Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study
Completed · Not applicable
Conditions studied: Frailty
In brief
The Supporting Habit Formation to Attenuate Prefrailty in Elders (SHAPE) Pilot Study is a randomized control study. The main objective of this pilot study is to determine the feasibility of using Habit Formation (HF) treatment to increase Physical Activity (PA) (reduction in daily in hours of sedentary time), and dietary among prefrail African Americans. We hypothesize: (1)The SHAPE study will demonstrate good feasibility with a high recruitment rate and successful administration all of the measures among the target population; (2) Treatment group participants will demonstrate greater increases in primary outcomes (physical activity level and dietary quality) and secondary outcomes (quality of life, depressive symptoms, prefrailty reduction, lower extremity strength and balance, physical activity level, waist circumference, and weight at intervention completion.
Key facts
- Study ID
- NCT04140890
- Run by
- Wayne State University
- People needed
- 30
- Starts
- 2019-09-30
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2020-11-23
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- English-speaking
- Community-dwelling
- Prefrail (evaluated by the Frailty scale)
- Self-identify as African Americans.
You may not qualify if…
- Diagnosed psychiatric disorders,
- Moderate or severe cognitive impairment (using the Six Item Cognitive Impairment Test and operationalized as a score of ≥ 10),
- Using prescription drugs that could affect cognition and functioning (e.g., neuroleptics), - - Individuals with typical daily pain ratings of ≥ 7/10 on a 10 point Likert scale of pain
- Planing to change residences during the study period
- Relying on a wheelchair for home or community mobility
- Actively receiving home care services, occupational, or physical therapy
- On dialysis or who have an end of stage disease (e.g., stage IV heart failure)
- Enrolling in a health promotion program focused on physical activity and diet
- Have a baseline healthy eating index score of ≥ 85/100 as their diet would already be very close to ideal (average score for U.S. population = 59)
Where it is running
- Eugene Applebaum College of Pharmacy and Health Sciences — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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