Trial Outcomes & Findings for Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study (NCT NCT04140890)

NCT ID: NCT04140890

Last Updated: 2020-11-23

Results Overview

The number of participants completed the intervention and post-test.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: baseline to 6 months
• Results posted on: 2020-11-23

Participant Flow

Participants were recruited from September 2019 to March 2020 in metropolitan Detroit, Michigan.

Drop out due to unable to comply to study procedure (n=4) Disenroll due to COVID-19 outbreak (n=5)

Participant milestones

Measure	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.	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.
Overall Study STARTED	9	12
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study

Baseline characteristics by cohort

Measure	Treatment n=9 Participants 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.	Control n=11 Participants 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.	Total n=20 Participants Total of all reporting groups
Age, Continuous	72.1 years STANDARD_DEVIATION 12.4 • n=5 Participants	74.6 years STANDARD_DEVIATION 8.1 • n=7 Participants	73.5 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 6 months

Population: Contacted 30 participants before the intervention started.

The number of participants completed the intervention and post-test.

Outcome measures

Measure	Control n=15 Participants 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.	Treatment n=15 Participants 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.
Number of Participants Completed the Study	9 Participants	11 Participants

PRIMARY outcome

Timeframe: baseline to 14 weeks

Population: One treatment group participant was excluded because the participant did not complete the full assessment at post-test.

A physical activity tracking system activPAL™. The ActivPal sensor will be attached to participants' thigh for 7 consecutive days.

Outcome measures

Measure	Control n=8 Participants 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.	Treatment n=11 Participants 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.
Seven-days Average Sedentary Time (Minutes/Day) Post-test	565 min/day Standard Deviation 129.7	582.3 min/day Standard Deviation 191
Seven-days Average Sedentary Time (Minutes/Day) Pre-test	551.9 min/day Standard Deviation 128.1	555.5 min/day Standard Deviation 166.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=9 Participants 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.	Treatment n=11 Participants 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.
Healthy Eating Index Score Healthy eating index score at pre-test	44.4 score on a scale Standard Deviation 17.4	46.7 score on a scale Standard Deviation 11.9
Healthy Eating Index Score Healthy eating index score at post-test	46.9 score on a scale Standard Deviation 14.3	46.9 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline to 14th week

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.

Outcome measures

Measure	Control n=9 Participants 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.	Treatment n=11 Participants 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.
The The World Health Organization Quality of Life- BREF Environment at pre-test	73.6 score on a scale Standard Deviation 19.1	79.8 score on a scale Standard Deviation 11.6
The The World Health Organization Quality of Life- BREF Physical at pre-test	78.1 score on a scale Standard Deviation 18.5	72.7 score on a scale Standard Deviation 12.5
The The World Health Organization Quality of Life- BREF Physical at post-test	78.6 score on a scale Standard Deviation 16.6	73.1 score on a scale Standard Deviation 15.8
The The World Health Organization Quality of Life- BREF Psychological at pre-test	72.2 score on a scale Standard Deviation 14.9	83.3 score on a scale Standard Deviation 8.9
The The World Health Organization Quality of Life- BREF Psychological at post-test	74.1 score on a scale Standard Deviation 20	81.1 score on a scale Standard Deviation 8.2
The The World Health Organization Quality of Life- BREF Social Relationship at pre-test	63.9 score on a scale Standard Deviation 15.6	82.6 score on a scale Standard Deviation 8.7
The The World Health Organization Quality of Life- BREF Social Relationship at post-test	63.9 score on a scale Standard Deviation 22.1	73.5 score on a scale Standard Deviation 14.4
The The World Health Organization Quality of Life- BREF Environment at post-test	72.6 score on a scale Standard Deviation 23.8	83 score on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: Baseline to 14th week

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.

Outcome measures

Measure	Control n=9 Participants 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.	Treatment n=11 Participants 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.
Geriatric Depression Short Form (GDS) Pre-test	2.3 score on a scale Standard Deviation 2.5	1.3 score on a scale Standard Deviation 0.8
Geriatric Depression Short Form (GDS) Post-test	3.9 score on a scale Standard Deviation 4.2	1.6 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline to 14th week

Population: One treatment group participant was excluded because the participant did not complete the full assessment at post-test.

