NCT02668328

Brief Summary

The proposed study is an integrative scientific undertaking, reflecting the input of experts in the behavioral sciences, mHealth technology, computational biology, endocrinology, biochemistry, and nutrition. The project features a unique translational approach, connecting behavior and biology in an economical manner that provides mechanistic insights into the progression of type 2 diabetes (T2D) and the biologic consequences of behavior change. The project may have profound implications for the clinical management of early T2D.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

December 22, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

1.4 years

First QC Date

December 22, 2015

Last Update Submit

October 18, 2016

Conditions

Diabetes Mellitus Type 2 in Obese

Outcome Measures

Primary Outcomes (1)

  • Mean Amplitude of Glycemic Excursion (MAGE)

    1 week

Study Arms (1)

Behavioral Intervention

EXPERIMENTAL

The proposed study involves a 2-phase randomized clinical trial in adults with recently diagnosed T2D. Participants will be randomized to a wait-list Control group, BI, or Tailored-BI. In Phase 1, wait-list Control participants will receive 6 months of standard care; BI and Tailored-BI participants will receive 6 months of Active Intervention. In Phase 2, wait-list Control group participants will cross-over to the delayed Tailored-BI, and the BI and Tailored-BI participants will enter a 6-month observation phase to examine maintenance effects of the intervention.

Behavioral: Social Cognitive Theory Tailored Behavioral Intervention

Interventions

Social Cognitive Theory Tailored Behavioral InterventionBEHAVIORAL

The intervention will enhance self-efficacy

Behavioral Intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or less since type 2 diabetes was diagnosed

You may not qualify if:

  • more 5 years since type 2 diabetes was diagnosed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

January 29, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2018

Study Completion

September 1, 2018

Last Updated

October 19, 2016

Record last verified: 2016-10