NCT00737347

Brief Summary

The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3 type-2-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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2008

Completed
Last Updated

August 19, 2008

Status Verified

August 1, 2008

Enrollment Period

3.5 years

First QC Date

August 15, 2008

Last Update Submit

August 18, 2008

Conditions

Type 2 DiabetesObesity

Keywords

type 2 diabetesobesityweight gainthiazolidinediones

Outcome Measures

Primary Outcomes (1)

  • change in body weight

    24 weeks

Secondary Outcomes (1)

  • change in body composition

    24 weeks

Study Arms (3)

1

NO INTERVENTION

usual care. Subjects had one 90 minute visit with registered dietitian

2.

ACTIVE COMPARATOR

Standard care. Subjects had 4 sessions with registered dietitian

Behavioral: Lifestyle modification

3

ACTIVE COMPARATOR

Intensive care. subjects had 10 visits with registered dietitian

Behavioral: Lifestyle modification

Interventions

Lifestyle modificationBEHAVIORAL

lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling

Also known as: lifestyle behavioral counseling
2.3

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater

You may not qualify if:

  • insulin treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital Wellness Institute

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityWeight Gain

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Robert F Kushner, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 19, 2008

Study Start

September 1, 2003

Primary Completion

March 1, 2007

Study Completion

April 1, 2008

Last Updated

August 19, 2008

Record last verified: 2008-08

Locations

US(1)