Obesity, Physical Activity
Conditions
Keywords
Positive Psychology, Affect
Brief summary
This study is for physically inactive adults. Participants will be enrolled in the Positive Psychology and Physical Activity intervention designed to help them overcome barriers to physical activity, based on the principals of positive psychology. This will involve six weekly one-hour group-based sessions at a local YMCA with a trained group leader. In addition to the in-person sessions, there will be text messages sent to participants about physical activity that include positive psychology content.
Detailed description
The investigators propose to conduct a pilot study to test feasibility and proof-of-concept for a positive psychology intervention program to promote exercise among low-active overweight and obese adults. The program will be (a) a 6-week, group-based intervention, (b) delivered at local YMCAs, and (c) supplemented with text messaging. In an additive design, participants will be randomized in a 2:1 ratio to PPPA (n = 40) versus a control intervention (n = 20) including only the standard PA promotion components of the PPPA intervention (i.e., PA education, self-monitoring, and goal-setting), with equal frequency of staff contact and text message delivery. All participants will be followed for 3 months, and will receive a 3-month YMCA membership to equate access to PA facilities. As a secondary aim the investigators will examine effect sizes for PPPA versus the standard PA intervention on putative mediators that may underlie the efficacy of PPPA in improving PA outcomes, including positive and negative affect, optimism, happiness, life satisfaction, social support for PA, and PA enjoyment. The proposed research will set the stage for an RCT to test a novel PA promotion intervention that can be readily disseminated.
Interventions
BEHAVIORALPPPA
The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.
BEHAVIORALPA
The intervention will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions and instruction on how to gauge PA intensity, (c) goal-setting and self-monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period.
Sponsors
National Cancer Institute (NCI)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sedentary or low-active, (defined as \< 60 min/week of structured physical activity) * Able to receive and respond to a text message at the time of screening
Exclusion criteria
* History of coronary artery disease * History of stroke * History of uncontrolled hypertension * History of asthma * History of chronic obstructive pulmonary disease (COPD) * History of diabetes * History of osteoarthritis or orthopedic problems that limit physical activity * BMI greater than 40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Measured at baseline, mid-treatment (week 4), and post-treatment (week 7). | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week \[Time Frame: Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Optimism | Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up). | Life Orientation Test- Revised measures trait optimism. Scores range from 10 to 50, with higher scores reflecting greater optimism. Higher scores will reflect better outcomes of the intervention. |
| Change in Subjective Happiness | Survey will be administered at baseline, week 4, week 7, and week 10. | Measure of subjective happiness. Scores range from 4 to 28, with higher scores reflecting greater subjective happiness. Higher scores will reflect better outcomes of the intervention. |
| Change in Positive and Negative Affect | Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up). | The Positive and Negative Affect Scale measures changes in positive and negative affect. Both positive and negative affect sub-scales will be scored (scores range from 10 to 50 for each individual sub-scale), with higher scores on the positive affect scale and lower scores on the negative affect scale indicating a better outcome. |
| Change in Social Support for Exercise | Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up). | Measures perceived social support for regular exercise. Scores range from 13 to 65, with higher scores reflecting greater social support. Will be assessed as a putative mediator. |
| Change in Physical Activity Enjoyment | Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up). | Measures enjoyment of physical activity. Scores range from 18 to 126, with higher scores reflecting greater enjoyment. Will be assessed as a putative mediator. |
| Change in Satisfaction With Life | Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up). | Measures subjective well-being. Scores range from 5 to 35, with higher scores reflecting greater satisfaction with life and subjective well-being. Higher scores will reflect better outcomes of the intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Positive Psychology Phase 1 On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed. | 13 |
| Positive Psychology Phase 2 On a weekly basis, participants will engage in group-based intervention sessions that focus on personal strengths and the value of positive emotions and cognitions. Participants will receive daily text-messages addressing the content introduced during group sessions.
