The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01626053

Acronym

ASMART

Enrollment

182

Registered

2012-06-22

Start date

2009-03-31

Completion date

2011-06-30

Last updated

2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

psychological, intervention, stages of change, motivational interviewing, coping skills, HbA1C, psychological testing, integrated care, behavioral health

Brief summary

It is hypothesized for this study that the coupling of the Millon Behavioral Medicine Diagnostic, biopsychosocial evaluation, motivational interviewing, relapse prevention, and ongoing support can produce improved outcomes with diabetics who have previously been unsuccessful with the traditional care. This study examined the relationship between patients' HbA1c levels and patients' involvement in the ASMART program, a multifaceted program involving psychological intervention. The study was conducted through the Kosciusko Health Department and funded by K21 Health Foundation.

Detailed description

The study involved 182 Type 2 Diabetes patients with an HbA1c score above 7, reflecting poor control of diabetes. The experimental group consisted of 124 patients who joined the ASMART program, while the control group consisted of 60 patients who continued to receive traditional care. Statistical analysis involved comparing pretest & posttest HbA1c levels for the experimental group and the control group.

Interventions

BEHAVIORALASMART

Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions

OTHERControl Group

no intervention

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 Diabetes patients with an HbA1c score over 7

Exclusion criteria

* No Type 1 patients * No children under the age of 18

Design outcomes

Primary

Measure	Time frame	Description
Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years	Pretest / posttest	Statistical analysis involved comparing pretest and psttest HbA1c levels for the experimental group and the control group

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026