NCT01182701

Brief Summary

The proposed study is a two arm randomized controlled trial with longitudinal follow-up that compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs. Control) by Time (Pre, Post, Follow Up).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
Last Updated

August 17, 2010

Status Verified

August 1, 2010

Enrollment Period

5.5 years

First QC Date

August 6, 2010

Last Update Submit

August 13, 2010

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesAsian Pacific IslandersCognitive behavioral intervention

Outcome Measures

Primary Outcomes (4)

  • Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.

    Baseline

  • Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.

    Post (6 weeks)

  • Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.

    6 months

  • Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.

    1 year

Secondary Outcomes (4)

  • Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.

    Baseline

  • Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.

    Post (6 weeks)

  • Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.

    6 months

  • Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.

    1 year

Study Arms (2)

Behavioral intervention

ACTIVE COMPARATOR
Behavioral: Cognitive behavioral training

Education support

NO INTERVENTION

Interventions

Cognitive behavioral trainingBEHAVIORAL

The behavioral training group will be involved six group sessions focusing on cognitive behavioral training for stress and mood management, cognitive restructuring, empowerment, values clarification, problem solving and decision making via a manualized program

Behavioral intervention

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asian/Pacific Islander Men and Women with type 2 diabetes; asymptomatic for hyperglycemia
  • Both men and women will be included in the study if they have a diagnosis of type 2 diabetes made by a physician and meet classification and diagnostic criteria established by the American Diabetes Association (American Diabetes Association, 1997)
  • Between 18 and 76 years
  • Participation in diabetes education program of University Specialty Clinics

You may not qualify if:

  • Crippling arthritis
  • Joint replacements that limit movement
  • Neuromuscular disease with paralysis
  • Severe eye disease or visually impaired
  • Chronic renal failure and/or End Stage Renal Disease requiring hemodialysis or peritoneal dialysis
  • Transplant recipient
  • Foot Amputation
  • Congestive Heart Failure
  • New York Heart Class III/IV
  • Previous Cerebral Vascular Accident (stroke) with residual paralysis
  • Malignancy
  • Chronic hepatitis C
  • HIV disease
  • Individuals who contemplate changing residence within the period of study and becoming inaccessible to the study should be discouraged from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii School of Nursing & Dental Hygiene

Honolulu, Hawaii, 96822, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jillian Inouye, PhD, APRN

    Universtiy of Hawaii

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2010

First Posted

August 17, 2010

Study Start

August 1, 2004

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

August 17, 2010

Record last verified: 2010-08

Locations

US(1)