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Financial Incentives and Text Messaging to Improve African American Womens' Glycemic Control (FRIENDS-Text)

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ClinicalTrials.gov Identifier: NCT02384265
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Arleen F. Brown, MD, PhD, University of California, Los Angeles

Brief Summary:

Diabetes is a major public health problem that is associated with substantial health disparities for African American women compared to African American men or white men and women. This project will incorporate a) new technology whose use is high among African Americans (cell phone text message reminders), b) support from social networks, and c) strategies from the emerging field of behavioral economics to encourage and support self care behaviors that lead to improvements in diabetes control.

In Stage I of the study, the investigators conducted focus groups with women with diabetes and their family members and friends. The investigators used information from these groups to work with a team of community partners to develop recruitment protocols, prepare study documents (including flyers, Frequently Asked Questions sheets, and informed consent forms), and finalize participant surveys.

In the next phase of the study the investigators will evaluate ways that friends and family members can use direct support and text messages to improve control of blood sugar for African American women with type 2 diabetes. A team of three people--the Person With Diabetes (PWD) and 2 friends or family members, also known as the Support Team Members (STMs)--will be assigned at random to one of two groups to compare approaches to improving control of blood sugar. Each team will receive information and resources on improving diabetes control and will be linked by a text messaging program. The intervention team will receive additional text messaging support that may help them improve the PWD's diabetes control.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: IM/SMS + Incentive Condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Financial Incentives and SMS to Improve African American Womens' Glycemic Control: Friends & Relatives Improving the Effectiveness of Networks for Diabetes Support Through Text Messaging (FRIENDS Text)
Study Start Date : December 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IM/SMS + Incentive Condition
Participants in the intervention condition will consist of the PWD and their two STMs. The PWD and STM will receive the same protocols that the "Usual Care" participants receive, including an introductory educational session, written materials on diabetes, a blood glucose log, and a physical activity monitoring log. The PWDs in this condition will also receive training in action planning with their STMs. They will also receive SMS messages supporting diabetes self-care from the study team. The study team will also encourage the STMs to interaction in person and via text messages with the PWD.
Behavioral: IM/SMS + Incentive Condition
See description of Intervention arm protocols above.

No Intervention: Control
Control group participants will consist of the person with diabetes (PWD) and their two support team members (STM). The PWD will receive regular medical care from their usual providers. They will also receive an introductory educational session and written materials on diabetes, the importance of its control, and diabetes self-care strategies, and a blood glucose and physical activity monitoring log. They will be invited for study visits at 3, 6, and 12 months to measure cholesterol, A1c (for those with diabetes), blood pressure, height, and weight measurement. PWDs and STMs in the control condition will receive generic health promotion information during in-person visits or by mail. They will receive follow-up messages by text to remind them about study related events.



Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c at 12-months [ Time Frame: 12-months ]
    The investigators will measure the change in hemoglobin A1c (measured as % A1c).


Secondary Outcome Measures :
  1. Change from Baseline in Weight 12-months [ Time Frame: 12 months ]
    The investigators will measure the change in weight (measured in kg).

  2. Change from Baseline in Body Mass Index at 12-months [ Time Frame: 12 months ]
    The investigators will measure the change in Body Mass Index (measured in kg/meter2).

  3. Change from Baseline in Waist Circumference (inches) at 12-months [ Time Frame: 12 months ]
    The investigators will measure the change in waist circumference (measured in centimeters).

  4. Change from Baseline in Systolic and Diastolic Blood Pressure at 12-months [ Time Frame: 12 months ]
    The investigators will measure the change in systolic and diastolic blood pressure measured in mmHg.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible persons with diabetes (PWDs) will be identified either through the clinic diabetes registry, referrals from their providers, or direct recruitment by study staff during clinic hours. Eligible subjects are African American women seen at the clinic at least once in the prior 12 months, who have a record of at least one A1c reading in the past year (most recent A1c >8%), indicate that they plan to receive their diabetes care from the clinic over the next 18 months, and have a cell phone with an active plan, have two other individuals who they identify as friends or family members to enroll with them.
  • Eligible support team members (STMs) will be identified by the PWD as being a friend or family member 18 years or older and have a cell phone with an active plan.
  • To enroll in the study, there must be a triad (1 PWD and 2 STMs) that meet all study inclusion requirements. After the study begins, if one of the STMs drops out/withdrawals from the study, the team can continue to participate. However, if the PWD drops out/withdrawals from the study, the team will not be able to continue in the study and therefore, will be dropped from the study by the principal investigator.

Exclusion Criteria:

  • The investigators will exclude PWDs who are pregnant at the time of enrollment or those who only had diabetes during pregnancy, children, prisoners, homeless persons, institutionalized adults, and adults with type 1 diabetes, hemophilia, AIDS, cancer, hemoglobinopathies, or severe mental illness.
  • The investigators will exclude STMs who are younger than 18 years old or do not have a cell phone with an active plan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384265


Contacts
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Contact: Arleen F Brown, MD, PhD 310-794-6047 abrown@mednet.ucla.edu
Contact: Juan Barron, B.A. 310-794-0717 juanbarron@mednet.ucla.edu

Locations
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United States, California
Holman United Methodist Church Recruiting
Los Angeles, California, United States, 90018
Contact: Judi Wortham       judiwortham@gmail.com   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Arleen F Brown, M.D., Ph.D. University of California, Los Angeles
Publications:
Deci EL, Ryan RM. Intrinsic Motivation and Self-Determination in Human Behavior (Perspectives in Social Psychology). New York: Plenum Press; 1985.
Lepper M, Greene D, Nisbett R. Undermining children's intrinsic interest with extrinsic rewards: A test of the
Hackman J, Oldham G. Motivation through Design of Work-Test of a Theory. Organizational Behavior and Human Performance. 1976 1976;16:250-279.

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Responsible Party: Arleen F. Brown, MD, PhD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02384265    
Other Study ID Numbers: 1P60MD006923 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arleen F. Brown, MD, PhD, University of California, Los Angeles:
Diabetes
Disparities
Behavioral
Text messaging
Social networks
African American
Female
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases