Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04440449
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2020-06-17
Brief Title:
Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes A Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N40 will be randomized to the mHealth group Intervention group Group A n20and mHealth individual intervention group Group B n20 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 httpswwwfitbitcominspire 041220 Due to SARS-CoV2 COVID-19 and social distancing order the study team are adding hemoglobin Hba1c home test
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 httpswwwfitbitcominspire 041220 Due to SARS-CoV2 COVID-19 and social distancing order the study team are adding hemoglobin Hba1c home test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG044271 | NIH | None | httpsreporternihgovquickSearchP30AG044271 |