Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study

NCT ID: NCT04140890

Last Updated: 2020-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2020-06-30

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.

Conditions

Frailty

Keywords

prefrail; habit; exercise; diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Treatment

Participants in the treatment group will be asked to meet with an occupational therapist in their home weekly over 12 weeks. Each session takes an hour. In the first session, the occupational therapist will introduce the program. In session 2, the therapist will discuss pain and pain management with the participant. In session 3-12, the therapist will help the participant to develop physical activity and healthy eating habits. In each session the participant will pick two healthy behaviors to turn them into a habit. The therapist will give the participant a workbook and teach the participant to track his/her progress. The focus of session 3-5 will be physical activity, and session 6-11 will be healthy eating. In the last session (session 12), the therapist will wrap up the program and help the participant to develop a maintenance plan.

Group Type: EXPERIMENTAL

Habit Formation

Intervention Type: BEHAVIORAL

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.

Control

Participants in the control group will receive newsletters focused on general healthy aging topics over 12 weeks. With the exception of two, 1-page handouts covering PA and dietary recommendations, the weekly content will not overlap with the treatment content. Within 4 days of mailing the newsletter, a trained research assistant (RA) will call the participant, verify receipt of the newsletter, and ask them if they have any questions about the materials. The phone call will last \~15 minutes. Control condition participants receive no further intervention.

Group Type: PLACEBO_COMPARATOR

Education

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Heather Fritz

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather Fritz, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Eugene Applebaum College of Pharmacy and Health Sciences

Detroit, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

065319B3E

Identifier Type: -

Identifier Source: org_study_id