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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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).
- Change from Baseline in Weight 12-months [ Time Frame: 12 months ]The investigators will measure the change in weight (measured in kg).
- 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).
- 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).
- 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.
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
|Contact: Arleen F Brown, MD, PhDfirstname.lastname@example.org|
|Contact: Juan Barron, B.A.||email@example.com|
|United States, California|
|Holman United Methodist Church||Recruiting|
|Los Angeles, California, United States, 90018|
|Contact: Judi Wortham firstname.lastname@example.org|
|Principal Investigator:||Arleen F Brown, M.D., Ph.D.||University of California, Los Angeles|