Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study

Frailty Clinical Trial

— SHAPE  

Official title:

Supporting Habit Formation to Attenuate Prefrailty in Elders: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04140890
• Other study ID #: 065319B3E
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• Habit Formation
Treatment sessions consist of 12 weekly health coaching sessions at participants' home. During the intervention period, an occupational therapist will help the participant to commit to developing new simple habits (dietary habits or physical activity habits) in each 60-minute session.
• Education
In the education group, participants will receive newsletters containing general healthy aging materials over 12 weeks. A trained research assistant will call participants to verify receipt of the newsletter, and answer their questions about the materials. Each phone call will last ~15 minutes.

Locations

Country	Name	City	State
United States	Eugene Applebaum College of Pharmacy and Health Sciences	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Canadian Occupational Performance Measure (Treatment Group Only) (COPM) for Treatment Group Only	The COPM is self-perception of occupational performance in the areas of self-care, productivity and leisure. The COPM is administered using a semi-structured interview in which the client identifies significant issues in daily activities which are causing difficulty. The importance of each activity, as perceived by the client, is first rated on a 10-point scale ranging from 1 (not important at all) to 10 (extremely important). In the next step the client selects the five most important activities, which are then rated on a 10-point scale for performance, ranging from 1 (not at all able) to 10 (able to perform extremely well), and for satisfaction, ranging from 1 (not at all satisfied) to 10 (extremely satisfied). Increased performance/satisfaction score from follow-up to baseline represents improved performance/satisfaction.	Pre-test to week 13
Other	The Modified Self-reported Habit Index (Treatment Group Only)	The modified self-reported habit index (SRHI) is a 4-item assessment that measures habit strength, frequency, relevance to self-identity, and automaticity. Items are self-rated with a seven-point Likert scale (1=strongly disagree, 7= strongly agree). The average score of the 4 items range from 1 to 7 indicates habit formation, where higher scores indicate stronger the habit is. During 9 treatment sessions (the 3,4,5,6,7,8,9,10,11 treatment sessions), 2-4 habits regarding physical activity and diet will be assessed individually with the modified SRHI. Post-test of each habit will be assessed again after 2 weeks. We calculated the average score of the index of each habit.	baseline to two weeks
Primary	Number of Participants Completed the Study	The number of participants completed the intervention and post-test.	baseline to 6 months
Primary	Seven-days Average Sedentary Time (Minutes/Day)	A physical activity tracking system activPAL™. The ActivPal sensor will be attached to participants' thigh for 7 consecutive days.	baseline to 14 weeks
Primary	Healthy Eating Index Score	ASA 24 is a web-based tool for participants to recall their diet on a daily basis. The HEI score is calculated by a standard SAS code provided by ASA 24 website to evaluated the content of participants' dietary recalls. Scores range from 1-100 with higher scores indicating better quality diet.	Baseline to 14th week
Secondary	The The World Health Organization Quality of Life- BREF	The World Health Organization Quality of Life- BREF (WHOQOL-BREF) is a 26 item questionnaire, which measures the four broad domains of quality of life(QOL): physical health, psychological health, social relationships, and environment. Items are rated on a 5-point Likert scale (low score of 1 to a high score of 5) to determine a raw item score. Subsequently, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. To compare the results with other studies, the mean scores per domain is then converted into transformed scores based on the WHOQOL-BREF scoring manual. The transformed scores per domain range from 0 to 100, where a higher score indicates better QOL.	Baseline to 14th week
Secondary	Geriatric Depression Short Form (GDS)	The Geriatric Depression Short form (GDS) is a 15-item measure in which participants self-report depressive feelings (scoring range from 0-15). A higher score indicates more depressive symptoms.	Baseline to 14th week
Secondary	The Fried's Frailty Criteria Index	The Fried's Frailty index is a 5-item measure indicating the number of frailty symptoms (scale range from 0-5). A higher score indicates more frailty symptoms (worse outcomes).	Baseline to 14th week
Secondary	Short Physical Performance Battery (SPPB)	The Short Physical Performance Battery-Balance Test (SPPB) assess balance and mobility with three subtests (score range: 0 to 4): standing balance, three-meter gait speed, and five repetitions of sit-to-stand motion. Total score are sums of subtest scores ranging from 0 (worst performance) to 12 (best performance).	Baseline to 14th week
Secondary	The Community Healthy Activities Model Program for Seniors (CHAMPS)	The CHAMPS is 41-item, self-administered instrument assessing physical activity patterns among older adults. Each item asks for the frequency and duration of an activity that older adults do in the past week. Energy expenditure (Kcal/week) of physical activities is calculated from the items.	Baseline to 14th week
Secondary	Waist Circumference	Waist circumference in inches is measured by the Gulick II tape measure.	Baseline to14th weeks
Secondary	Weight	Weight (pounds) is measured by medical weight scales.	Baseline to 14 weeks