NCT00656682

Brief Summary

The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
509

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

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

April 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 29, 2018

Status Verified

August 1, 2014

Enrollment Period

5.3 years

First QC Date

April 10, 2008

Last Update Submit

March 27, 2018

Conditions

HyperglycemiaObesityDiabetes Mellitus

Keywords

Prevention & ControlHyperglycemiaObesityDiabetes MellitusCost Benefit Analysis

Outcome Measures

Primary Outcomes (1)

  • % Change in Body Weight

    (weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)

    12 months

Secondary Outcomes (9)

  • % Change in Blood Total Cholesterol

    12 months

  • % Change in glycosylated hemoglobin

    12 months

  • % Change in Blood Pressures

    12 months

  • Changes in Dietary Composition

    12 months

  • Changes in Physical Activity

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Dietitian Counseling Alone

ACTIVE COMPARATOR

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone

Behavioral: Dietitian Counseling Alone

Dietitian Plus Community Group Lifestyle

EXPERIMENTAL

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based diabetes prevention lifestyle intervention offered by the community. Dietitian Counseling Plus Community Group Lifestyle Intervention.

Behavioral: Dietitian Plus Community Group Lifestyle

Interventions

Dietitian Counseling AloneBEHAVIORAL

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian

Dietitian Counseling Alone
Dietitian Plus Community Group LifestyleBEHAVIORAL

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes

Dietitian Plus Community Group Lifestyle

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Body-mass index of 24 kg/m2 or greater
  • Fasting Blood Glucose 100 - 125 mg/dl, OR 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl

You may not qualify if:

  • Cancer requiring treatment in the past 5 years
  • Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg
  • Heart attack, stroke, or transient ischemic attack in the past 6 months,
  • Chronic obstructive airways disease or asthma requiring home oxygen
  • Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to \<5 years
  • Pregnancy
  • Existing diagnosis of diabetes mellitus
  • Fasting capillary blood glucose \> 125 mg/dl
  • hour post-challenge capillary blood glucose \> 199 mg/dl
  • History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes
  • Self-report of a medication known to lead to hyperglycemia (oral steroids, antipsychotics, anti-epileptics)
  • Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

HyperglycemiaObesityDiabetes Mellitus

Interventions

Nutritionists

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Ronald T Ackermann, MD, MPH

    Northwestern University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Dean for Public Health Director, Institute for Public Health and Medicine, Professor of Medicine

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 11, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 29, 2018

Record last verified: 2014-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)