- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03826173
Positive Psychology for Physical Activity Promotion (PPPA)
Physical Activity Promotion Based on Positive Psychology: Development and Piloting of a Novel Intervention Approach
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University School of Public Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Positive Psychology
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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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).]
|
Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Subjective Happiness
Time Frame: 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.
|
Survey will be administered at baseline, week 4, week 7, and week 10.
|
|
Change in Positive and Negative Affect
Time Frame: 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.
|
Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
|
|
Change in Optimism
Time Frame: 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.
|
Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
|
|
Change in Satisfaction With Life
Time Frame: 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.
|
Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
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Change in Social Support for Exercise
Time Frame: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
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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.
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Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
|
|
Change in Physical Activity Enjoyment
Time Frame: 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.
|
Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David M Williams, PhD, Brown University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R21CA224609-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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