Physical ActivityHIPPNCT02574689
Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South
A study testing HIPP in people with Physical Activity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This pilot study represents an initial foray into delivering home-based individually-tailored physical activity interventions for cancer risk reduction among African American women in the Deep South. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- HIPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2019
- 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 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American
- Post-menopausal (defined as not having menstrual periods for at least 12 months)
- Not taking hormone replacement therapy
- Healthy (BMI 18.5-40; No history of heart disease, myocardial infarction, angina, stroke, or orthopedic conditions which limit mobility, or any serious medical condition that would make physical activity unsafe; no psychiatric hospitalization in past 3 years).
- Not taking medication that may impair physical activity tolerance or performance (e.g., beta blockers).
- Not planning to move from the area for the next 12 months
- Willing to be randomized to either study arm and adhere to study protocol
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
This pilot study represents an initial foray into delivering home-based individually-tailored physical activity interventions for cancer risk reduction among African American women in the Deep South.
Read the detailed description
80 women will receive the HIPP Intervention or Wellness Contact Control. While main outcomes are focused on feasibility and acceptability, physical activity, fitness, and body weight and composition data will be collected at baseline, 6 months, and 12 months, along with blood draws.
HIPP Intervention: The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and, emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports. Computer expert system feedback reports will be based on participants' monthly update survey data and include information on:
- current stage of motivational readiness for physical activity;
- increasing self- efficacy (i.e., confidence) for physical activity participation;
- weighing the pros and cons of engaging in physical activity (decisional balance);
- social support from family and friends for physical activity participation;
- outcome expectations (beliefs regarding the consequences of physical activity participation);
- perceived enjoyment of physical activity;
- how the participant compares to her prior responses (progress feedback);
- how the participant compares to individuals who are physically active and with national guidelines (normative feedback);
- self monitoring of physical activity behavior (using pedometers and activity logs to track the total steps and minutes of moderate intensity physical activity per day).
The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity. Intervention participants will also receive tip sheets addressing physical activity barriers specific to African American women in the Deep South (as identified during our focus groups and comprehensive literature review).
Wellness Contact Control Condition: Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society (ACS) website (www.cancer.org) will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
- Conditions
- Physical Activity
- Being tested
- HIPP, Wellness contact control
- Keywords
- Physical Activity, Cancer Prevention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPPBehavioural
The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and includes motivation-matched physical activity manuals and individually-tailored computer expert system feedback reports. Tailored reports are based on participants' monthly update survey data and cover: 1) current stage of change; 2) self-efficacy; 3) decisional balance; 4) social support; 5) outcome expectations; 6) enjoyment; 7) progress feedback; 8) normative feedback; 9) self regulation. The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity.
Wellness contact controlBehavioural
Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society website (www.cancer.org) are mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
| Study group | Role | What they receive |
|---|---|---|
| HIPP Intervention | Experimental | The physical activity intervention emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports. Receives: Behavioral: HIPP |
| Wellness Contact Control | Active comparator | Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the ACS website (www.cancer.org) will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials. Receives: Behavioral: Wellness contact control |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
minutes/week of moderate intensity or greater physical activity
Measured: baseline and 6 months
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
minutes/week of moderate intensity or greater physical activity
Measured: baseline and 12 months
Secondary outcomes (12)
6 minute walk test
meters walked in 6 minutes
Measured: baseline, 6 months, 12 months
body mass index
kg/m^2
Measured: baseline, 6 months, 12 months
waist circumference
cm
Measured: baseline, 6 months, 12 months
body impedance analyses
% body fat
Measured: baseline, 6 months, 12 months
Social Support for exercise scale
range=0-65 for both friends and family subscales, with higher scores indicating more social support
Measured: baseline, 6 months, 12 months
Outcome expectations scale
range= 1-5, with higher scores representing more outcome expectations
Measured: baseline, 6 months, 12 months
Physical Activity Enjoyment scale
range=18-126, with higher scores indicating more enjoyment
Measured: baseline, 6 months, 12 months
accelerometers
minutes/week of moderate intensity or greater physical activity
Measured: baseline, 6 months, 12 months
Stages of Readiness Measure
categorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)
Measured: baseline, 6 months, 12 months
Self -Efficacy for physical activity scale
range= 1-5, with higher scores representing more self-efficacy
Measured: baseline, 6 months, 12 months
processes of change measure
range= 1-5, with higher scores representing greater use of cognitive and/or behavioral processes of change
Measured: baseline, 6 months, 12 months
Decisional Balance scale
scores >0 indicate more advantages than disadvantages to physical activity
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Dorothy Pekmezi, PhD, University of Alabama at Birmingham
- Investigators
- Dori Pekmezi, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574689
- Sponsor's protocol ID
- X130405004
- Acronym
- HIPP
- Status last verified
- Apr 2020
- First submitted
- 15 Sep 2015
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South
- ClinicalTrials.gov ID
- NCT02574689
- Acronym / sponsor ID
- HIPP / X130405004
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Sep 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 14 Oct 2015 (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 pilot study represents an initial foray into delivering home-based individually-tailored physical activity interventions for cancer risk reduction among African American women in the Deep South.
