NCT04440449

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

Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Frailty
• Weight, Body
• Type 2 Diabetes

Interventions

Type	Name	Description
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
BEHAVIORAL	Abbreviated Look AHEAD behavior lifestyle intervention	An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity

Timeline

• Start date: 2019-07-15
• Primary completion: 2020-10-20
• Completion: 2022-04-28
• First posted: 2020-06-19
• Last updated: 2022-05-24
• Results posted: 2021-07-16

Locations

1 site across 1 country: United States