Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
2 other identifiers
interventional
20
1 country
1
Brief Summary
The study team want to see if changes in lifestyle and behaviors and self-monitoring of diet and physical activity in older adults who have type 2 Diabetes (T2D) may help to prevent or reduce frailty. Frailty occurs in older adults and leads people to have falls, become disabled, require nursing home placement, and have increased risk of death. T2D is one of the major risk factors for frailty. T2D is a significant problem in older adults and is known to increase the risk of future frailty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2019
CompletedFirst Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2020
CompletedResults Posted
Study results publicly available
July 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2022
CompletedMay 24, 2022
May 1, 2022
1.3 years
June 17, 2020
May 4, 2021
May 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
1. Self-reported (SR) exhaustion (Y/N ) on Center for Epidemiologic Studies Depression (CES-D) scale: "Do you feel full of energy?" "No" scored a 1 (exhausted). 2. SR unintentional weight loss: "In the last year, have you lost more than 10 pounds unintentionally?". "Yes" scored a 1. 3. SR physical activity over the last year using the Minnesota Leisure Time Activity Questionnaire, (energy expenditure in kcal/week, standardized for sex). The lowest quintile for each sex group received a score of 1 4. Grip strength measured (Kg) with a dynamometer in the dominant hand, standardized using body mass index quartiles and sex. The average of 3 trials was recorded. The lowest quintile for each sex group received a score of 1 (for weak). 5. 10 feet walked at usual pace, standardized based on height and sex. The fastest of 2 trials was recorded. Participants in the lowest quintile for each sex group were considered slow (score =1) A higher scale score from 0-5 indicates greater frailty
Baseline to 6 months
Secondary Outcomes (4)
Glycated Hemoglobin (HbA1c)
Baseline to 6 months
Short Physical Performance Battery (SPPB) Balance
Baseline to 6 months
SPPB Gait Speed
Baseline to 6 months
SPPB Chair Stands
Baseline to 6 months
Study Arms (2)
Behavioral Lifestyle Intervention
EXPERIMENTALThe participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Group B control arm
OTHERParticipants use the smart-phone app to record their daily diet and physical activity, with no group sessions.
Interventions
A mobile app used to assist with lifestyle changes
A modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
Eligibility Criteria
You may qualify if:
- Community-dwelling
- Age 65 and older
- Men and women of all ethnic groups
- Self-reported of provider-diagnosed with Type 2 Diabetes (T2D) for at-least 6 months.
- Received basic diabetes self-management education
- Stable medication regimen and no medication changes are expected over the next 6 months.
- Overweight/obese (Body Mass Index (BMI) ≥25 kg/m2
- Able to read and write in English
- Own a smartphone
- At PI discretion, participant is willing/able to comply with the protocol requirements
You may not qualify if:
- Unsafe to walk using Exercise Assessment and Screening for You (EASY) criteria or clinical judgement of the PI.
- History of severe psychiatric disorders or cognitive impairment which interferes with active participation in the study
- Residence of long-term care facility
- History of substance abuse in the past year
- Unwilling to be randomized in a Mobile Health (mHealth+) individual intervention group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rozmin Jiwani
- Organization
- University of Texas Health San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Rozmin Jiwani, RN, PhD
University of Texas Health at San Antonio
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 19, 2020
Study Start
July 15, 2019
Primary Completion
October 20, 2020
Study Completion
April 28, 2022
Last Updated
May 24, 2022
Results First Posted
July 16, 2021
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will be available at study completion
- Access Criteria
- Study Teams plans on publication at completion of data analysis.
Information will be shared with mentors and advisors