Trial Outcomes & Findings for Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial (NCT NCT03473886)

NCT ID: NCT03473886

Last Updated: 2020-05-12

Results Overview

Feasibility will be measured by examining the number of completed exercises.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

8 weeks of group sessions

Results posted on

2020-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Arm: PP-MI Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm: PP-MI n=8 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walkability.
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=8 Participants
Age, Categorical >=65 years	3 Participants n=8 Participants
Sex: Female, Male Female	8 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants
Race (NIH/OMB) White	7 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants
Physical Activity Adherence (Actigraph)	12.5 minutes/week STANDARD_DEVIATION 10.74 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Life Orientation Test- Revised Scores	11.7 score on a scale STANDARD_DEVIATION 2.8 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Positive and Negative Affect Schedule Scores	36.1 score on a scale STANDARD_DEVIATION 5.0 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
The Hospital Anxiety and Depression Scale - Anxiety Scores Scores	6.7 score on a scale STANDARD_DEVIATION 2.0 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
The Neighborhood Environment Walkability Scale-Abbreviated Scores	10.7 score on a scale STANDARD_DEVIATION 1.6 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Barriers to Being Active Quiz- Lack of Time Scores	2.0 score on a scale STANDARD_DEVIATION 2.5 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
The Medical Outcomes Study Short Form-12 Scores - Physical Composite Score	41.9 score on a scale STANDARD_DEVIATION 6.0 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
The Community Healthy Activities Model Program for Seniors Scores	14.6 minutes per week STANDARD_DEVIATION 7.7 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Behavioral Risk Factor Surveillance System Fruit and Vegetable Module - Fruit Category	1.2 fruits/day STANDARD_DEVIATION 1.5 • n=6 Participants • Although 8 participants were enrolled in the study, 6 participants completed this specific measure at the baseline assessment.
National Cancer Institute's Percentage Energy from Fat Screener Scores	3.9 number of times consumed per day STANDARD_DEVIATION 2.8 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
HADS-D Scores	4.6 score on a scale STANDARD_DEVIATION 2.9 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Barriers to Being Active Quiz Score- Social Influence	3.4 score on a scale STANDARD_DEVIATION 2.3 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Barriers to Being Active Quiz Score- Lack of Energy	1.3 score on a scale STANDARD_DEVIATION 2.6 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Barriers to Being Active Quiz Score- Lack of Willpower	5.9 score on a scale STANDARD_DEVIATION 0.7 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Barriers to Being Active Quiz Score - Fear of Injury	1.4 score on a scale STANDARD_DEVIATION 1.6 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Barriers to Being Active Quiz Score - Lack of Skill	2.7 score on a scale STANDARD_DEVIATION 0.6 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
Barriers to Being Active Quiz Score - Lack of Resources	2.7 score on a scale STANDARD_DEVIATION 2.8 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
SF-12 Scores - Mental Composite Score	48.2 score on a scale STANDARD_DEVIATION 8.2 • n=7 Participants • Although 8 participants were enrolled in the study, 7 participants completed this specific measure at the baseline assessment.
BRFSS- Vegetable Module	1.5 vegetable/day STANDARD_DEVIATION 0.8 • n=6 Participants • Although 8 participants were enrolled in the study, 6 participants completed this specific measure at the baseline assessment.

PRIMARY outcome

Timeframe: 8 weeks of group sessions

Feasibility will be measured by examining the number of completed exercises.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Number of PP-MI-Based Health Behavior Intervention Exercises Completed	7.0 Exercises completed Standard Deviation 0.5

PRIMARY outcome

Timeframe: 8 weeks of group sessions

Feasibility will be measured by examining the number of participants who wore Actigraphs with sufficient wear time both at baseline and at follow-up

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Number of Participants Completing Objective Physical Activity Measurement	7 Participants

SECONDARY outcome

Timeframe: 8 weeks

Acceptability of the intervention was assessed through participants' ratings of each PP and MI exercise. Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful;10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Acceptability of Intervention	8.1 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Change in physical activity level from baseline to 8 weeks

ActiGraph GT3X+ accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer to assess the feasibility of doing so and to ensure adequate capture of physical activity.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Physical Activity Adherence (Actigraph) Baseline	12.5 minutes/week Standard Deviation 10.74
Physical Activity Adherence (Actigraph) Week 8	40.9 minutes/week Standard Deviation 70.6

SECONDARY outcome

Timeframe: Change in dispositional optimism from baseline to 8 weeks

Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate higher levels of optimism.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Changes in Life Orientation Test- Revised Scores Baseline	11.7 score on a scale Standard Deviation 2.8
Changes in Life Orientation Test- Revised Scores 8 Weeks	10.1 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate higher levels of positive affect.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Changes in Positive and Negative Affect Schedule Scores Baseline	36.1 score on a scale Standard Deviation 5.0
Changes in Positive and Negative Affect Schedule Scores 8 Weeks	40.7 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range:0-21) Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate higher levels of anxiety.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Changes in The HADS-A Scores Baseline	6.7 score on a scale Standard Deviation 2.0
Changes in The HADS-A Scores 8 Weeks	5.6 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

Measure Description: NEWS is a 98-question instrument that assesses the perception of neighborhood design features related to physical activity. NEWS-A is an abbreviated version and will be used to measure residents' perceptions of neighborhood design related to physical activity, including places for walking and cycling, aesthetics, traffic hazards, and crime (Range: 16-64). Higher scores indicate greater perceived walkability.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Changes in The Neighborhood Environment Walkability Scale-Abbreviated Scores Baseline	10.7 score on a scale Standard Deviation 1.6
Changes in The Neighborhood Environment Walkability Scale-Abbreviated Scores 8 Weeks	10.8 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline and 8 weeks

