Back to resultsMedical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
Primary Purpose
Type 2 Diabetes, Physical Disability
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-Tech
Low-Tech
Attention Control
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: Diagnosis of T2DM 18 to 65 years of age Living with a permanent physical disability such as SCI, spina bifida, multiple sclerosis, stroke Ability to converse in and read English Availability of a smartphone or computer that can run apps Have internet connection capabilities Exclusion Criteria: Current enrollment in any diabetes related intervention Present or soon-planned pregnancy Major heart attack or heart surgery in the past 12 months Have undergone a dialysis, kidney transplant or a kidney surgery in the past 12 months Severe cognitive impairment Severe untreated depression in the past 6 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Experimental: High-Tech Intervention Group
Experimental: Low-Tech Intervention Group
Active Comparator: Attention Control Group
Arm Description
Those in the high-tech intervention group will receive 6 months of active intervention (up to 60 minutes weekly health coaching calls and content delivery) and technology access.
Those in low-tech group will receive 6 months of one weekly coaching calls (last up to 60 minutes) and one weekly email
The control group will be used to provide an untreated comparison for the intervention groups and will not receive MNT or technology support. Participants in the control arm will only get a baseline and post-intervention testing.
Outcomes
Primary Outcome Measures
Diabetes Quality of Life
Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome
Psychological Distress
Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome
Self-efficacy
Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome
Secondary Outcome Measures
Glycemic Management
Measured using HbA1c
Full Information
NCT ID
NCT06049225
First Posted
August 24, 2023
Last Updated
September 14, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT06049225
Brief Title
Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
Official Title
Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to develop, and pilot test an accessible and inclusive medical nutrition therapy and diabetes self-management education program for people with Type 2 Diabetes and physical disabilities.
Detailed Description
This study will use a three-arm randomized control trial design. Eligible and consented participants will be assigned to one of three groups: (1) intervention with high-tech support, (2) intervention with low-tech support, and (3) attention-control group. The active intervention period will include six months of weekly health coaching calls and technology access. The low-tech support group will receive six months of weekly coaching calls and weekly email containing related materials in PDF format but no video and technology content.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Physical Disability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: High-Tech Intervention Group
Arm Type
Experimental
Arm Description
Those in the high-tech intervention group will receive 6 months of active intervention (up to 60 minutes weekly health coaching calls and content delivery) and technology access.
Arm Title
Experimental: Low-Tech Intervention Group
Arm Type
Experimental
Arm Description
Those in low-tech group will receive 6 months of one weekly coaching calls (last up to 60 minutes) and one weekly email
Arm Title
Active Comparator: Attention Control Group
Arm Type
Active Comparator
Arm Description
The control group will be used to provide an untreated comparison for the intervention groups and will not receive MNT or technology support. Participants in the control arm will only get a baseline and post-intervention testing.
Intervention Type
Behavioral
Intervention Name(s)
High-Tech
Intervention Description
Access to technological platform and weekly health coaching
Intervention Type
Behavioral
Intervention Name(s)
Low-Tech
Intervention Description
Weekly email with educational content and weekly health coaching
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
No technology access or health coaching
Primary Outcome Measure Information:
Title
Diabetes Quality of Life
Description
Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome
Time Frame
24 weeks
Title
Psychological Distress
Description
Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome
Time Frame
234 weeks
Title
Self-efficacy
Description
Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Glycemic Management
Description
Measured using HbA1c
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Physical Activity
Description
Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome
Time Frame
24 weeks
Title
Dietary intake
Description
Measured using The US version of the Diabetes and Diet Questionnaire
Time Frame
24 weeks
Title
Medication Adherence
Description
Measured using the Medication Adherence Rating Scale
Time Frame
24 weeks
Title
Health Dashboard Usability
Description
Measured using the System Usability Scale; Maximum item score (Strongly agree) = 5, minimum item score (Strongly disagree) = 1; Higher scores represent better outcomes
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of T2DM
18 to 65 years of age
Living with a permanent physical disability such as SCI, spina bifida, multiple sclerosis, stroke
Ability to converse in and read English
Availability of a smartphone or computer that can run apps
Have internet connection capabilities
Exclusion Criteria:
Current enrollment in any diabetes related intervention
Present or soon-planned pregnancy
Major heart attack or heart surgery in the past 12 months
Have undergone a dialysis, kidney transplant or a kidney surgery in the past 12 months
Severe cognitive impairment
Severe untreated depression in the past 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anita Aboagye
Phone
857-453-9502
Email
aboagyea@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mohanraj Thirumalai
Phone
205-934-7189
Email
mohanraj@uab.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29567642
Citation
American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22.
Results Reference
background
PubMed Identifier
14501578
Citation
Hall L, Colantonio A, Yoshida K. Barriers to nutrition as a health promotion practice for women with disabilities. Int J Rehabil Res. 2003 Sep;26(3):245-7. doi: 10.1097/00004356-200309000-00013.
Results Reference
background
PubMed Identifier
19447843
Citation
Kayes NM, Schluter PJ, McPherson KM, Taylor D, Kolt GS. The Physical Activity and Disability Survey -- Revised (PADS-R): an evaluation of a measure of physical activity in people with chronic neurological conditions. Clin Rehabil. 2009 Jun;23(6):534-43. doi: 10.1177/0269215508101750. Epub 2009 May 15.
Results Reference
background
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Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
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