Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
Primary Purpose
Frailty, Weight, Body, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle App
Look AHEAD behavior lifestyle intervention
Abbreviated Look AHEAD behavior lifestyle intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Frailty
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- The University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Behavioral Lifestyle Intervention
Group B control arm
Arm Description
The 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.
Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions.
Outcomes
Primary Outcome Measures
Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
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).
SR unintentional weight loss: "In the last year, have you lost more than 10 pounds unintentionally?". "Yes" scored a 1.
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
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).
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
Secondary Outcome Measures
Glycated Hemoglobin (HbA1c)
Change in HbA1c measured over the study period
Short Physical Performance Battery (SPPB) Balance
The balance test assesses a person's ability to stand with the feet together in side-by-side, semi-tandem, and full-tandem positions for 10 seconds each, responses ranging between 0-4 with a higher score indicating better balance. Three balance tests are performed and scoring is as follows:
Side-by-side stand: person attempts to stand with feet together, side-by-side, for 10 seconds.
1 point if held for 10 seconds
0 points if not held for 10 seconds or not attempted Semi-tandem stand: person attempts to stand with the side of the heel of one foot touching the big toe of the other foot for 10 seconds.
1 point if held for 10 seconds
0 points if not held for 10 seconds or not attempted Tandem stand: person attempts to stand with the heel of one foot in front of and touching the toes of the other foot for about 10 seconds.
2 points if held for 10 seconds
1 point if held for 3 to 9.99 seconds
0 points if held for <3 seconds or not attempted
SPPB Gait Speed
Gait speed at a 4-meter walk is timed in seconds as participants walk at their usual pace. Two trials were administered, time (in seconds) was recorded for each trial. The fastest walk of two trials was recorded. Score is recorded between 0-4 with a higher score indicating a faster gait speed. Scoring is as follows:
0 points if unable to do the walk
1 point if time is more than 8.70 sec
2 points if time is 6.21 to 8.70 sec
3 points if time is 4.82 to 6.20 sec
4 points if time is less than 4.82 sec
SPPB Chair Stands
Chair stand represents the time to complete five chair rises, sit to stand from a chair, as quickly as possible, without using hands, responses ranging between 0-4. Scoring is as follows:
0 points if unable to complete 5 chair stands or completes stands in >60 seconds
1 point if chair stand time is 16.70 sec or more
2 points if chair stand time is 13.70 to 16.69 sec or more
3 points if chair stand time is 11.20 to 13.69 sec
4 points if chair stand time is 11.19 sec or less
Full Information
NCT ID
NCT04440449
First Posted
June 17, 2020
Last Updated
May 3, 2022
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04440449
Brief Title
Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
Official Title
Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
April 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)
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 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.
Detailed Description
Behavioral lifestyle intervention: Participants (N=40) will be randomized to the mHealth+ group Intervention group (Group A; n=20)and mHealth+ individual intervention group (Group B; n=20) group using a randomization table. (1) The mHealth+ group Intervention group (Group A) will receive a modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity. This comprises ten group sessions for lifestyle intervention in 6-months. The group will receive three weekly classes in the first month and then bi-weekly classes for month 2-3, and three monthly session in month four, five, and six. The frequency and layout of these classes will allow participants to master new skills gradually, then eventually wean off, and adopt the modified lifestyle as the part of their daily lives. (2) The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months). The goal for these follow up phone calls are to assess understanding of the modules, to promote continued engagement with the study material, and to provide clarification on materials as needed. Participants in the mHealth+ group Intervention group (Group A) and mHealth+ individual intervention group (Group B will receive instruction on how to download an app to help them record their diet and physical activity at the beginning of the study.
Fitbit offers a simple, easy-to-use tool for tracking food and physical activity. It helps set daily calorie budget, and set and work towards goals for nutrient intake, weight loss, exercise, and more. https://www.fitbit.com/inspire 04.12.20: Due to SARS-CoV2 (COVID-19) and social distancing order, the study team are adding hemoglobin Hba1c home test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Weight, Body, Type 2 Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A - Mobile Health + group intervention
Group B (control arm)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Lifestyle Intervention
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Group B control arm
Arm Type
Other
Arm Description
Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle App
Intervention Description
A mobile app used to assist with lifestyle changes
Intervention Type
Behavioral
Intervention Name(s)
Look AHEAD behavior lifestyle intervention
Intervention Description
A modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Abbreviated Look AHEAD behavior lifestyle intervention
Intervention Description
An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
Primary Outcome Measure Information:
Title
Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
Description
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).
SR unintentional weight loss: "In the last year, have you lost more than 10 pounds unintentionally?". "Yes" scored a 1.
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
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).
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
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Glycated Hemoglobin (HbA1c)
Description
Change in HbA1c measured over the study period
Time Frame
Baseline to 6 months
Title
Short Physical Performance Battery (SPPB) Balance
Description
The balance test assesses a person's ability to stand with the feet together in side-by-side, semi-tandem, and full-tandem positions for 10 seconds each, responses ranging between 0-4 with a higher score indicating better balance. Three balance tests are performed and scoring is as follows:
Side-by-side stand: person attempts to stand with feet together, side-by-side, for 10 seconds.
1 point if held for 10 seconds
0 points if not held for 10 seconds or not attempted Semi-tandem stand: person attempts to stand with the side of the heel of one foot touching the big toe of the other foot for 10 seconds.
1 point if held for 10 seconds
0 points if not held for 10 seconds or not attempted Tandem stand: person attempts to stand with the heel of one foot in front of and touching the toes of the other foot for about 10 seconds.
2 points if held for 10 seconds
1 point if held for 3 to 9.99 seconds
0 points if held for <3 seconds or not attempted
Time Frame
Baseline to 6 months
Title
SPPB Gait Speed
Description
Gait speed at a 4-meter walk is timed in seconds as participants walk at their usual pace. Two trials were administered, time (in seconds) was recorded for each trial. The fastest walk of two trials was recorded. Score is recorded between 0-4 with a higher score indicating a faster gait speed. Scoring is as follows:
0 points if unable to do the walk
1 point if time is more than 8.70 sec
2 points if time is 6.21 to 8.70 sec
3 points if time is 4.82 to 6.20 sec
4 points if time is less than 4.82 sec
Time Frame
Baseline to 6 months
Title
SPPB Chair Stands
Description
Chair stand represents the time to complete five chair rises, sit to stand from a chair, as quickly as possible, without using hands, responses ranging between 0-4. Scoring is as follows:
0 points if unable to complete 5 chair stands or completes stands in >60 seconds
1 point if chair stand time is 16.70 sec or more
2 points if chair stand time is 13.70 to 16.69 sec or more
3 points if chair stand time is 11.20 to 13.69 sec
4 points if chair stand time is 11.19 sec or less
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rozmin Jiwani, RN, PhD
Organizational Affiliation
University of Texas Health at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information will be shared with mentors and advisors
IPD Sharing Time Frame
Data will be available at study completion
IPD Sharing Access Criteria
Study Teams plans on publication at completion of data analysis.
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8068458/
Description
J. Frailty Aging 2021 April 24: 1-9
Learn more about this trial
Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
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