NCT04711512

Brief Summary

The purpose of this study is to test the short-term effects of physical activity promotion messages designed for midlife adults. These messages are designed to provide information and motivation for physical activity by engaging key social processes, such as social comparison (i.e., self-evaluations relative to others).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

January 7, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 8, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

January 7, 2021

Last Update Submit

April 27, 2022

Conditions

ExerciseSedentary BehaviorMotivation

Outcome Measures

Primary Outcomes (3)

  • Number of steps

    Assessed via pedometer

    up to 24 weeks

  • Number of minutes in moderate-to-vigorous activity

    Assessed via pedometer

    up to 24 weeks

  • Number of minutes spent sedentary

    Assessed via pedometer

    up to 24 weeks

Secondary Outcomes (1)

  • Motivation for physical activity

    up to 24 weeks

Study Arms (1)

Single Arm (All Participants)

Within this arm, participants are randomized to one of the interventions described below at each of 4 times per day.

Behavioral: Encouragement/SupportBehavioral: Social Comparison

Interventions

Encouragement/SupportBEHAVIORAL

Messages that focus on improving self-efficacy and motivation for physical activity

Single Arm (All Participants)
Social ComparisonBEHAVIORAL

Messages that provide exposure to another person's physical activity engagement data (for comparison)

Single Arm (All Participants)

Eligibility Criteria

Age40 Years - 60 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-identification as a woman, man, nonbinary, or other
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults in midlife with elevated risk for cardiovascular disease (as defined by one or more of the following: smoking, diagnoses of obesity. prediabetes/type 2 diabetes, prehypertension/ hypertension, high cholesterol, or metabolic syndrome)

You may qualify if:

  • Adult age 40-60 years old
  • Sedentary (\<150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity a week)
  • One or more cardiovascular risk conditions (i.e., smoking, diagnoses of obesity. prediabetes/type 2 diabetes, prehypertension/hypertension, high cholesterol, metabolic syndrome)
  • English language fluency
  • Own a personal smartphone
  • Have no medical or psychiatric contraindications to changing their physical activity (e.g., current injury, substance use disorder)

You may not qualify if:

  • Not an adult age 40-60 years
  • Not sedentary (≥150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity a week)
  • No health conditions listed above (smoking, diagnoses of obesity, prediabetes/type 2 diabetes, prehypertension/hypertension, high cholesterol, metabolic syndrome)
  • No English language fluency
  • Does not own a personal smartphone
  • Has medical or psychiatric contraindications to changing their physical activity (e.g., current injury, substance use disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowan University

Glassboro, New Jersey, 08028, United States

Location

Related Publications (1)

  • Arigo D, Schumacher LM, Baga K, Mogle JA. Digital, Social Micro-Interventions to Promote Physical Activity Among Midlife Adults With Elevated Cardiovascular Risk: An Ambulatory Feasibility Study With Momentary Randomization. Ann Behav Med. 2024 Nov 16;58(12):845-856. doi: 10.1093/abm/kaae058.

    PMID: 39454044DERIVED

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Danielle Arigo

    Rowan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 15, 2021

Study Start

April 8, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)