NCT04812756

Brief Summary

Rural women are more likely to be obese and have a higher risk for chronic disease than their non-rural counterparts. Inadequate physical activity (PA) at least in part contributes to this increased risk. Rural women face personal, social and environmental barriers to PA engagement. Interventions promoting walking among rural women have demonstrated success; however, few of these studies use text messaging to promote PA. Step-2-It was a pilot study to assess the feasibility, acceptability, and effectiveness of text-messaging combined with a pedometer to promote PA, specifically walking among English-speaking women, aged 40 and older, living in a rural, northwest Illinois county. There were two components to the 13-week, Step-2-It intervention: (i) participants used the pedometer to track and report their steps via text message daily; and (ii) participants received an informational or motivational text message daily. Enrolled participants completed baseline assessments, received pedometers and two types of automated text messages: motivational messages to encourage walking, and accountability messages to report pedometer steps. Participants engaged in 3, 6, 9, and 12-week follow-ups to download pedometer data, and completed post-intervention assessments at 12 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

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

Study Start

First participant enrolled

August 15, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2016

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 15, 2021

Last Update Submit

March 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical Activity levels

    mean steps per day measured using pedometer

    Change from baseline to end of intervention at 12 weeks

Secondary Outcomes (2)

  • Physical Activity Levels

    Change from baseline to end of intervention at 12 weeks

  • Body-weight

    Change from baseline to end of intervention at 12 weeks

Study Arms (1)

Texting intervention

EXPERIMENTAL

This is a single arm study in which all participants received a pedometer and text messages for the 12 week intervention period. Participants received a content message and a message requesting them to report the number of steps from their pedometer daily.

Behavioral: Step-2-It - text messaging program

Interventions

participants received a pedometer and text messages to motivate them to increase walking daily for a period of 12 weeks.

Texting intervention

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Age 40 and older
  • Reside in Stephenson County
  • Own a cell phone with ability to receive and send text messages
  • Unlimited texting plan
  • Able to give informed consent
  • Speak English

You may not qualify if:

  • Men
  • Women under 40 years of age
  • Reside outside Stephenson County
  • No cell phone or no texting ability
  • Non-English speaking
  • Unable to provide informed consent
  • Significant health conditions (including pyelonephritis, current treatment for cancer, other severe illness)
  • Active severe asthma
  • Current pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Lundeen EA, Park S, Pan L, O'Toole T, Matthews K, Blanck HM. Obesity Prevalence Among Adults Living in Metropolitan and Nonmetropolitan Counties - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Jun 15;67(23):653-658. doi: 10.15585/mmwr.mm6723a1.

    PMID: 29902166BACKGROUND
  • Whitfield GP, Carlson SA, Ussery EN, Fulton JE, Galuska DA, Petersen R. Trends in Meeting Physical Activity Guidelines Among Urban and Rural Dwelling Adults - United States, 2008-2017. MMWR Morb Mortal Wkly Rep. 2019 Jun 14;68(23):513-518. doi: 10.15585/mmwr.mm6823a1.

    PMID: 31194722BACKGROUND
  • Bassett DR Jr, Wyatt HR, Thompson H, Peters JC, Hill JO. Pedometer-measured physical activity and health behaviors in U.S. adults. Med Sci Sports Exerc. 2010 Oct;42(10):1819-25. doi: 10.1249/MSS.0b013e3181dc2e54.

    PMID: 20305579BACKGROUND
  • Trivedi T, Liu J, Probst J, Merchant A, Jhones S, Martin AB. Obesity and obesity-related behaviors among rural and urban adults in the USA. Rural Remote Health. 2015 Oct-Dec;15(4):3267. Epub 2015 Oct 13.

    PMID: 26458564BACKGROUND
  • Olsen JM. An integrative review of literature on the determinants of physical activity among rural women. Public Health Nurs. 2013 Jul;30(4):288-311. doi: 10.1111/phn.12023. Epub 2013 Jan 29.

    PMID: 23808855BACKGROUND
  • Murtagh EM, Nichols L, Mohammed MA, Holder R, Nevill AM, Murphy MH. The effect of walking on risk factors for cardiovascular disease: an updated systematic review and meta-analysis of randomised control trials. Prev Med. 2015 Mar;72:34-43. doi: 10.1016/j.ypmed.2014.12.041. Epub 2015 Jan 8.

    PMID: 25579505BACKGROUND
  • Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.

    PMID: 18029834BACKGROUND
  • Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health. 2015 Mar 18;36:393-415. doi: 10.1146/annurev-publhealth-031914-122855.

    PMID: 25785892BACKGROUND
  • Free C, Phillips G, Watson L, Galli L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis. PLoS Med. 2013;10(1):e1001363. doi: 10.1371/journal.pmed.1001363. Epub 2013 Jan 15.

    PMID: 23458994BACKGROUND
  • Khare MM, Zimmermann K, Lyons R, Locklin C, Gerber BS. Feasibility of promoting physical activity using mHEALTH technology in rural women: the step-2-it study. BMC Womens Health. 2021 Dec 16;21(1):415. doi: 10.1186/s12905-021-01561-5.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Manorama M Khare, PhD

    University of Illinois College of Medicine Rockford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single group prospective pre-post study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 24, 2021

Study Start

August 15, 2014

Primary Completion

February 15, 2015

Study Completion

June 15, 2016

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share