N/A N=20 Supportive Care

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

Frailty · Weight, Body · Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT04440449 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics — 1.61; 0.94 score on a scale — p=0.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lifestyle App (Behavioral); Look AHEAD behavior lifestyle intervention (Behavioral); Abbreviated Look AHEAD behavior lifestyle intervention (Behavioral)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center at San Antonio
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics	1.61; 0.94	0.01 sig
SECONDARY Glycated Hemoglobin (HbA1c)	6.95; 6.75	0.108
SECONDARY Short Physical Performance Battery (SPPB) Balance	3.39; 3.89	—
SECONDARY SPPB Gait Speed	3.61; 3.72	—
SECONDARY SPPB Chair Stands	2.28; 2.44	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04440449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.