FrailtySHAPENCT04140890
Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study
A study testing Habit Formation and Education in people with Frailty, run by Wayne State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Habit Formation and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Community-dwelling
- Prefrail (evaluated by the Frailty scale)
- Self-identify as African Americans.
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Eugene Applebaum College of Pharmacy and Health Sciences
Detroit, Michigan, 48201
About this study
Official title: Supporting Habit Formation to Attenuate Prefrailty in Elders: a Pilot Study
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.
Read the 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
- Being tested
- Habit Formation, Education
- Keywords
- prefrail, habit, exercise, diet
- Medical subject headings
- Frailty, Habits, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habit FormationBehavioural
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.
EducationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Behavioral: Habit Formation |
| Control | Placebo comparator | 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completed the Study
The number of participants completed the intervention and post-test.
Measured: baseline to 6 months
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.
Measured: baseline to 14 weeks
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.
Measured: Baseline to 14th week
Secondary outcomes (7)
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.
Measured: Baseline to 14th week
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.
Measured: Baseline to 14th week
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).
Measured: Baseline to 14th week
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).
Measured: Baseline to 14th week
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.
Measured: Baseline to 14th week
Waist Circumference
Waist circumference in inches is measured by the Gulick II tape measure.
Measured: Baseline to14th weeks
Weight
Weight (pounds) is measured by medical weight scales.
Measured: Baseline to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start30 Sep 2019
- Primary completion30 Mar 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment group will receive healthy habit intervention, and the control group will receive attention control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Fritz, Wayne State University
- Investigators
- Heather Fritz, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140890
- Sponsor's protocol ID
- 065319B3E
- Acronym
- SHAPE
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2019
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Habit Formation to Attenuate Prefrailty in Elders: a Pilot Study
- ClinicalTrials.gov ID
- NCT04140890
- Acronym / sponsor ID
- SHAPE / 065319B3E
- Conditions
- Frailty
- Keywords
- prefrail, habit, exercise, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Posted 23 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The treatment group will receive healthy habit intervention, and the control group will receive attention control.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Habit FormationParticipants 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. |
| Control | Placebo comparator | Behavioral: EducationParticipants 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking
- Community-dwelling
- Prefrail (evaluated by the Frailty scale)
- Self-identify as African Americans.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Habit FormationTreatment 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. | Behavioural | Treatment |
| EducationIn 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. | Behavioural | Control |
Primary outcome
Number of Participants Completed the Study
Time frame: baseline to 6 months
The number of participants completed the intervention and post-test.
Seven-days Average Sedentary Time (Minutes/Day)
Time frame: baseline to 14 weeks
A physical activity tracking system activPAL™. The ActivPal sensor will be attached to participants' thigh for 7 consecutive days.
Healthy Eating Index Score
Time frame: Baseline to 14th week
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.
7 secondary outcomes
The The World Health Organization Quality of Life- BREF
Time frame: Baseline to 14th week
Geriatric Depression Short Form (GDS)
Time frame: Baseline to 14th week
The Fried's Frailty Criteria Index
Time frame: Baseline to 14th week
Short Physical Performance Battery (SPPB)
Time frame: Baseline to 14th week
The Community Healthy Activities Model Program for Seniors (CHAMPS)
Time frame: Baseline to 14th week
Waist Circumference
Time frame: Baseline to14th weeks
Weight
Time frame: Baseline to 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Fritz, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habit Formation and Education in people with Frailty, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Completed the Study (time frame: baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.