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
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Condition or disease | Intervention/treatment | Phase |
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Frailty Weight, Body Type 2 Diabetes | Behavioral: Lifestyle App | Not Applicable |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: |
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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 |

Arm | Intervention/treatment |
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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.
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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 |
- 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
- Glycated hemoglobin (HbA1c) [ Time Frame: Baseline to 6 months ]Change in HbA1c measured over the study period
- 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.
- 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

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Rozmin Jiwani, RN, PhD | 210-639-0398 | jiwani@uthscsa.edu | |
Contact: Sara Espinoza, MD | 210-617-5197 | espinozas@uthscsa.edu |
United States, Texas | |
The University of Texas Health Science Center at San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Rozmin Jiwani, RN, PhD | University of Texas Health at San Antonio |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus Frailty Body Weight Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pathologic Processes |