Detailed description
80 women will receive the HIPP Intervention or Wellness Contact Control. While main outcomes are focused on feasibility and acceptability, physical activity, fitness, and body weight and composition data will be collected at baseline, 6 months, and 12 months, along with blood draws.
HIPP Intervention: The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and, emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports. Computer expert system feedback reports will be based on participants' monthly update survey data and include information on:
- current stage of motivational readiness for physical activity;
- increasing self- efficacy (i.e., confidence) for physical activity participation;
- weighing the pros and cons of engaging in physical activity (decisional balance);
- social support from family and friends for physical activity participation;
- outcome expectations (beliefs regarding the consequences of physical activity participation);
- perceived enjoyment of physical activity;
- how the participant compares to her prior responses (progress feedback);
- how the participant compares to individuals who are physically active and with national guidelines (normative feedback);
- self monitoring of physical activity behavior (using pedometers and activity logs to track the total steps and minutes of moderate intensity physical activity per day).
The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity. Intervention participants will also receive tip sheets addressing physical activity barriers specific to African American women in the Deep South (as identified during our focus groups and comprehensive literature review).
Wellness Contact Control Condition: Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society (ACS) website (www.cancer.org) will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIPP Intervention | Experimental | Behavioral: HIPPThe physical activity intervention emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports. |
| Wellness Contact Control | Active comparator | Behavioral: Wellness contact controlCancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the ACS website (www.cancer.org) will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- African American
- Post-menopausal (defined as not having menstrual periods for at least 12 months)
- Not taking hormone replacement therapy
- Healthy (BMI 18.5-40; No history of heart disease, myocardial infarction, angina, stroke, or orthopedic conditions which limit mobility, or any serious medical condition that would make physical activity unsafe; no psychiatric hospitalization in past 3 years).
- Not taking medication that may impair physical activity tolerance or performance (e.g., beta blockers).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HIPPThe physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and includes motivation-matched physical activity manuals and individually-tailored computer expert system feedback reports. Tailored reports are based on participants' monthly update survey data and cover: 1) current stage of change; 2) self-efficacy; 3) decisional balance; 4) social support; 5) outcome expectations; 6) enjoyment; 7) progress feedback; 8) normative feedback; 9) self regulation. The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity. | Behavioural | HIPP Intervention |
| Wellness contact controlCancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society website (www.cancer.org) are mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials. | Behavioural | Wellness Contact Control |
Primary outcome
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
Time frame: baseline and 6 months
minutes/week of moderate intensity or greater physical activity
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
Time frame: baseline and 12 months
minutes/week of moderate intensity or greater physical activity
12 secondary outcomes
6 minute walk test
Time frame: baseline, 6 months, 12 months
body mass index
Time frame: baseline, 6 months, 12 months
waist circumference
Time frame: baseline, 6 months, 12 months
body impedance analyses
Time frame: baseline, 6 months, 12 months
Social Support for exercise scale
Time frame: baseline, 6 months, 12 months
Outcome expectations scale
Time frame: baseline, 6 months, 12 months
Physical Activity Enjoyment scale
Time frame: baseline, 6 months, 12 months
accelerometers
Time frame: baseline, 6 months, 12 months
Stages of Readiness Measure
Time frame: baseline, 6 months, 12 months
Self -Efficacy for physical activity scale
Time frame: baseline, 6 months, 12 months
processes of change measure
Time frame: baseline, 6 months, 12 months
Decisional Balance scale
Time frame: baseline, 6 months, 12 months
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 21 Apr 2020.
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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.
Dori Pekmezi, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIPP in people with Physical Activity, run by University of Alabama at Birmingham 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 7 inclusion and 0 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 21 Apr 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?
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview) (time frame: baseline and 6 months). The study lists 2 primary outcomes in all. 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 21 Apr 2020.