NCT00007800

Brief Summary

This clinical trial examines whether the addition of individual sessions of a motivational intervention to a state-of-the art behavioral group weight loss intervention for overweight women with Type 2 diabetes improves the weight losses and glycemic control outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started May 2000

Typical duration for phase_2 diabetes-mellitus-type-2

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

May 1, 2000

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

January 5, 2001

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

First QC Date

January 5, 2001

Last Update Submit

January 12, 2010

Conditions

Diabetes Mellitus, Type 2Obesity

Keywords

obesity treatmentnon insulin dependent diabetestype 2 diabetesbehavioral weight controlmotivational interviewingmotivational enhancement

Interventions

Behavioral Group Weight Loss InterventionBEHAVIORAL
Motivational InterviewingBEHAVIORAL

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index of 27 - 50
  • Type 2 diabetes currently treated with oral medications
  • Ability to walk for exercise

You may not qualify if:

  • Use of insulin
  • Current pregnancy
  • Presence of debilitating disease, psychotic condition or any other condition that might interfere with participation
  • Failure to complete self monitoring diary for 1 week
  • Plans to move out of the area in the upcoming 18 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 5, 2001

First Posted

January 5, 2001

Study Start

May 1, 2000

Study Completion

May 1, 2002

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

US(1)