NCT03826173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 26, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

April 4, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

September 18, 2018

Results QC Date

January 12, 2023

Last Update Submit

March 9, 2023

Conditions

Keywords

Positive PsychologyAffect

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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).

  • Change in Optimism

    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

    Survey will be administered at baseline, week 4, week 7, and week 10.

  • 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).

  • 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).

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: PA

Interventions

PPPABEHAVIORAL

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.

Positive Psychology
PABEHAVIORAL

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.

Physical Activity Promotion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
David M Williams
Organization
Brown University School of Public Health

Study Officials

  • David M Williams, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

February 1, 2019

Study Start

October 26, 2018

Primary Completion

July 8, 2020

Study Completion

July 8, 2020

Last Updated

April 4, 2023

Results First Posted

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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.

Locations