NCT04457128

Brief Summary

The goal of this study is to adapt an evidence-based sedentary behavior reduction intervention for men and women living in Alabama and determine its feasibility, acceptance, and limited efficacy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable cancer

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

November 9, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

April 3, 2020

Last Update Submit

November 5, 2020

Conditions

CancerAgingComorbidities and Coexisting Conditions

Keywords

physical activityecological momentary assessmenthealth-related quality of lifeJust-in-time adaptive intervention

Outcome Measures

Primary Outcomes (2)

  • Usage

    To percentage of time participants were complying with the study protocol

    16 weeks

  • The Usage, Satisfaction, Ease of use Questionnaire

    Questionnaire that assesses usage, satisfaction, and ease of use of technology. Each subscale has a maximum score of 20, with higher scores indicating a better outcome.

    16 weeks

Secondary Outcomes (2)

  • Change in sedentary time

    Week 0 and Week 16

  • Change in light-intensity physical activity

    Week 0 and Week 16

Study Arms (4)

Secular Image

EXPERIMENTAL

Secular Image

Behavioral: Just-in-Time Adaptive Intervention

Non-secular image

EXPERIMENTAL

non-secular images

Behavioral: Just-in-Time Adaptive Intervention

Secular message

EXPERIMENTAL

secular messages

Behavioral: Just-in-Time Adaptive Intervention

Non-secular message

EXPERIMENTAL

non-secular messages

Behavioral: Just-in-Time Adaptive Intervention

Interventions

Just-in-Time Adaptive InterventionBEHAVIORAL

Randomized factorial design

Non-secular imageNon-secular messageSecular ImageSecular message

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 50 to 75 years old at study enrollment;
  • Currently living in Alabama;
  • Community-dwelling (i.e., not living in an assisted living facility or nursing home);
  • Having access to the internet and a smart phone;
  • Able to perform light-intensity physical activity (i.e., walking);
  • English speaking;
  • Willing to consent to study procedure.

You may not qualify if:

  • Reporting more than 60 minutes of purposeful physical activity per week;
  • Have an unstable mental condition that prevention study activities. Determined by the Physician Health questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Raheem Paxton, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raheem Paxton, PhD

CONTACT

205-348-6857rpaxton@ua.edu

Monica Anderson-Herzog, PhD

CONTACT

205 348 1667Anderson@cs.ua.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Micro-randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

July 7, 2020

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

August 31, 2021

Last Updated

November 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

No at this time