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Positive Psychology for Physical Activity Promotion (PPPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826173
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Brown University

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.


Condition or disease Intervention/treatment Phase
Obesity Physical Activity Behavioral: PPPA Behavioral: PA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Physical Activity Promotion Based on Positive Psychology: Development and Piloting of a Novel Intervention Approach
Actual Study Start Date : October 26, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: 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.

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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in Physical Activity [ Time Frame: Measured at baseline, week 4, week 7, and week 10. ]
    Total volume of MVPA (i.e., min of MVPA weighted by intensity) expressed in MET minutes will be determined by accelerometers (ActiGraph wGT3x-BT) worn during one-week periods.


Secondary Outcome Measures :
  1. Change in Positive and Negative Affect [ Time Frame: Survey will be administered at baseline, week 4, week 7, and week 10. ]
    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.

  2. Change in Optimism [ Time Frame: Survey will be administered at baseline, week 4, week 7, and week 10. ]
    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.

  3. 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.

  4. Change in Satisfaction with Life [ Time Frame: Survey will be administered at baseline, week 4, week 7, and week 10. ]
    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.

  5. Change in Social Support for Exercise [ Time Frame: Survey will be administered at baseline, week 4, week 7, and week 10. ]
    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.

  6. Change in Physical Activity Enjoyment [ Time Frame: Survey will be administered at baseline, week 4, week 7, and week 10. ]
    Measures enjoyment of physical activity. Scores range from 18 to 126, with higher scores reflecting greater enjoyment. Will be assessed as a putative mediator.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826173


Contacts
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Contact: Carley Vornlocher, BA 8635011 carley_vornlocher@brown.edu
Contact: Harold Lee, M.S.

Locations
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United States, Rhode Island
Brown University School of Public Health Recruiting
Providence, Rhode Island, United States, 02912
Contact: Carley Vornlocher, BA    401-863-6514    carley_vornlocher@brown.edu   
Sponsors and Collaborators
Brown University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David M Williams, PhD Brown University
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03826173    
Other Study ID Numbers: 1R21CA224609-01A1 ( U.S. NIH Grant/Contract )
1R21CA224609-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with interested parties after all of the initial study analyses and outcomes have been published.
Time Frame: Data will be made available 1 year after the completion of the study.
Access Criteria: All data access requests will be reviewed by a panel prior to acceptance.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brown University:
Positive Psychology
Affect