NCT01940016

Brief Summary

This randomized clinical trial studies the feasibility of tailored physical activity intervention that is administered using Interactive Voice Response technology and cell phones. Interactive voice response and health coach support may motivate overweight postmenopausal women to stick to their exercise regimen to reduce the risk of getting breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable healthy

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

Study Start

First participant enrolled

April 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

2.6 years

First QC Date

July 13, 2013

Last Update Submit

June 26, 2020

Conditions

HealthyObesityPostmenopausal

Keywords

Feasibility studyInteractive voice response system (IVR)health coachno evidence of disease

Outcome Measures

Primary Outcomes (1)

  • Change in time taken to complete a one mile walk.

    12 weeks

Secondary Outcomes (3)

  • Changes in anthropometrics, psychometrics and the benefits of a health coach.

    12 weeks

  • Weekly effectiveness (satisfaction, convenience, ease of operation) of all the materials and processes as assessed by questionnaires.

    12 weeks

  • If the self-reported steps per day, derived from daily activity logs, relates to the change in performance on the 1-mile walk test between baseline and end of study.

    12 Week

Study Arms (2)

Arm I (health coach)

EXPERIMENTAL

Participants participate in a 12-week physical activity intervention (walking program)and receive health mail messages via IVR system and from a health coach. Participants in this arm of the study, interacted with the IVR system and had the option of interacting with the health coach.

Behavioral: communication interventionBehavioral: exercise intervention

Arm II (no coach condition)

ACTIVE COMPARATOR

Participants participate in a 12-week physical activity intervention (walking program)and receive health mail messages via IVR system. Participants in this arm of the study only interacted with the IVR system.

Behavioral: exercise intervention

Interventions

communication interventionBEHAVIORAL

Participants participate in a 12-week physical activity intervention (walking program)and receive health mail messages via IVR system and had the option of communicating with a health coach.

Arm I (health coach)
exercise interventionBEHAVIORAL

Participants participate in a 12-week physical activity intervention administered using an IVR system.

Arm I (health coach)Arm II (no coach condition)

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Present a letter/documentation from a primary physician stating that they can participate in a physical activity program that will require walking up to 10,000 steps per day
  • Have a body mass index (BMI) between 25 and 40 kg/m\^2 (inclusive)
  • Be postmenopausal, defined as no period for 12 months if over age 55, or no period for 12 months; also, women who have had their ovaries removed will be considered as postmenopausal
  • Willing to participate in a wellness program that lasts 12 weeks and involves walking for at least 30 minutes a day on most days
  • Has access to a cell phone during the 12-week intervention
  • Functional knowledge of English (ability to both read and write)

You may not qualify if:

  • Taking hormone replacement therapy within 3 months of enrollment
  • Taking Tamoxifen or Raloxifene within 3 months of enrollment
  • Enrolled in a weight management program, such as Weight Watchers
  • Engaged in regular, planned walking of at least 30 minutes a day
  • Previous history of breast cancer
  • Premenopausal
  • Age \> 75 years, to minimize co-morbidities
  • Cannot walk one mile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Electra Paskett, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director for Population Sciences, Comprehensive Cancer Center, Ohio State University; Marion N. Rowley Professor of Cancer Research and Director, Division of Cancer Prevention and Control

Study Record Dates

First Submitted

July 13, 2013

First Posted

September 11, 2013

Study Start

April 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

June 30, 2020

Record last verified: 2020-06

Locations

US(1)