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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 : Active, not recruiting
First Posted : June 19, 2020
Results First Posted : July 16, 2021
Last Update Posted : July 16, 2021
Sponsor:
Collaborators:
The Claude D. Pepper Older Americans Independence Centers
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Rozmin Jiwani, 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 Behavioral: Look AHEAD behavior lifestyle intervention Behavioral: Abbreviated Look AHEAD behavior lifestyle intervention 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)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Group A - Mobile Health + group intervention
  • Group B (control arm)
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
Actual Primary Completion Date : October 20, 2020
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
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.
 Behavioral: Lifestyle App
A mobile app used to assist with lifestyle changes

Behavioral: 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.
 Behavioral: Lifestyle App
A mobile app used to assist with lifestyle changes

Behavioral: Abbreviated Look AHEAD behavior lifestyle intervention
An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity


Outcome Measures
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Primary Outcome Measures :
  1. 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


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

  2. 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.

    • 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

  3. SPPB Gait Speed [ Time Frame: Baseline to 6 months ]

    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

  4. SPPB Chair Stands [ Time Frame: Baseline to 6 months ]

    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


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


Locations
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United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
The Claude D. Pepper Older Americans Independence Centers
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Rozmin Jiwani, RN, PhD University of Texas Health at San Antonio
  Study Documents (Full-Text)

Documents provided by Rozmin Jiwani, The University of Texas Health Science Center at San Antonio:
Study Protocol and Statistical Analysis Plan  [PDF] October 20, 2020

More Information
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Additional Information:

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Responsible Party: Rozmin Jiwani, Assistant Professor, 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
Results First Posted: July 16, 2021
Last Update Posted: July 16, 2021
Last Verified: July 2021
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