HealthyBePHITNCT01940016
Communication & Peer Support Effects on Physical Activity in Overweight Postmenopausal Women
A study testing communication intervention and exercise intervention in people with Healthy and Obesity, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies the feasibility of tailored physical activity intervention that is administered using Interactive Voice Response technology and cell phones. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obesity, Postmenopausal
- What is being tested?
- communication intervention and exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2007to 1 Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: A Feasibility Study on the Effects of Tailored Communication and Health Coach Support on Physical Activity in Overweight Postmenopausal Women: BePHIT
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To design, develop and test the feasibility of implementing a physical activity intervention using tailored communication and Interactive Voice Response (IVR) technology. We will to address four basic questions to accomplish this aim:
- Among overweight, postmenopausal women, who pass the screening criteria, what is the percentage of women who are willing to participate in a 12-week physical activity intervention that includes two 1-mile walk tests and two visits to the General Clinical Research Center (GCRC)?
- After beginning the study, what proportion of women use the cell phone and land line at least 5 days a week to get a physical activity intervention message?
- How many participants are enrolled and participating in the study at the end of the 12-week intervention period?
- On average, how many steps per day do participants walk? How many of the participants reach the 10,000 steps-per-day target by the end of the 12 week-intervention?
SECONDARY OBJECTIVES:
- The effectiveness (satisfaction, convenience, ease of operation) of all the materials and processes.
II. Examine whether social support from a health coach results in improvements in our measures of adherence and satisfaction.
III. Examine the correlation between self-reported steps per day with improvements in performance on a 1-mile walk test administered at the beginning and the end of the 12-week intervention.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I. COACH-CONDITION: Participants participate in a 12-week physical activity program (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.
ARM II: NO-COACH CONDITION: Participants participate in a 12-week physical activity program (walking program) administered using an IVR system.
- Conditions
- Healthy, Obesity, Postmenopausal
- Being tested
- communication intervention, exercise intervention
- Keywords
- Feasibility study, Interactive voice response system (IVR), health coach, no evidence of disease
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication interventionBehavioural
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.
exercise interventionBehavioural
Participants participate in a 12-week physical activity intervention administered using an IVR system.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: communication intervention; Behavioral: 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. Receives: Behavioral: exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time taken to complete a one mile walk.
Measured: 12 weeks
Secondary outcomes (3)
Changes in anthropometrics, psychometrics and the benefits of a health coach.
Measured: 12 weeks
Weekly effectiveness (satisfaction, convenience, ease of operation) of all the materials and processes as assessed by questionnaires.
Measured: 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.
The steps walked per day and the change in performance on the 1-male walk test are both outcomes.
Measured: 12 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study start1 Apr 2007
- Primary completion1 Nov 2009
- Study completion1 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra Paskett, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940016
- Sponsor's protocol ID
- OSU-05005
- Other IDs
- NCI-2012-00204
- Acronym
- BePHIT
- Status last verified
- Jun 2020
- First submitted
- 13 Jul 2013
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on the Effects of Tailored Communication and Health Coach Support on Physical Activity in Overweight Postmenopausal Women: BePHIT
- ClinicalTrials.gov ID
- NCT01940016
- Acronym / sponsor ID
- BePHIT / OSU-05005
- Conditions
- Healthy, Obesity, Postmenopausal
- Keywords
- Feasibility study, Interactive voice response system (IVR), health coach, no evidence of disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 1 Apr 2007 (actual)
- Primary completion
- 1 Nov 2009 (actual)
- Study completion
- 1 Nov 2009 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To design, develop and test the feasibility of implementing a physical activity intervention using tailored communication and Interactive Voice Response (IVR) technology. We will to address four basic questions to accomplish this aim:
- Among overweight, postmenopausal women, who pass the screening criteria, what is the percentage of women who are willing to participate in a 12-week physical activity intervention that includes two 1-mile walk tests and two visits to the General Clinical Research Center (GCRC)?
- After beginning the study, what proportion of women use the cell phone and land line at least 5 days a week to get a physical activity intervention message?
- How many participants are enrolled and participating in the study at the end of the 12-week intervention period?
- On average, how many steps per day do participants walk? How many of the participants reach the 10,000 steps-per-day target by the end of the 12 week-intervention?
SECONDARY OBJECTIVES:
- The effectiveness (satisfaction, convenience, ease of operation) of all the materials and processes.
II. Examine whether social support from a health coach results in improvements in our measures of adherence and satisfaction.
III. Examine the correlation between self-reported steps per day with improvements in performance on a 1-mile walk test administered at the beginning and the end of the 12-week intervention.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I. COACH-CONDITION: Participants participate in a 12-week physical activity program (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.
ARM II: NO-COACH CONDITION: Participants participate in a 12-week physical activity program (walking program) administered using an IVR system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (health coach) | Experimental | Behavioral: communication intervention, Behavioral: exercise interventionParticipants 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. |
| Arm II (no coach condition) | Active comparator | Behavioral: exercise interventionParticipants 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| communication interventionParticipants 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. | Behavioural | Arm I (health coach) |
| exercise interventionParticipants participate in a 12-week physical activity intervention administered using an IVR system. | Behavioural | Arm I (health coach), Arm II (no coach condition) |
Primary outcome
Change in time taken to complete a one mile walk.
Time frame: 12 weeks
3 secondary outcomes
Changes in anthropometrics, psychometrics and the benefits of a health coach.
Time frame: 12 weeks
Weekly effectiveness (satisfaction, convenience, ease of operation) of all the materials and processes as assessed by questionnaires.
Time frame: 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.
Time frame: 12 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Electra Paskett, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication intervention and exercise intervention in people with Healthy and Obesity, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time taken to complete a one mile walk. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.