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Type 2 Diabetes MellitusEMPOWERNCT01806194

Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

A study testing Lifestyle Counseling in people with Type 2 Diabetes Mellitus, run by East Carolina University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The EMPOWER diabetes program is a year-long, community-based program designed to enhance diabetes management in rural African American women with uncontrolled diabetes. The treatment is delivered by community peers and follows a relative Small Changes approach. Read more about this study

Who is it for?
Ages 19 to 75 years, women only
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Lifestyle Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
Jan 2012to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • African American female,
  • age 19 - 75yr.,
  • with Type 2 diabetes mellitus and
  • living in or near Bertie, Edgecombe, and Pitt counties in eastern NC

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • East Carolina University

    Greenville, North Carolina, 27834

Other trials in United States

About this study

The EMPOWER diabetes program is a year-long, community-based program designed to enhance diabetes management in rural African American women with uncontrolled diabetes. The treatment is delivered by community peers and follows a relative Small Changes approach.

Read the detailed description

East Carolina University, along with established community partners, is implementing a community-based and culturally-tailored intervention to reduce diabetes disparities in 200 rural African American women with uncontrolled diabetes using our unique behaviorally-centered small changes approach to diabetes self-management, delivered by community health workers. The focus is on moderation and patient-selected small changes in eating, activity, and care management that decrease feelings of deprivation and failure and increase feelings of confidence and success. The intervention is specifically tailored to overcome psychosocial and environmental barriers to behavioral change through a strong focus on emotional, cultural, and social factors related to eating, activity, and medications. Objectives for the proposed project are to: 1) implement and evaluate the effectiveness of this tailored small changes intervention; 2) examine the impact of this approach on psychological mediators of behavioral choices in diabetes; 3) implement and evaluate public policy and built environment advocacy strategies; and 4) build, sustain, and disseminate a business-sustainable care model. The study will be a randomized prospective trial comparing the small changes intervention, delivered in 16 sessions by community health workers, to a control group receiving 16 mailings of diabetes educational materials. We hypothesize that there will be a greater improvement in behavioral choices and glycemic control in the intervention group compared to the control group.

Being tested
Lifestyle Counseling, Educational Control Arm
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle CounselingBehavioural

    Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers

  • Educational Control ArmBehavioural

    16 mailings of diabetes educational materials but no regular contact with community health workers

Study groups in NCT01806194
Study groupRoleWhat they receive
Educational control armActive comparatorControl group receives 16 mailings of diabetes educational materials but no regular contact with community health workers
Receives: Behavioral: Educational Control Arm
Lifestyle counselingExperimentalSmall changes behavioral counseling and social support, delivered in 16 sessions by community health workers.
Receives: Behavioral: Lifestyle Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hemoglobin A1c

    Glycosylated hemoglobin

    Measured: 6 months

  2. Change in Hemoglobin A1c

    Glycosylated hemoglobin

    Measured: 12 Months

Secondary outcomes (2)

  1. Change in Weight

    Body weight

    Measured: 6 Months

  2. Change in Weight

    Body Weight

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01806194
Sponsor's protocol ID
212196
Acronym
EMPOWER
Status last verified
Jan 2016
First submitted
5 Dec 2012
Last updated
21 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Cummings DM, Lutes LD, Littlewood K, Dinatale E, Hambidge B, Schulman K. EMPOWER: a randomized trial using community health workers to deliver a lifestyle intervention program in African American women with Type 2 diabetes: design, rationale, and baseline characteristics. Contemp Clin Trials. 2013 Sep;36(1):147-53. doi: 10.1016/j.cct.2013.06.006. Epub 2013 Jun 19.

    PubMed 23792133

  • Cummings DM, Lutes L, Littlewood K, DiNatale E, Hambidge B, Schulman K, Morisky DE. Regimen-Related Distress, Medication Adherence, and Glycemic Control in Rural African American Women With Type 2 Diabetes Mellitus. Ann Pharmacother. 2014 Aug;48(8):970-977. doi: 10.1177/1060028014536532. Epub 2014 Jun 5.

    PubMed 24904183

  • Lutes LD, Cummings DM, Littlewood K, Dinatale E, Hambidge B. A Community Health Worker-Delivered Intervention in African American Women with Type 2 Diabetes: A 12-Month Randomized Trial. Obesity (Silver Spring). 2017 Aug;25(8):1329-1335. doi: 10.1002/oby.21883. Epub 2017 Jun 29.

    PubMed 28660719

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Counseling in people with Type 2 Diabetes Mellitus, run by East Carolina University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin A1c (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01806194, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.

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