Clinical trial NCT04140890: Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study
Official title: Supporting Habit Formation to Attenuate Prefrailty in Elders: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: prefrail
habit
exercise
diet
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The treatment group will receive healthy habit intervention, and the control group will receive attention control.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Frailty signifies a decline in physical, cognitive and/or psychosocial reserve that reduces an older adult's ability to respond to or recover from stressors (e.g., acute illness) and contributes to early morbidity and mortality. Nearly half of all older adults are prefrail, and prefrailty status increases the risk of becoming frail. Frailty is more prevalent among African Americans and occurs earlier in life when compared to European Americans. Older African Americans in the US, face significant challenges in adhering to frailty reduction treatment such as increasing physical activity (PA) and adopt a healthy diet. Those challenges include poverty, accelerated aging, higher levels of activities of daily living disability, and less access to safe opportunities for PA or healthy food. The situation is even worse for urban-dwelling older African Americans, who often reside in neighborhoods replete with physical and social stressors (e.g., derelict infrastructure or crime) that intersect with the vulnerabilities of aging, to further complicate their efforts to engage in frailty protective behaviors. Despite this, frailty interventions overwhelmingly exclude African Americans, thereby limiting generalizability to this high-risk group.

Therefore, the rationale of this study is to test the feasibility of a novel habit formation (HF) intervention to facilitate frailty protective behaviors in prefrail African Americans ages 55 and older in a randomized control trial study. The HF intervention targets two main health behaviors: decrease sedentary time (ST) and improve dietary quality. The intervention consists of 12 treatment sessions over 12 weeks. In each session, an occupational therapist will deliver educational content, and use HF techniques and behavioral skills to facilitate frailty protective behaviors. Forty-eight prefrail African American adults will be randomized to the treatment or control group. The baseline evaluation will be conducted before randomization and the follow-up evaluation after the last treatment session. For the treatment group participants, we will further evaluation occupational activity performance/satisfaction and habit formation strength within treatment sessions.

The main goal of this study is to determine the feasibility of HF intervention among prefrail African American adults. The main hypothesis is: the SHAPE study will demonstrate good feasibility with (1) high recruitment rate (recruit 48 participants over 6 months), (2) treatment group participants will show preliminary efficacy in primary outcomes such as reducing sedentary time (measured by the ActivPal device) and increasing dietary quality score (measured by Healthy Eating Index \[HEI\]) at intervention completion compared to controls. The secondary hypothesis is: treatment group participants will demonstrate preliminary efficacy in secondary outcomes such as increased quality of life (measured by the Cardiovascular Health Study frailty criteria), reduced depressive symptoms (Geriatric Depression Short form), prefrailty reduction (The Fried's Frailty Criteria Index), increased lower extremity strength and balance (Short Physical Performance Battery), increased physical activity level (The Community Healthy Activities Model Program for Seniors), reduced waist circumference and weight at intervention completion compare to controls.

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)

Primary outcomes:
measure: Number of Participants Completed the Study
timeFrame: baseline to 6 months
measure: Seven-days Average Sedentary Time (Minutes/Day)
timeFrame: baseline to 14 weeks
measure: Healthy Eating Index Score
timeFrame: Baseline to 14th week
Secondary outcomes:
measure: The The World Health Organization Quality of Life- BREF
timeFrame: Baseline to 14th week
measure: Geriatric Depression Short Form (GDS)
timeFrame: Baseline to 14th week
measure: The Fried's Frailty Criteria Index
timeFrame: Baseline to 14th week
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline to 14th week
measure: The Community Healthy Activities Model Program for Seniors (CHAMPS)
timeFrame: Baseline to 14th week
measure: Waist Circumference
timeFrame: Baseline to14th weeks
measure: Weight
timeFrame: Baseline to 14 weeks
Other outcomes:
measure: The Canadian Occupational Performance Measure (Treatment Group Only) (COPM) for Treatment Group Only
timeFrame: Pre-test to week 13
measure: The Modified Self-reported Habit Index (Treatment Group Only)
timeFrame: baseline to two weeks
Locations:
city: Detroit
country: United States
facility: Eugene Applebaum College of Pharmacy and Health Sciences
state: Michigan
Study officials:
affiliation: Wayne State University
name: Heather Fritz, PhD
role: PRINCIPAL_INVESTIGATOR
References: