CancerNCT01008787
Motivational Interviewing for Physical Activity
A study testing Training, Questionnaire and Interview in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this behavioral research study is to learn why some African American (AA) women choose not to exercise often and to learn if teaching African American women how to support the exercise habits of a partner will increase their physical activity and help them to stay more active over time. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Training, Questionnaire and Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2009to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American (AA) woman (self-defined by participant) ages 18-65 years
- Currently sedentary, defined as self-reported PA <3 days/week for <20 minutes/day over the past 6 months
- Be ready and physically able to start being physically active, i.e., in preparation stage of change.
- Have a home address where information can be mailed and working telephone.
- Able to read English at a sixth-grade level as assessed by the Rapid Estimate of Adult Literacy in Medicine (REALM)
- Identify a sedentary AA female (i.e., non-intimate family member or friend) with whom they can enroll in the study
- Both partners are required to meet the same eligibility requirements and both partners will be enrolled as participants. Each woman will complete the same consent form.
- Be available to participate in weekend trainings
Who cannot join
- Currently taking medication for blood pressure or heart condition, or other physical limitations that might be aggravated by participation in moderate-intensity PA as measured using the PA Readiness Questionnaire
- Pregnant or thinking about becoming pregnant during the study period
- Thinking about moving to a location outside the greater Houston area during the study period
- Being unable to attend the CAPMI training sessions with their partner
- Participated in Phase I focus group/interviews
- Being a male
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Peer-support Motivational Interviewing Physical Activity Intervention for African American Women
The goal of this behavioral research study is to learn why some African American (AA) women choose not to exercise often and to learn if teaching African American women how to support the exercise habits of a partner will increase their physical activity and help them to stay more active over time.
The primary goal of the proposed intervention is:
Read more
Aim 1: To conduct formative research using semi-structured in-depth interviews and focus groups with sedentary AA women to investigate the role and importance of social support for PA;
Aim 2: To determine the feasibility of recruiting and implementing "Culturally Appropriate Physical Activity Motivational Interviewing" (CAPMI) intervention in sedentary AA women;
Aim 3: To pilot test and evaluate the efficacy of the CAPMI in increasing PA, social support, self-efficacy and reducing barriers to Physical Activity (PA) at post-intervention compared to an attention control group.
Read the detailed description
Focus Group:
If you agree to take part in this study, you will take part in a focus group or individual interview. A focus group is a group of people who are asked questions about certain topics and then discuss these topics with other group members. During the focus group, you will talk about ways that African American women may increase their physical activity. You will also be asked questions about the ways in which you support other women to help them become more physically active. There will be 4 focus groups, each made up of 8-10 women. The focus group session should take 1 1/2 to 2 hours.
The focus group will be audiotaped and transcribed (the spoken words will be typed up). Your individual name will not be used during the focus group and will not be recorded. For example, you will be listed as Participant #1. After the focus group comments are copied down, the focus group tapes will be destroyed. The study staff may also interview you alone. During the individual interview, you will talk about ways that African American women may increase their physical activity. You will also be asked questions about the ways in which you support other women to help them become more physically active. The staff will interview 10 women. The individual interview should take 1 1/2 to 2 hours.
The individual interview will be audiotaped and transcribed. Your individual name will not be used during the interview and will not be recorded. For example, you will be listed as Participant #1. After the interview comments are copied down, the interview tapes will be destroyed.
Length of Study:
You will be on study until you complete the focus group session.
This is an investigational study. Up to 40 women will take part in the focus groups. All will be enrolled at M. D. Anderson.
Intervention:
You will need a partner (a female friend or family member) to take part in this study. Both you and your study partner will need to meet the same eligibility requirements, and both of you will be enrolled as participants. If you choose a partner that is not eligible, you will will need to choose another eligible partner before you can be enrolled in the study.
Screening:
Before you can take part in this study, you will be asked if you are between the ages of 18 and 65 years old, if you are currently not engaging in physical activity for more than 3 days per week and more than 20 minutes each day, and if you are ready to be physically active. You will be asked if you have a home address where information can be mailed, are able to read at a 6th grade level, and are able to participate in a training course that will take place on a weekend.
You will also be asked if you are pregnant or plan to become pregnant during the next 12 weeks. You will also be asked if you plan to move outside of the Houston area in the next 12 weeks. If you are pregnant, plan to become pregnant, and/or plan to move, you will not be able to take part in this study.
Baseline Tests:
If you are found to be eligible to take part in this study, you will complete the following tests and procedures:
- You will be asked how you are feeling and how often you exercise.
- Your height and weight will be measured.
- You will fill out a questionnaire about issues related to your physical activity. It will take 45-60 minutes to complete.
- You will take a walking test, in which you will walk for 6 minutes at a comfortable pace.
- You will receive a pedometer (a monitor that shows how far you walk).
- You may receive an accelerometer and complete a 7-day accelerometer assessment. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group.
Group 1:
If you are in Group 1, you will take part in an 8-hour training course conducted as 2 in-person 4-hour sessions (for example, scheduled on 2 Saturdays in a row) to help you learn how to support the exercise habits of your study partner. At this course, a trainer will give you information and you will take part in activities with your study partner. Sample activities include role playing and watching a video. This will take place on a weekend. The goal of the training course is to help you and your partner engage in physical activity. You will be asked to be physically active for 30 minutes each day.
You will receive a workbook and a DVD about physical activity. You will also be given a form to complete each time you speak with your study partner about physical activity. You will be asked to speak with your partner at least 1 time a week about your physical activities.
Each week during Weeks 1-4, 8, and 12 you will be asked to answer questions on the form given to you at the training course about the conversations you have with your study partner, and to complete recorded conversations via toll-free number. All telephone diaries must be completed and returned to research staff members by week 12 of the study.
At Weeks 4 and 8, you will be called and asked several questions about your mood and your physical activity. The phone call should take about 45 minutes.
At Weeks 5 and 9, you will be mailed a physical activity newsletter.
Group 2:
If you are in Group 2, at Weeks 4 and 8, you will be called and asked several questions about your mood and your physical activity. The phone call should take about 45 minutes.
At Weeks 5 and 9, you will receive a physical activity newsletter.
End-of-Study Visit:
At Week 12 of the study, you will complete the following tests and procedures:
- You will be asked several questions about your mood and your physical activity.
- Your height and weight will be measured.
- You will take a walking test, in which you will walk for 6 minutes at a comfortable pace.
- You may receive an accelerometer and complete a 7-day accelerometer assessment. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.
Length of Study You will be on study for 12 weeks.
This is an investigational study. Up to 80 women will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Cancer
- Being tested
- Training, Questionnaire, Interview, PA Newsletter
- Keywords
- Cancer Prevention, Focus Group, Interview, Physical Activity, African American women, Exercise, Exercise habits, Health behavior
- Medical subject headings
- Neoplasms, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
In-person 8-hour group physical activity training session (either over 1 or 2 days) and receive workbook and pedometer.
QuestionnaireBehavioural
Weekly during Weeks 2-7, complete question form given at training course about conversations with study partner, 5 minutes to complete.
InterviewBehavioural
Weeks 4 and 8, 30 minute phone interview about mood and physical activity.
PA NewsletterBehavioural
At Weeks 5 and 9, receive a physical activity (PA) newsletter.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | No intervention | Qualitative interviews examining social support for PA conducted with African American (AA) women recruited from Wheeler Avenue Baptist Church located in Houston used to design Culturally-Appropriate Peer-based Motivational Interviewing (CAPMI) intervention. |
| Intervention Group 1 | Active comparator | CAPMI Intervention: Training + Weekly Partner Questionnaire + Interview + PA Newsletter Receives: Behavioral: Training; Behavioral: Questionnaire; Behavioral: Interview; Behavioral: PA Newsletter |
| Intervention Group 2 | Active comparator | Interview + PA Newsletter Receives: Behavioral: Interview; Behavioral: PA Newsletter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Minutes of Moderate-intensity Physical Activity per Week
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study start28 Jul 2009
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorna H. McNeill, PhD, MPH, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008787
- Sponsor's protocol ID
- 2008-0257
- Other IDs
- NCI-2012-02123
- Status last verified
- Jul 2026
- First submitted
- 4 Nov 2009
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-support Motivational Interviewing Physical Activity Intervention for African American Women
- ClinicalTrials.gov ID
- NCT01008787
- Acronym / sponsor ID
- 2008-0257
- Conditions
- Cancer
- Keywords
- Cancer Prevention, Focus Group, Interview, Physical Activity, African American women, Exercise, Exercise habits, Health behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 28 Jul 2009 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Nov 2009 (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.
