FrailtyNCT04440449
Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
A study testing Lifestyle App, Look AHEAD behavior lifestyle intervention and Abbreviated Look AHEAD behavior lifestyle intervention in people with Frailty and Weight, Body, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Weight, Body, Type 2 Diabetes
- What is being tested?
- Lifestyle App, Look AHEAD behavior lifestyle intervention and Abbreviated Look AHEAD behavior lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study
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.
Read the 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.
- Conditions
- Frailty, Weight, Body, Type 2 Diabetes
- Being tested
- Lifestyle App, Look AHEAD behavior lifestyle intervention, Abbreviated Look AHEAD behavior lifestyle intervention
- Medical subject headings
- Frailty, Body Weight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle AppBehavioural
A mobile app used to assist with lifestyle changes
Look AHEAD behavior lifestyle interventionBehavioural
A modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
Abbreviated Look AHEAD behavior lifestyle interventionBehavioural
An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Lifestyle Intervention | Experimental | 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. Receives: Behavioral: Lifestyle App; Behavioral: Look AHEAD behavior lifestyle intervention |
| Group B control arm | Other | Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions. Receives: Behavioral: Lifestyle App; Behavioral: Abbreviated Look AHEAD behavior lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 6 months
Secondary outcomes (4)
Glycated Hemoglobin (HbA1c)
Change in HbA1c measured over the study period
Measured: Baseline to 6 months
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
Measured: Baseline to 6 months
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
Measured: Baseline to 6 months
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
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start15 Jul 2019
- Primary completion20 Oct 2020
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * Group A - Mobile Health + group intervention * Group B (control arm)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Rozmin Jiwani, The University of Texas Health Science Center at San Antonio
- Investigators
- Rozmin Jiwani, RN, PhD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440449
- Sponsor's protocol ID
- HSC20190019H
- Other IDs
- P30AG044271
- Status last verified
- May 2022
- First submitted
- 17 Jun 2020
- Last updated
- 24 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information will be shared with mentors and advisors
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT04440449
- Acronym / sponsor ID
- HSC20190019H
- Conditions
- Frailty, Weight, Body, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Posted 16 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Group A - Mobile Health + group intervention * Group B (control arm)
| Arm | Type | Receives |
|---|---|---|
| Behavioral Lifestyle Intervention | Experimental | Behavioral: Lifestyle App, Behavioral: Look AHEAD behavior lifestyle interventionThe 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 | Other | Behavioral: Lifestyle App, Behavioral: Abbreviated Look AHEAD behavior lifestyle interventionParticipants use the smart-phone app to record their daily diet and physical activity, with no group sessions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle AppA mobile app used to assist with lifestyle changes | Behavioural | Behavioral Lifestyle Intervention, Group B control arm |
| Look AHEAD behavior lifestyle interventionA modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity | Behavioural | Behavioral Lifestyle Intervention |
| Abbreviated Look AHEAD behavior lifestyle interventionAn abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity | Behavioural | Group B control arm |
Primary outcome
Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
Time frame: Baseline to 6 months
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
4 secondary outcomes
Glycated Hemoglobin (HbA1c)
Time frame: Baseline to 6 months
Short Physical Performance Battery (SPPB) Balance
Time frame: Baseline to 6 months
SPPB Gait Speed
Time frame: Baseline to 6 months
SPPB Chair Stands
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- J. Frailty Aging 2021 April 24: 1-9Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information will be shared with mentors and advisors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rozmin Jiwani, RN, PhD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle App, Look AHEAD behavior lifestyle intervention and Abbreviated Look AHEAD behavior lifestyle intervention in people with Frailty and Weight, Body, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.