N/A
N=21
Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study
Frailty
Bottom Line
View on ClinicalTrials.gov: NCT04140890 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants Completed the Study — 9; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Habit Formation (Behavioral); Education (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Wayne State University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Completed the Study |
9; 11 | — |
| PRIMARY Seven-days Average Sedentary Time (Minutes/Day) |
551.9; 555.5; 565; 582.3 | — |
| PRIMARY Healthy Eating Index Score |
44.4; 46.7; 46.9; 46.9 | — |
| SECONDARY The The World Health Organization Quality of Life- BREF |
78.1; 72.7; 78.6; 73.1; 72.2; 83.3 | — |
| SECONDARY Geriatric Depression Short Form (GDS) |
2.3; 1.3; 3.9; 1.6 | — |
| SECONDARY The Fried's Frailty Criteria Index |
1.9; 0.9; 1.6; 0.9 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
6.8; 7.1; 7.6; 7.3 | — |
| SECONDARY The Community Healthy Activities Model Program for Seniors (CHAMPS) |
1915.6; 2014.4; 2694.5; 1838.1 | — |
| SECONDARY Waist Circumference |
40.8; 39.7; 40.1; 40 | — |
| SECONDARY Weight |
172; 177.8; 172.5; 179.5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- English-speaking
- Community-dwelling
- Prefrail (evaluated by the Frailty scale)
- Self-identify as African Americans.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04140890). 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.