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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Weight, Body
Type 2 Diabetes
Frailty

Treatments

Behavioral: Lifestyle App
Behavioral: Abbreviated Look AHEAD behavior lifestyle intervention
Behavioral: Look AHEAD behavior lifestyle intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04440449
P30AG044271
HSC20190019H

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Behavioral Lifestyle Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Look AHEAD behavior lifestyle intervention
Behavioral: Lifestyle App
Group B control arm
Other group
Description:
Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions.
Treatment:
Behavioral: Abbreviated Look AHEAD behavior lifestyle intervention
Behavioral: Lifestyle App

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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