NCT03575117

Brief Summary

This study is to assess how a theoretically guided mHealth communication informed by evidence of thoughts and affect about colorectal cancer can enhance how an existing mHealth (cell/mobile based text messaging health promotion) intervention increased physical activity in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started May 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

March 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

March 15, 2018

Last Update Submit

November 1, 2022

Conditions

Colorectal CancerSedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

  • Change in physical active level

    Change from physically active levels in METs at 6 weeks

    6 weeks

Secondary Outcomes (1)

  • Change in colorectal cancer risk and physical activity coherence

    6 weeks

Study Arms (2)

NCI HYT--GA + CSM--Be Well

EXPERIMENTAL

Participants who view the Common Sense Model (CSM) "Be Well" text and image communication will be invited to receive two sets of daily text messages: (1) one text message and one image per day and (2) National Cancer Institute (NCI) HealthyYouTXT-Get Active (HYT-GA) program that is delivered 2-5 times daily for 6 weeks. After baseline and at timepoint 2, participants will view a slide presentation with imagery and text related to colorectal cancer risk and sedentary lifestyle. The same messages will be delivered as a drip campaign alongside the NCI HYT-GA text messaging program.

Behavioral: Common-Sense Model (CSM) Be WellBehavioral: NCI HealthyYouTXT--Get Active (HYT--GA)

NCI HYT--GA + ACS usual messages

OTHER

Adapted American Cancer Society (ACS) informational messages about colorectal cancer risk and lifestyle will be invited to receive one set of daily text messages, NCI HealthyYouTXT-Get Active (HYT-GA) program that is delivered 2-5 times daily for 6 weeks. After baseline and at timepoint 2, participants will view an informational slide presentation that is based on adapted language from American Cancer Guidelines related to cancer prevention and physical activity (https://www.cancer.org/healthy/eat-healthy-get-active/acs-guidelines-nutrition-physical-activity-cancer-prevention.html).

Behavioral: ACS usual messagesBehavioral: NCI HealthyYouTXT--Get Active (HYT--GA)

Interventions

Common-Sense Model (CSM) Be WellBEHAVIORAL

Theoretically informed text messages and images that cover how physical activity is linked to decreasing colorectal cancer risk.

NCI HYT--GA + CSM--Be Well
ACS usual messagesBEHAVIORAL

Information distributed by the American Cancer Society as information on the link between physical activity and cancer risk (source: www.cancer.org)

NCI HYT--GA + ACS usual messages
NCI HealthyYouTXT--Get Active (HYT--GA)BEHAVIORAL

Text messaging program developed by National Cancer Society (NCI). It is a free SMS program that promotes physical activity.

NCI HYT--GA + ACS usual messagesNCI HYT--GA + CSM--Be Well

Eligibility Criteria

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

You may qualify if:

  • Open to all interested who are 18 years of age and older, all genders, all ethnic and/or racial identities, and regardless of health status.
  • Capacity to engage in physical active without medical and/or assisted supervision. During screening, this will be assessed by the Physical Activity Readiness (PAR-Q) survey. It confirms capacity to engage in physical activity that does not need to be medically/professionally supervised.
  • Has interest and ability to receive Short Message Service (SMS) text messages linked to a cell phone and access to the internet for information that is web based.
  • Individuals who report light/moderate physically active and sedentary lifestyles (\<6.0 METs). METs are the metabolic equivalents that measures the energy related to physical activity and/or sedentary behavior.
  • Interest in wearing a pedometer.

You may not qualify if:

  • Reports of vigorous levels of physical activity. Specifically, those who report \>6.0 METs. METs are the metabolic equivalents that measures the energy related to physical activity and/or sedentary behavior.
  • Those who report that a medical doctor has recommended anytime with the last 12 months that there be limited physical activity due to heart disease, pain, physical ailments, dizziness, loss of consciousness, bone/joint problems related to engaging in physical activity.
  • Those who report that a doctor recommended against engaging in supervised physical activity and/or moderate physical activity (such as walking, riding a bicycle, or mowing the lawn).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Merced

Merced, California, 95340, United States

Location

Related Publications (3)

  • Buhi, E. R., Trudnak, T. E., Martinasek, M. P., Oberne, A. B., Fuhrmann, H. J., & McDermott, R. J. (2013). Mobile phone-based behavioural interventions for health: A systematic review. Health Education Journal, 72, 564-583.

    BACKGROUND

  • Cameron LD, Jago L. Emotion regulation interventions: a common-sense model approach. Br J Health Psychol. 2008 May;13(Pt 2):215-21. doi: 10.1348/135910708X288800. Epub 2008 Feb 26.

    PMID: 18302809BACKGROUND

  • Durazo, A., & Cameron, L. D. (Manuscript in preparation). A review of cancer risk representations and affect: cancer beliefs and worry as predictors of protection motivation and behavior. Psychological Sciences. University of California, Merced.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsSedentary Behavior

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair of Psychological Sciences

Study Record Dates

First Submitted

March 15, 2018

First Posted

July 2, 2018

Study Start

May 1, 2018

Primary Completion

August 15, 2018

Study Completion

December 31, 2019

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)