga County

You may not qualify if:

  • Not an employee of Onondaga County
  • Less than age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (1)

  • Barham K, West S, Trief P, Morrow C, Wade M, Weinstock RS. Diabetes prevention and control in the workplace: a pilot project for county employees. J Public Health Manag Pract. 2011 May-Jun;17(3):233-41. doi: 10.1097/PHH.0b013e3181fd4cf6.

    PMID: 21464685BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Trials Officer
Organization
SUNY Upstate Medical University
Rudesj@upstate.edu
315-464-5476

Study Officials

  • Ruth S Weinstock, MD, PhD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Service Professor

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 5, 2016

Results First Posted

October 5, 2016

Record last verified: 2016-08

Locations

US(1)