Resilient, Empowered, Active Living: REAL Diabetes Study (REAL)

October 2, 2019 updated by: Beth Pyatak, University of Southern California

Diabetes Self-Management Lifestyle Intervention for Urban Minority Young Adults

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • USC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle intervention
Resilient, Empowered, Active Living (REAL) Diabetes
Behavioral: Resilient, Empowered, Active Living with Diabetes
Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive a total of 10-16 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the REAL Diabetes intervention protocol.
Active Comparator: Information Control
Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose.
Behavioral: Information Control
Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose. The packet of materials will be delivered in an initial home visit. Follow-up phone calls will occur at approximately two week intervals to inquire whether participants have reviewed specific sections of the intervention materials, and clarify information included in the packet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (HbA1C)
Time Frame: Baseline & 6 months.
Measure of average blood glucose concentration over approximately the previous 12 weeks.
Baseline & 6 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1K01DK099202-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Resilient, Empowered, Active Living with Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe