Building Self-regulation Capacity in AA T2DM Women: Feasibility of EMI

NCT04083248 | Terminated DMC

• 2 other identifiers: 2019-0922P30DK092949
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

In African-Americans, the incidence of type 2 diabetes (T2DM) is \~14%. Adherence to crucial diabetes self-management (DSM) behaviors, such as engaging in physical activity (PA) is dangerously low among AA women living in disadvantaged neighborhoods. These women manage numerous chronic challenges (daily discrimination, poverty, and violence), which drain the internal energy needed for DSM. The ability to self-regulate (modify one's behaviors based on the requirements of a situation) has been associated with adherence to health behaviors, including diet and PA. This 6-week ecological momentary intervention (EMI) feasibility study has been developed to reduce energy needs of DSM through use of self-regulation strategies delivered in real-time, in the real-world setting. Twenty-six AA women will receive personalized diabetes education over two days. They will be given a personalized activity prescription and a Fitbit wrist activity monitor. During the following two weeks, they will get a personal continuous glucose monitor (CGM) and individualized "cue cards" for simple behaviors they can try when glucose levels are too high. The intervention is grounded in self-regulation theory, and targets core self-regulation components, including self-monitoring/assessment, mental contrasting of target values with actual values, and goal-setting/review. The aim for this application is to Determine the feasibility and acceptability of an ecological momentary intervention, consisting of continuous glucose monitoring, activity tracking, and personalized cue cards with behavioral choices (eating/activity) driven by the results of glucose levels. Impact: Real-time feedback on the effects of activity and eating behaviors will enable patients to make choices and see results immediately. Our intervention will offer low-income African-American women opportunities to enact behaviors in their momentary environment, and will encourage autonomous motivation for PA uptake, and improving blood glucose control. Findings from this study will have an important positive impact on our ability to create tailored, EMIs among low-income adults who have limited access to diabetes specialty care and education.

Conditions

Type 2 Diabetes; Self-regulation

Outcome Measures

Primary Outcomes (6)

• Hours of CGM data

  Total number of hours of usable CGM data while worn.

  Post-intervention at week 6

• Number of times participants accessed their CGM data

  Total number of times the CGM receiver was used to access glucose readings by the participants each day.

  Post-intervention at week 6

• Wear time of Fitbit activity monitor

  Assessment of wear time will include average hours per day the device was worn.

  Post-intervention at week 6

• Interrelationships between real-time interstitial glucose levels (mg/dL) and activity levels (active minutes (correlation coefficients).

  Correlations between averaged daily glucose levels and average daily active minutes.

  Post intervention at week 6

• Interrelationships between real-time interstitial glucose levels (mg/dL) and activity levels (step counts).

  Correlations between averaged daily glucose levels and average daily step counts.

  Post intervention at week 6

• Acceptability of intervention: Semi-structured Diabetes Study Acceptability Interview Guide

  Semi-structured Diabetes Study Acceptability Interview Guide (developed by investigators). Open-ended questions will address: Overall experience; experiences with personalized education; helpfulness of group setting; Difficulty using devices, helpfulness of devices; interference with daily life; and any thoughts or suggestions for changes to the intervention.

  Post-intervention at week 6

Study Arms (1)

Feasibility group

EXPERIMENTAL

Intervention components: Personalized group diabetes education. Fitbit Charge 3 wrist activity monitor for real-time monitoring of steps, active minutes and heart rate. The Fitbit will be used by the women to set activity goals, self-assess their progress and aid in motivation to be more active. Freestyle Libre (Abbott Labs, Alameda, CA) Personal CGM (FDA approved). The Libre CGM will be used to self-monitor glucose goals and monitor the real-time effects of activity and eating choices by the women. Final guided interview for study acceptability and feasibility. The interviews will be audiotaped, transcribed. Thematic content analyses will be performed.

Behavioral: Feasibility group

Interventions

Feasibility group BEHAVIORAL

Same as arm description

Feasibility group

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American/Black female
• History of T2DM \> 1 year
• Age \> 40 years of age
• On non-insulin anti-diabetic therapy or diet-controlled
• Smartphone owner

You may not qualify if:

• Women with type 1 diabetes
• Women using insulin
• Any condition that would prohibit the ability to walk for 15-30 minutes or participate in light to moderate physical activity
• Low cognitive function (Mini-cog \<3)
• A1c \> 10%

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Chicago: collaborator

Study Sites (1)

University of Illinois at Chicago, College of Nursing

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Self-Control

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Social Behavior; Behavior

Study Officials

• Cynthia Fritschi, PhD, RN

  University of Illinois at Chicago, College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 10, 2019
• Study Start: September 20, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)