ObesityPPPANCT03826173
Positive Psychology for Physical Activity Promotion
A study testing PPPA and PA in people with Obesity and Physical Activity, run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- PPPA and PA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2018to 8 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Physical Activity
- Being tested
- PPPA, PA
- Keywords
- Positive Psychology, Affect
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPPABehavioural
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.
PABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology | Experimental | 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. Receives: Behavioral: PPPA |
| Physical Activity Promotion | Active comparator | 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. Receives: Behavioral: PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline, mid-treatment (week 4), and post-treatment (week 7).
Secondary outcomes (6)
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.
Measured: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
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.
Measured: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
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.
Measured: Survey will be administered at baseline, week 4, week 7, and week 10.
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.
Measured: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
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.
Measured: 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
Measures enjoyment of physical activity. Scores range from 18 to 126, with higher scores reflecting greater enjoyment. Will be assessed as a putative mediator.
Measured: Survey will be administered at baseline, week 4 (mid-treatment), week 7 (post-treatment), and week 10 (one-month follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start26 Oct 2018
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David M Williams, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826173
- Sponsor's protocol ID
- 1R21CA224609-01A1
- Other IDs
- 1R21CA224609-01A1
- Acronym
- PPPA
- Status last verified
- Mar 2023
- First submitted
- 18 Sep 2018
- Last updated
- 4 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with interested parties after all of the initial study analyses and outcomes have been published.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Promotion Based on Positive Psychology: Development and Piloting of a Novel Intervention Approach
- ClinicalTrials.gov ID
- NCT03826173
- Acronym / sponsor ID
- PPPA / 1R21CA224609-01A1
- Conditions
- Obesity, Physical Activity
- Keywords
- Positive Psychology, Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Posted 4 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology | Experimental | Behavioral: PPPAOn 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. |
| Physical Activity Promotion | Active comparator | Behavioral: PAOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- History of coronary artery disease
- History of stroke
- History of uncontrolled hypertension
- History of asthma
- History of chronic obstructive pulmonary disease (COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPPAThe 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. | Behavioural | Positive Psychology |
| PAThe 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. | Behavioural | Physical Activity Promotion |
Primary outcome
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).]
6 secondary outcomes
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).
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).
Change in Subjective Happiness
Time frame: Survey will be administered at baseline, week 4, week 7, and week 10.
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).
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).
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with interested parties after all of the initial study analyses and outcomes have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Williams, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPPA and PA in people with Obesity and Physical Activity, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.