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).

Outcome measures

Measure	Control n=8 Participants 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.	Treatment n=11 Participants 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.
The Fried's Frailty Criteria Index Pre-test	1.9 units on a scale Standard Deviation 1.5	0.9 units on a scale Standard Deviation 1
The Fried's Frailty Criteria Index Post-test	1.6 units on a scale Standard Deviation 1.4	0.9 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline to 14th week

Population: One treatment group participant was excluded because the participant did not complete the full assessment at post-test.

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).

Outcome measures

Measure	Control n=8 Participants 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.	Treatment n=11 Participants 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.
Short Physical Performance Battery (SPPB) Pre-test	6.8 score on a scale Standard Deviation 2.8	7.1 score on a scale Standard Deviation 2.4
Short Physical Performance Battery (SPPB) Post-test	7.6 score on a scale Standard Deviation 2.2	7.3 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline to 14th week

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.

Outcome measures

Measure	Control n=9 Participants 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.	Treatment n=11 Participants 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.
The Community Healthy Activities Model Program for Seniors (CHAMPS) Pre-test	1915.6 kcal/week Standard Deviation 2063.5	2014.4 kcal/week Standard Deviation 1912.3
The Community Healthy Activities Model Program for Seniors (CHAMPS) Post-test	2694.5 kcal/week Standard Deviation 1761.1	1838.1 kcal/week Standard Deviation 781.3

SECONDARY outcome

Timeframe: Baseline to14th weeks

Population: One treatment group participant was excluded because the participant did not complete the full assessment at post-test.

Waist circumference in inches is measured by the Gulick II tape measure.

Outcome measures

Measure	Control n=8 Participants 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.	Treatment n=11 Participants 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.
Waist Circumference Pre-test	40.8 Inches Standard Deviation 3.2	39.7 Inches Standard Deviation 4.8
Waist Circumference Post-test	40.1 Inches Standard Deviation 4.5	40 Inches Standard Deviation 4.4

SECONDARY outcome

Timeframe: Baseline to 14 weeks

Population: One treatment group participant was excluded because the participant did not complete the full assessment at post-test.

Weight (pounds) is measured by medical weight scales.

Outcome measures

Measure	Control n=8 Participants 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.	Treatment n=11 Participants 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.
Weight Pre-test	172 pounds Standard Deviation 34.3	177.8 pounds Standard Deviation 37.7
Weight Post-test	172.5 pounds Standard Deviation 32.3	179.5 pounds Standard Deviation 35.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-test to week 13

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.

Outcome measures

Measure	Control n=9 Participants 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.	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.
The Canadian Occupational Performance Measure (Treatment Group Only) (COPM) for Treatment Group Only Performance at pre-test	4.6 score on a scale Standard Deviation 2.0	—
The Canadian Occupational Performance Measure (Treatment Group Only) (COPM) for Treatment Group Only Performance at post-test	5.3 score on a scale Standard Deviation 2.3	—
The Canadian Occupational Performance Measure (Treatment Group Only) (COPM) for Treatment Group Only Satisfaction at pre-test	3.6 score on a scale Standard Deviation 2.4	—
The Canadian Occupational Performance Measure (Treatment Group Only) (COPM) for Treatment Group Only Satisfaction at post-test	5.7 score on a scale Standard Deviation 2.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to two weeks

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.

Outcome measures

Measure	Control n=9 Participants 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.	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.
The Modified Self-reported Habit Index (Treatment Group Only) Pre-test	1.89 score on a scale Standard Deviation 0.87	—
The Modified Self-reported Habit Index (Treatment Group Only) Post-test	4.69 score on a scale Standard Deviation 1.24	—

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yi-Ling Hu

Wayne State University

Phone: 3142039991

Email: ha1124@wayne.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place