Clinical trial NCT04440449: Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
Official title: Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Weight, Body
Type 2 Diabetes
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: The Claude D. Pepper Older Americans Independence Centers
name: National Institute on Aging (NIA)
First posted: 2020-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Group A - Mobile Health + group intervention
* Group B (control arm)
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Glycated Hemoglobin (HbA1c)
timeFrame: Baseline to 6 months
measure: Short Physical Performance Battery (SPPB) Balance
timeFrame: Baseline to 6 months
measure: SPPB Gait Speed
timeFrame: Baseline to 6 months
measure: SPPB Chair Stands
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Rozmin Jiwani, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: