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Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study (SHAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04140890
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : October 28, 2019
Information provided by (Responsible Party):
Heather Fritz, Wayne State University

Tracking Information
First Submitted Date  ICMJE October 21, 2019
First Posted Date  ICMJE October 28, 2019
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE September 30, 2019
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • Recruitment rates are documented by raters' logs [ Time Frame: 6 months ]
    Research team members who call potential participants will document recruitment rate over the 6 month recruitment period in raters' logs.
  • Seven-days average sedentary time (minutes/day) [ Time Frame: 13 weeks ]
    A physical activity tracking system activPAL™ will be used to track participants' sedentary time. ActivPal sensor will be attached to participants' thigh to track body position to determine sedentary time in minutes.
  • Healthy eating index score generated from the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool [ Time Frame: 13 weeks ]
    ASA 24 is a web-based tool for participants to recall their diet on a daily basis. The healthy eating score will be calculated from two ASA 24 recall. The healthy eating index assesses compliance with the Dietary Guidelines for Americans.Higher scores indicate higher compliance and healthier diet.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • The The World Health Organization Quality of Life- BREF [ Time Frame: 13 weeks ]
    The The World Health Organization Quality of Life- BREF (WHOQOL-BREF) is a 26 item assessment to in which participants self-report their quality of file. A transformed score (0-100) will be calculated from raw score. Higher transformed scores indicates better quality of life.
  • Geriatric Depression Short form (GDS) [ Time Frame: 13 weeks ]
    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.
  • The Fried's Frailty Criteria Index [ Time Frame: 13 weeks ]
    The Fried's Frailty index is a 5-item measure indicating the number of frailty symptoms (range from from 0-5).
  • Short Physical Performance Battery (SPPB) [ Time Frame: 13 weeks ]
    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).
  • The Community Healthy Activities Model Program for Seniors (CHAMPS) [ Time Frame: 13 weeks ]
    The CHAMPS is 41-item, self-administered instrument to assess 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.
  • Waist circumference [ Time Frame: 13 weeks ]
    Waist circumference in inches is measured by the Gulick II tape measure.
  • Weight [ Time Frame: 13 weeks ]
    Weight (pounds) is measured by medical weight scales.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 23, 2019)
  • The Canadian Occupational Performance Measure (Treatment group only) (COPM) for treatment group only [ Time Frame: 13 weeks ]
    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.
  • The modified self-reported habit index (Treatment group only) [ Time Frame: 2 weeks ]
    The modified self-reported habit index (SRHI) is a 4-item assessment assesses 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). Total score ranges from 4 to 28, 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.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study
Official Title  ICMJE Supporting Habit Formation to Attenuate Prefrailty in Elders: a Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The treatment group will receive healthy habit intervention, and the control group will receive attention control.
Masking: Single (Outcomes Assessor)
Masking Description:
Outcome assessors will be masked.
Primary Purpose: Prevention
Condition  ICMJE Frailty
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Habit Formation
  • Placebo Comparator: 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.
    Intervention: Behavioral: Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heather Fritz, PhD 313-577-9499
Contact: Yi-Ling Hu, PhD 313-993-9932
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04140890
Other Study ID Numbers  ICMJE 065319B3E
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heather Fritz, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heather Fritz, PhD Wayne State University
PRS Account Wayne State University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP