- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440449
Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- The University of Texas Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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
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Other: Group B control arm
Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions.
|
A mobile app used to assist with lifestyle changes
An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
Time Frame: Baseline to 6 months
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Baseline to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycated Hemoglobin (HbA1c)
Time Frame: Baseline to 6 months
|
Change in HbA1c measured over the study period
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Baseline to 6 months
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Short Physical Performance Battery (SPPB) Balance
Time Frame: Baseline to 6 months
|
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.
|
Baseline to 6 months
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SPPB Gait Speed
Time Frame: Baseline to 6 months
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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:
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Baseline to 6 months
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SPPB Chair Stands
Time Frame: Baseline to 6 months
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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:
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Baseline to 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rozmin Jiwani, RN, PhD, University of Texas Health at San Antonio
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20190019H
- P30AG044271 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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