Positive Psychology for Physical Activity Promotion

Obesity Clinical Trial

— PPPA  

Official title:

Physical Activity Promotion Based on Positive Psychology: Development and Piloting of a Novel Intervention Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826173
• Other study ID #: 1R21CA224609-01A1
• Secondary ID: 1R21CA224609-01A
• Status: Completed
• Phase: N/A
• Start date: October 26, 2018
• Est. completion date: July 8, 2020

Study information

• Verified date: March 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 8, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).]	Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).
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.	Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
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.	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.	Survey will be administered at baseline, week 4, week 7, and week 10.
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.	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.	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.	Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).