Physical ActivityHIPNCT02394171
Health is Power: An Ecological Theory-based Health Intervention for Women of Color
A study testing Group Cohesion in people with Physical Activity, run by Arizona State University.
Trial summary
Health Is Power (HIP) was a community based health intervention designed to increase physical activity among women of color. It was funded by a grant from the National Cancer Institute of the National Institutes of Health. Read more about this study
- Who is it for?
- Ages 26 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Group Cohesion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Apr 2012
- 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 26 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- African American or Hispanic/ Latina
- Between the ages of 25 and 60 years old
- Able to read, speak, and write in English or Spanish
- Not pregnant or planning to become pregnant within the next 12 months
- Resident of Harris or Travis County, Texas
- Not planning on moving in the next 12 months
Show all 10Show fewer
- Physically inactive or did not do more than 30 min of physical activity per day on 3 or more days per week
- No history of medical illness or currently taking medication (could have medical waiver from physician if did not meet this)
- Willing to be randomized to either a physical activity group or a vegetable and fruit group
- Available between 5:30 and 8:00 PM on meeting dates.
Who cannot join
None listed.
About this study
Health Is Power (HIP) was a community based health intervention designed to increase physical activity among women of color. It was funded by a grant from the National Cancer Institute of the National Institutes of Health. The purposes of the study were (1) to determine whether a 6 month, group cohesion intervention is more effective for increasing physical activity compared to a 6 month, group cohesion comparison targeting improving dietary habits (2) to determine whether residence in a neighborhood supportive for physical activity helped women maintain their physical activity from 6 to , and (3) to determine whether this effect was transculturally replicable.
Read the detailed description
Objective Physical inactivity and poor dietary habits plague Americans as health challenges, with women of color most vulnerable to their detrimental effects. Individually focused interventions have not demonstrated lasting success, possibly due to the lack of focus on sustainable social and physical environment factors. Health Is Power (HIP) was a transcultural, community based, randomized controlled trial that investigated the effectiveness of a group cohesion intervention to increase physical activity in African American and Hispanic or Latina women in Houston and Austin, Texas and then tested whether women living in more supportive areas maintained their physical activity over time. Intervention development was guided by group dynamics principles anchored within an ecologic model. Women participated in three health assessments and a six month face to face intervention that included evidence-based behavioral methods - integrated into strategies to promote group cohesion - framed to account for environmental factors contributing to health disparities. Women participated in team building activities, environmental mapping exercises, and supervised walks or taste tests. Neighborhood contextual and environmental measures were measured to test ecologic factors that may contribute to behavioral maintenance.
- Conditions
- Physical Activity
- Being tested
- Group Cohesion
- Keywords
- Physical Activity, Social Cohesion, Intervention Development, Ethnic Minorities, Nutrition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CohesionBehavioural
See description in arm/group above
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Women completed a physical activity group cohesion intervention which included six content intensive intervention sessions over a 24 week period that focused on specific group dynamics team building strategies to increase physical activity. A small team structure was used for peer problem solving and support throughout the intervention. Teams were given weekly physical activity goals, with slowly increasing weekly minutes milestones to gradually meet recommended amounts of physical activity. Sessions included brief instructions, team-based activities, and discussion with the entire group lead by a trained health educator. The intervention sessions ended with the health educator leading the teams in a brisk 15-minute walk. Receives: Behavioral: Group Cohesion |
| Fruit and Vegetable | Active comparator | Women completed a fruit and vegetable group cohesion intervention which involved six content intensive intervention sessions over a 24 week period that focused on specific group dynamics team building strategies to increase fruit and vegetable consumption. A small team structure was used for peer problem solving and support throughout. Teams were given weekly fruit and vegetable consumption goals at each session, with slowly increasing weekly servings milestones to gradually meet recommended amounts of fruit and vegetable consumption. Sessions included brief instructions, team-based activities, and discussion with the entire group lead by a trained health educator. The intervention sessions ended with the health educator leading the teams in a fruit and vegetable taste test. Receives: Behavioral: Group Cohesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity as measured by accelerometry and the International Physical Activity Questionnaire (IPAQ)
women were measured at baseline and 6 month
Measured: 6 months
Maintenance in Physical Activity as measured by accelerometry and the International Physical Activity Questionnaire (IPAQ)
women were measured at 6 months and 12 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startMay 2005
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Lee, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394171
- Sponsor's protocol ID
- RebeccaLee
- Acronym
- HIP
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2015
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith-Ray RL, Mama S, Reese-Smith JY, Estabrooks PA, Lee RE. Improving participation rates for women of color in health research: the role of group cohesion. Prev Sci. 2012 Feb;13(1):27-35. doi: 10.1007/s11121-011-0241-6.
PubMed 21826476Soltero EG, Hernandez DC, O'Connor DP, Lee RE. Does social support mediate the relationship among neighborhood disadvantage, incivilities, crime and physical activity? Prev Med. 2015 Mar;72:44-9. doi: 10.1016/j.ypmed.2014.12.030. Epub 2015 Jan 3.
PubMed 25562756McAlexander KM, Mama SK, Medina A, O'Connor DP, Lee RE. The concordance of directly and indirectly measured built environment attributes and physical activity adoption. Int J Behav Nutr Phys Act. 2011 Jul 7;8:72. doi: 10.1186/1479-5868-8-72.
PubMed 21736740Lee RE, O'Connor DP, Smith-Ray R, Mama SK, Medina AV, Reese-Smith JY, Banda JA, Layne CS, Brosnan M, Cubbin C, McMillan T, Estabrooks PA. Mediating effects of group cohesion on physical activity and diet in women of color: health is power. Am J Health Promot. 2012 Mar-Apr;26(4):e116-25. doi: 10.4278/ajhp.101215-QUAN-400.