PPPA: The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed. | 30 |
| Physical Activity Promotion On a weekly basis, participants will engage in group-based intervention sessions that focus on the standard physical activity promotion components of the PPPA condition. Participants will receive daily text-messages addressing the content introduced during group sessions.
PA: The intervention will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions and instruction on how to gauge PA intensity, (c) goal-setting and self-monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. | 11 |
| Total | 54 |
Baseline characteristics
| Characteristic | Positive Psychology Phase 1 | Total | Physical Activity Promotion | Positive Psychology Phase 2 |
|---|---|---|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 12.8 | 40.9 years STANDARD_DEVIATION 14.3 | 37.3 years STANDARD_DEVIATION 15.2 | 40.1 years STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 13 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 40 Participants | 8 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 7 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 10 Participants | 34 Participants | 6 Participants | 18 Participants |
| Sex/Gender, Customized Female | 12 Participants | 37 Participants | 9 Participants | 16 Participants |
| Sex/Gender, Customized Male | 1 Participants | 16 Participants | 2 Participants | 13 Participants |
| Sex/Gender, Customized Prefer not to say | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 30 | 0 / 11 |
| other Total, other adverse events | 0 / 13 | 0 / 30 | 0 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 30 | 0 / 11 |
Outcome results
Primary
Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week
Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week \[Time Frame: Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).\]
Time frame: Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).
Population: Reporting of raw means. This is a feasibility study. It lacks adequate power for inferential analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology Phase 1 | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Post-treatment | 21.9 Minutes of physical activity | Standard Deviation 29.7 |
| Positive Psychology Phase 1 | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Baseline | 27.4 Minutes of physical activity | Standard Deviation 51.8 |
| Positive Psychology Phase 1 | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Mid-treatment | 54.5 Minutes of physical activity | Standard Deviation 50.2 |
| Positive Psychology Phase 2 | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Mid-treatment | 95.1 Minutes of physical activity | Standard Deviation 84.6 |
| Positive Psychology Phase 2 | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Post-treatment | 125.4 Minutes of physical activity | Standard Deviation 107.2 |
| Positive Psychology Phase 2 | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Baseline | 83.0 Minutes of physical activity | Standard Deviation 105.1 |
| Physical Activity Promotion | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Baseline | 88.4 Minutes of physical activity | Standard Deviation 77.6 |
| Physical Activity Promotion | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Post-treatment | 61.0 Minutes of physical activity | Standard Deviation 61.2 |
| Physical Activity Promotion | Change in Moderate-to-Vigorous Minutes of Physical Activity Per Week | Mid-treatment | 140.7 Minutes of physical activity | Standard Deviation 97.9 |
Secondary
Change in Optimism
Life Orientation Test- Revised measures trait optimism. Scores range from 10 to 50, with higher scores reflecting greater optimism. Higher scores will reflect better outcomes of the intervention.
Time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
Secondary
Change in Physical Activity Enjoyment
Measures enjoyment of physical activity. Scores range from 18 to 126, with higher scores reflecting greater enjoyment. Will be assessed as a putative mediator.
Time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
Secondary
Change in Positive and Negative Affect
The Positive and Negative Affect Scale measures changes in positive and negative affect. Both positive and negative affect sub-scales will be scored (scores range from 10 to 50 for each individual sub-scale), with higher scores on the positive affect scale and lower scores on the negative affect scale indicating a better outcome.
Time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
Secondary
Change in Satisfaction With Life
Measures subjective well-being. Scores range from 5 to 35, with higher scores reflecting greater satisfaction with life and subjective well-being. Higher scores will reflect better outcomes of the intervention.
Time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
Secondary
Change in Social Support for Exercise
Measures perceived social support for regular exercise. Scores range from 13 to 65, with higher scores reflecting greater social support. Will be assessed as a putative mediator.
Time frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
Secondary
Change in Subjective Happiness
Measure of subjective happiness. Scores range from 4 to 28, with higher scores reflecting greater subjective happiness. Higher scores will reflect better outcomes of the intervention.
Time frame: Survey will be administered at baseline, week 4, week 7, and week 10.