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NCT04440449 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by The University of Texas Health Science Center at San Antonio.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT04440449: Completed NA study, sponsored by The University of Texas Health Science Center at San Antonio.

NCT04440449 is a NA study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04440449, a NA study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study 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.

Primary Outcome

1. Self-reported (SR) exhaustion (Y/N ) on Center for Epidemiologic Studies Depression (CES-D) scale: "Do you feel full of energy?" "No" scored a 1 (exhausted). 2. SR unintentional weight loss: "In the last year, have you lost more than 10 pounds unintentionally?". "Yes" scored a 1. 3. SR physical activity over the last year using the Minnesota Leisure Time Activity Questionnaire, (energy expenditure in kcal/week, standardized for sex). The lowest quintile for each sex group received a score of

Interventions

  • BEHAVIORAL Lifestyle App
  • BEHAVIORAL Look AHEAD behavior lifestyle intervention
  • BEHAVIORAL Abbreviated Look AHEAD behavior lifestyle intervention

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-07-15
Est. Completion 2022-04-28
Phase NA

What the finished NCT04440449 record still lists

NCT04440449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which Lifestyle App is the first listed.

NCT04440449 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04440449 about?

NCT04440449 is a clinical study titled "Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes". 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 hom...

What is the current status of trial NCT04440449?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2019-07-15. Estimated completion is 2022-04-28.

What interventions are being tested in trial NCT04440449?

The interventions under investigation include: Lifestyle App (BEHAVIORAL), Look AHEAD behavior lifestyle intervention (BEHAVIORAL), Abbreviated Look AHEAD behavior lifestyle intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT04440449?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04440449's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04440449, the US trial registry maintained by the National Library of Medicine. NCT04440449 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.