Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
NCT ID: NCT04440449
Last Updated: 2022-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-07-15
2022-04-28
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
* Group B (control arm)
SUPPORTIVE_CARE
NONE
Study Groups
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Behavioral Lifestyle Intervention
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.
Lifestyle App
A mobile app used to assist with lifestyle changes
Look AHEAD behavior lifestyle intervention
A modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
Group B control arm
Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions.
Lifestyle App
A mobile app used to assist with lifestyle changes
Abbreviated Look AHEAD behavior lifestyle intervention
An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
Interventions
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Lifestyle App
A mobile app used to assist with lifestyle changes
Look AHEAD behavior lifestyle intervention
A modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
Abbreviated Look AHEAD behavior lifestyle intervention
An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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The Claude D. Pepper Older Americans Independence Centers
OTHER
National Institute on Aging (NIA)
NIH
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Rozmin Jiwani
Assistant Professor
Principal Investigators
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Rozmin Jiwani, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health at San Antonio
Locations
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The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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J. Frailty Aging 2021 April 24: 1-9
Other Identifiers
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HSC20190019H
Identifier Type: -
Identifier Source: org_study_id
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