The goal of this behavioral research study is to learn why some African American (AA) women choose not to exercise often and to learn if teaching African American women how to support the exercise habits of a partner will increase their physical activity and help them to stay more active over time.
The primary goal of the proposed intervention is:
Aim 1: To conduct formative research using semi-structured in-depth interviews and focus groups with sedentary AA women to investigate the role and importance of social support for PA;
Aim 2: To determine the feasibility of recruiting and implementing "Culturally Appropriate Physical Activity Motivational Interviewing" (CAPMI) intervention in sedentary AA women;
Aim 3: To pilot test and evaluate the efficacy of the CAPMI in increasing PA, social support, self-efficacy and reducing barriers to Physical Activity (PA) at post-intervention compared to an attention control group.
Detailed description
Focus Group:
If you agree to take part in this study, you will take part in a focus group or individual interview. A focus group is a group of people who are asked questions about certain topics and then discuss these topics with other group members. During the focus group, you will talk about ways that African American women may increase their physical activity. You will also be asked questions about the ways in which you support other women to help them become more physically active. There will be 4 focus groups, each made up of 8-10 women. The focus group session should take 1 1/2 to 2 hours.
The focus group will be audiotaped and transcribed (the spoken words will be typed up). Your individual name will not be used during the focus group and will not be recorded. For example, you will be listed as Participant #1. After the focus group comments are copied down, the focus group tapes will be destroyed. The study staff may also interview you alone. During the individual interview, you will talk about ways that African American women may increase their physical activity. You will also be asked questions about the ways in which you support other women to help them become more physically active. The staff will interview 10 women. The individual interview should take 1 1/2 to 2 hours.
The individual interview will be audiotaped and transcribed. Your individual name will not be used during the interview and will not be recorded. For example, you will be listed as Participant #1. After the interview comments are copied down, the interview tapes will be destroyed.
Length of Study:
You will be on study until you complete the focus group session.
This is an investigational study. Up to 40 women will take part in the focus groups. All will be enrolled at M. D. Anderson.
Intervention:
You will need a partner (a female friend or family member) to take part in this study. Both you and your study partner will need to meet the same eligibility requirements, and both of you will be enrolled as participants. If you choose a partner that is not eligible, you will will need to choose another eligible partner before you can be enrolled in the study.
Screening:
Before you can take part in this study, you will be asked if you are between the ages of 18 and 65 years old, if you are currently not engaging in physical activity for more than 3 days per week and more than 20 minutes each day, and if you are ready to be physically active. You will be asked if you have a home address where information can be mailed, are able to read at a 6th grade level, and are able to participate in a training course that will take place on a weekend.
You will also be asked if you are pregnant or plan to become pregnant during the next 12 weeks. You will also be asked if you plan to move outside of the Houston area in the next 12 weeks. If you are pregnant, plan to become pregnant, and/or plan to move, you will not be able to take part in this study.
Baseline Tests:
If you are found to be eligible to take part in this study, you will complete the following tests and procedures:
- You will be asked how you are feeling and how often you exercise.
- Your height and weight will be measured.
- You will fill out a questionnaire about issues related to your physical activity. It will take 45-60 minutes to complete.
- You will take a walking test, in which you will walk for 6 minutes at a comfortable pace.
- You will receive a pedometer (a monitor that shows how far you walk).
- You may receive an accelerometer and complete a 7-day accelerometer assessment. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group.
