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Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes

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ClinicalTrials.gov Identifier: NCT04440449
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Collaborators:
Claude D. Pepper Older Americans Independence Center
National Institute on Aging (NIA)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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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.

Condition or disease Intervention/treatment Phase
Frailty Weight, Body Type 2 Diabetes Behavioral: Lifestyle App Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Group A - Mobile Health + group intervention
  • Group B - Mobile Health + individual intervention
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A
This group 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.
 Behavioral: Lifestyle App
A mobile app used to assist with lifestyle changes
Active Comparator: Group B
This group will receive a behavior lifestyle intervention with a smartphone-based self-monitoring of diet and physical activity. This group will also have an individual, face-to-face session at the beginning of the study and monthly follow-up phone calls.
 Behavioral: Lifestyle App
A mobile app used to assist with lifestyle changes


Outcome Measures
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Primary Outcome Measures :
  1. Frailty Scale [ Time Frame: Baseline to 6 months ]
    Change in frailty measured on a scale using a frailty score (0, 1, 2, 3, 4,or 5), with higher scores out of 5 representing greater frailty. Assessments used for scoring include 1) self reported weight loss, 2) self-reported exhaustion 3) low physical activity based on the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ) 4) Handgrip strength 5) 10 foot walk pace


Secondary Outcome Measures :
  1. Glycated hemoglobin (HbA1c) [ Time Frame: Baseline to 6 months ]
    Change in HbA1c measured over the study period

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline to 6 months ]
    For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

  3. Short Physical Performance Battery (SPPB) [ Time Frame: Baseline to 6 months ]
    The study team will administer the Short Physical Performance Battery (SPPB)69 to assess three lower extremity tasks; 1) standing balance (ability to stand with the feet together in side-by-side, semi-and full-tandem positions for 10 seconds each); 2) a 4-meter walk to assess usual gait speed; 3) time to complete 5 repeated chair stand. Each of the 3 performance measures is assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create a score ranging from 0 to 12 (best). The SPPB is sensitive to change over time


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440449


Contacts
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Contact: Rozmin Jiwani, RN, PhD 210-639-0398 jiwani@uthscsa.edu
Contact: Sara Espinoza, MD 210-617-5197 espinozas@uthscsa.edu

Locations
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United States, Texas
The University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Claude D. Pepper Older Americans Independence Center
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Rozmin Jiwani, RN, PhD University of Texas Health at San Antonio
More Information
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04440449    
Other Study ID Numbers: HSC20190019H
P30AG044271 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information will be shared with mentors and advisors
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Data will be available at study completion
Access Criteria: Study Teams plans on publication at completion of data analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Frailty
Body Weight
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pathologic Processes