The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of time" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Changes in Barriers to Being Active Quiz- Lack of Time Scores Baseline	2.0 score on a scale Standard Deviation 2.5
Changes in Barriers to Being Active Quiz- Lack of Time Scores 8 Weeks	2.3 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate higher level of health related QoL.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Changes in The Medical Outcomes Study Short Form-12 Scores - Physical Composite Score Baseline	41.9 score on a scale Standard Deviation 6.0
Changes in The Medical Outcomes Study Short Form-12 Scores - Physical Composite Score 8 Weeks	44.6 score on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

CHAMP is a self-report questionnaire that assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. It includes activities of various intensities (from light to vigorous) such as walking, running, hiking, swimming, bicycling, dancing, tennis, aerobics, yoga/tai chi, gardening, and housework. The activities are assessed in min/week.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Changes in The Community Healthy Activities Model Program for Seniors Scores Baseline	14.6 minutes per week Standard Deviation 7.7
Changes in The Community Healthy Activities Model Program for Seniors Scores 8 Weeks	23.1 minutes per week Standard Deviation 3.6

SECONDARY outcome

Timeframe: Change in # of fruits consumed/day from Baseline to 8 weeks

Measure Description: The CDC's BRFSS Fruit and Vegetable Module is a brief questionnaire about frequency of eating different types of fruits and vegetables. It assesses the frequency of consumption of 100% fruit juice, fruit, beans (legumes), dark green vegetables, orange vegetables, and other vegetables over the past month. The outcome measure is the number of fruits consumed per day.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=6 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module - Fruit Category Baseline	1.2 fruits/day Standard Deviation 1.5
Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module - Fruit Category 8 Weeks	1.1 fruits/day Standard Deviation 0.9

SECONDARY outcome

Timeframe: Change in number of times fat is consumed per day from Baseline to 8 weeks

The National Cancer Institute's Percentage Energy from Fat Screen is a brief questionnaire that estimates people's typical percentage of energy derived from eating common fat-containing foods, as fat content is related to metabolic syndrome progression. The questionnaire converts an individual's responses to an estimate of that individual's percentage energy from fat. Higher scores indicate higher fat consumption.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Changes in National Cancer Institute's Percentage Energy From Fat Screener Scores Baseline	3.9 # of times fat consumed/day Standard Deviation 2.8
Changes in National Cancer Institute's Percentage Energy From Fat Screener Scores 8 Weeks	3.4 # of times fat consumed/day Standard Deviation 1.1

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 8 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Change in HADS-D Scores Baseline	4.6 score on a scale Standard Deviation 2.9
Change in HADS-D Scores 8 Weeks	2.4 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "social influence" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Change in Barriers to Being Active Quiz Score- Social Influence Baseline	3.4 score on a scale Standard Deviation 2.3
Change in Barriers to Being Active Quiz Score- Social Influence 8 Weeks	2.3 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of energy" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Change in Barriers to Being Active Quiz Score- Lack of Energy Baseline	1.3 score on a scale Standard Deviation 2.6
Change in Barriers to Being Active Quiz Score- Lack of Energy 8 Weeks	1.9 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of will power" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Change in Barriers to Being Active Quiz Score- Lack of Willpower Baseline	5.9 score on a scale Standard Deviation 0.7
Change in Barriers to Being Active Quiz Score- Lack of Willpower 8 Weeks	2.1 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "fear of injury" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Change in Barriers to Being Active Quiz Score - Fear of Injury Baseline	1.4 score on a scale Standard Deviation 1.6
Change in Barriers to Being Active Quiz Score - Fear of Injury 8 Weeks	1.1 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of skill" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Change in Barriers to Being Active Quiz Score - Lack of Skill Baseline	2.7 score on a scale Standard Deviation 0.6
Change in Barriers to Being Active Quiz Score - Lack of Skill 8 Weeks	1.1 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63. Respondents rate the degree of activity interference on a 4-point scale, ranging from 0 = "very unlikely" to 3 = "very likely." This outcome explores "lack of resources" category (range of 0-9), and we calculated the change in score from baseline to 8 weeks.

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Change in Barriers to Being Active Quiz Score - Lack of Resources Baseline	2.7 score on a scale Standard Deviation 2.8
Change in Barriers to Being Active Quiz Score - Lack of Resources 8 Weeks	1.4 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Change in score from Baseline to 8 weeks

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=7 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Change in SF-12 Scores - Mental Composite Score Baseline	48.2 score on a scale Standard Deviation 8.2
Change in SF-12 Scores - Mental Composite Score 8 Weeks	54.2 score on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: Change in # of vegetables consumed/day from Baseline to 8 weeks

Outcome measures

Outcome measures
Measure	Intervention Arm: PP-MI n=6 Participants Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Change in BRFSS- Vegetable Module Baseline	1.5 vegetable/day Standard Deviation 0.8
Change in BRFSS- Vegetable Module 8 Weeks	1.9 vegetable/day Standard Deviation 0.7

Adverse Events

Intervention Arm: PP-MI

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention Arm: PP-MI n=8 participants at risk Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program. Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability.
Musculoskeletal and connective tissue disorders Pain after walking	12.5% 1/8 • Number of events 1 • 6 months Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."

Additional Information

Rachel A. Millstein

Massachusetts General Hospital

Phone: 617-724-2047

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place