Resilient, Empowered, Active Living: REAL Diabetes Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Interventions: Behavioral: Information Control; Behavioral: Resilient, Empowered, Active Living with Diabetes

• Registration Number: NCT02214641
• Lead Sponsor: University of Southern California

Brief Summary

This three-year award will pilot-test an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merges findings of an in-depth needs assessment, principles of an evidence-based occupational therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management strategies. A proof-of-concept study demonstrated that REAL is feasible to implement, acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to produce positive changes in diabetes self-care and glycemic control. The study will randomize 80 young adults with diabetes to receive either the six-month REAL intervention or an attention control condition. Blinded data collectors will assess glycemic control, diabetes self-care behaviors and quality of life outcomes, as well as potential intervention mediators, before and after the six-month intervention. It is anticipated that findings from this pilot study will be used to inform a large-scale randomized controlled trial of the REAL intervention.

The study's specific aims and hypotheses are as follows:

Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and diabetes self-care.

Hypothesis: At 6 months (immediately following the intervention), intervention group participants will demonstrate improvements in A1C and diabetes self-care as compared to control group participants.

Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and potential mediating mechanisms (to inform power estimates for a large-scale RCT).

Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in secondary outcomes: diabetes-related stress and quality of life, depression, and life satisfaction as compared to control group participants.

Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in potential mediators of the intervention: habit strength, problem solving, activity participation, self-efficacy and diabetes knowledge as compared to baseline.

Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment, retention, testing protocol).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-08
• Study First Posted: 2014-08-12
• Study Start: 2014-10
• Primary Completion: 2016-06
• Study Completion: 2017-07
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Diagnosed with type 1 or type 2 diabetes mellitus for a minimum of 12 months
• Most recent A1C ≥8.0%
• Fluent in English or Spanish
• Reachable by telephone or text message
• Willing to participate in study activities
• Reside in Los Angeles County with no plans to relocate

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Exclusion Criteria

• Pregnant or planning to become pregnant
• Cognitive impairment or severe disability limiting life expectancy
• Participated in lifestyle intervention targeting diabetes within past 12 months
• Participated in formative research related to intervention development.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Information Control	Information Control	Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose.
Lifestyle intervention	Resilient, Empowered, Active Living with Diabetes	Resilient, Empowered, Active Living (REAL) Diabetes

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1C)	Baseline & 6 months.	Measure of average blood glucose concentration over approximately the previous 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Summary of Diabetes Self-Care Activities (SDSCA)	Baseline & 6 months	14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.
Problem Areas in Diabetes (PAID) Scale - Short Form	Baseline & 6 months.	5-item survey measure assessing diabetes-related distress and emotional problems.
Audit of Diabetes-Dependent Quality of Life (ADD-QoL)	Baseline & 6 months.	19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.
Patient Health Questionnaire-8 (PHQ-8)	Baseline & 6 months	8-item survey measure assessing severity of depressive symptoms (identical to PHQ-9 while omitting self-harm item).
Satisfaction With Life Scale (SWLS)	Baseline & 6 months.	5-item survey measure assessing global life satisfaction and subjective well-being.

Trial Locations

Locations (1)

USC; 🇺🇸 Los Angeles, California, United States