Group 1:
If you are in Group 1, you will take part in an 8-hour training course conducted as 2 in-person 4-hour sessions (for example, scheduled on 2 Saturdays in a row) to help you learn how to support the exercise habits of your study partner. At this course, a trainer will give you information and you will take part in activities with your study partner. Sample activities include role playing and watching a video. This will take place on a weekend. The goal of the training course is to help you and your partner engage in physical activity. You will be asked to be physically active for 30 minutes each day.
You will receive a workbook and a DVD about physical activity. You will also be given a form to complete each time you speak with your study partner about physical activity. You will be asked to speak with your partner at least 1 time a week about your physical activities.
Each week during Weeks 1-4, 8, and 12 you will be asked to answer questions on the form given to you at the training course about the conversations you have with your study partner, and to complete recorded conversations via toll-free number. All telephone diaries must be completed and returned to research staff members by week 12 of the study.
At Weeks 4 and 8, you will be called and asked several questions about your mood and your physical activity. The phone call should take about 45 minutes.
At Weeks 5 and 9, you will be mailed a physical activity newsletter.
Group 2:
If you are in Group 2, at Weeks 4 and 8, you will be called and asked several questions about your mood and your physical activity. The phone call should take about 45 minutes.
At Weeks 5 and 9, you will receive a physical activity newsletter.
End-of-Study Visit:
At Week 12 of the study, you will complete the following tests and procedures:
- You will be asked several questions about your mood and your physical activity.
- Your height and weight will be measured.
- You will take a walking test, in which you will walk for 6 minutes at a comfortable pace.
- You may receive an accelerometer and complete a 7-day accelerometer assessment. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.
Length of Study You will be on study for 12 weeks.
This is an investigational study. Up to 80 women will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus Group | No intervention | –Qualitative interviews examining social support for PA conducted with African American (AA) women recruited from Wheeler Avenue Baptist Church located in Houston used to design Culturally-Appropriate Peer-based Motivational Interviewing (CAPMI) intervention. |
| Intervention Group 1 | Active comparator | Behavioral: Training, Behavioral: Questionnaire, Behavioral: Interview, Behavioral: PA NewsletterCAPMI Intervention: Training + Weekly Partner Questionnaire + Interview + PA Newsletter |
| Intervention Group 2 | Active comparator | Behavioral: Interview, Behavioral: PA NewsletterInterview + PA Newsletter |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- African American (AA) woman (self-defined by participant) ages 18-65 years
- Currently sedentary, defined as self-reported PA <3 days/week for <20 minutes/day over the past 6 months
- Be ready and physically able to start being physically active, i.e., in preparation stage of change.
- Have a home address where information can be mailed and working telephone.
- Able to read English at a sixth-grade level as assessed by the Rapid Estimate of Adult Literacy in Medicine (REALM)
Key exclusion criteria (6 listed)
- Currently taking medication for blood pressure or heart condition, or other physical limitations that might be aggravated by participation in moderate-intensity PA as measured using the PA Readiness Questionnaire
- Pregnant or thinking about becoming pregnant during the study period
- Thinking about moving to a location outside the greater Houston area during the study period
- Being unable to attend the CAPMI training sessions with their partner
- Participated in Phase I focus group/interviews
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 |
|---|---|---|
| TrainingIn-person 8-hour group physical activity training session (either over 1 or 2 days) and receive workbook and pedometer. | Behavioural | Intervention Group 1 |
| QuestionnaireWeekly during Weeks 2-7, complete question form given at training course about conversations with study partner, 5 minutes to complete. | Behavioural | Intervention Group 1 |
| InterviewWeeks 4 and 8, 30 minute phone interview about mood and physical activity. | Behavioural | Intervention Group 1, Intervention Group 2 |
| PA NewsletterAt Weeks 5 and 9, receive a physical activity (PA) newsletter. | Behavioural | Intervention Group 1, Intervention Group 2 |
Primary outcome
Self-reported Minutes of Moderate-intensity Physical Activity per Week
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Lorna H. McNeill, PhD, MPH study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training, Questionnaire and Interview in people with Cancer, run by M.D. Anderson 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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Self-reported Minutes of Moderate-intensity Physical Activity per Week (time frame: 7 days). 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 16 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.