PubMed 22375580McAlexander KM, Mama SK, Medina AV, O'Connor DP, Lee RE. Concordance and correlates of direct and indirect built environment measurement among minority women. Am J Health Promot. 2012 Mar-Apr;26(4):239-44. doi: 10.4278/ajhp.100715-QUAN-241.
PubMed 22375575Ledoux T, Adamus-Leach H, O'Connor DP, Mama S, Lee RE. The association of binge eating and neighbourhood fast-food restaurant availability on diet and weight status. Public Health Nutr. 2015 Feb;18(2):352-60. doi: 10.1017/S1368980013003546. Epub 2014 Jan 24.
PubMed 24476972Lee RE, Mama SK, Medina AV, Reese-Smith JY, Banda JA, Layne CS, Baxter M, O'Connor DP, McNeill L, Estabrooks PA. Multiple measures of physical activity, dietary habits and weight status in African American and Hispanic or Latina women. J Community Health. 2011 Dec;36(6):1011-23. doi: 10.1007/s10900-011-9403-5.
PubMed 21519867Ledoux TA, Mama SK, O'Connor DP, Adamus H, Fraser ML, Lee RE. Home Availability and the Impact of Weekly Stressful Events Are Associated with Fruit and Vegetable Intake among African American and Hispanic/Latina Women. J Obes. 2012;2012:737891. doi: 10.1155/2012/737891. Epub 2012 May 14.
PubMed 22666558Adamus-Leach HJ, Wilson PL, O'Connor DP, Rhode PC, Mama SK, Lee RE. Depression, stress and body fat are associated with binge eating in a community sample of African American and Hispanic women. Eat Weight Disord. 2013 Jun;18(2):221-7. doi: 10.1007/s40519-013-0021-3. Epub 2013 Apr 9.
PubMed 23760851Wilson PL, O'Connor DP, Kaplan CD, Bode S, Mama SK, Lee RE. Relationship of fruit, vegetable, and fat consumption to binge eating symptoms in African American and Hispanic or Latina women. Eat Behav. 2012 Apr;13(2):179-82. doi: 10.1016/j.eatbeh.2012.01.007. Epub 2012 Jan 24.
PubMed 22365808Lee RE, Medina AV, Mama SK, Reese-Smith JY, O'Connor DP, Brosnan M, Cubbin C, McMillan T, Estabrooks PA. Health is Power: an ecological, theory-based health intervention for women of color. Contemp Clin Trials. 2011 Nov;32(6):916-23. doi: 10.1016/j.cct.2011.07.008. Epub 2011 Jul 18.
PubMed 21782975Lopez Y 3rd, O'Connor DP, Ledoux TA, Lee RE. Analysis of body composition methods in a community sample of African American women. Women Health. 2011 Nov 30;51(8):709-23. doi: 10.1080/03630242.2011.623222.
PubMed 22185287Lee RE, Mama SK, Medina AV, Ho A, Adamus HJ. Neighborhood factors influence physical activity among African American and Hispanic or Latina women. Health Place. 2012 Jan;18(1):63-70. doi: 10.1016/j.healthplace.2011.08.013.
PubMed 22243907Mama SK, Quill BE, Fernandez-Esquer ME, Reese-Smith JY, Banda JA, Lee RE. Body image and physical activity among Latina and African American women. Ethn Dis. 2011 Summer;21(3):281-7.
PubMed 21942159Mama SK, McNeill LH, McCurdy SA, Evans AE, Diamond PM, Adamus-Leach HJ, Lee RE. Psychosocial factors and theory in physical activity studies in minorities. Am J Health Behav. 2015 Jan;39(1):68-76. doi: 10.5993/AJHB.39.1.8.
PubMed 25290599
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health is Power: An Ecological Theory-based Health Intervention for Women of Color
- ClinicalTrials.gov ID
- NCT02394171
- Acronym / sponsor ID
- HIP / RebeccaLee
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Social Cohesion, Intervention Development, Ethnic Minorities, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Mar 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.
Health Is Power (HIP) was a community based health intervention designed to increase physical activity among women of color. It was funded by a grant from the National Cancer Institute of the National Institutes of Health. The purposes of the study were (1) to determine whether a 6 month, group cohesion intervention is more effective for increasing physical activity compared to a 6 month, group cohesion comparison targeting improving dietary habits (2) to determine whether residence in a neighborhood supportive for physical activity helped women maintain their physical activity from 6 to , and (3) to determine whether this effect was transculturally replicable.
Detailed description
Objective Physical inactivity and poor dietary habits plague Americans as health challenges, with women of color most vulnerable to their detrimental effects. Individually focused interventions have not demonstrated lasting success, possibly due to the lack of focus on sustainable social and physical environment factors. Health Is Power (HIP) was a transcultural, community based, randomized controlled trial that investigated the effectiveness of a group cohesion intervention to increase physical activity in African American and Hispanic or Latina women in Houston and Austin, Texas and then tested whether women living in more supportive areas maintained their physical activity over time. Intervention development was guided by group dynamics principles anchored within an ecologic model. Women participated in three health assessments and a six month face to face intervention that included evidence-based behavioral methods - integrated into strategies to promote group cohesion - framed to account for environmental factors contributing to health disparities. Women participated in team building activities, environmental mapping exercises, and supervised walks or taste tests. Neighborhood contextual and environmental measures were measured to test ecologic factors that may contribute to behavioral maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Group CohesionWomen completed a physical activity group cohesion intervention which included six content intensive intervention sessions over a 24 week period that focused on specific group dynamics team building strategies to increase physical activity. A small team structure was used for peer problem solving and support throughout the intervention. Teams were given weekly physical activity goals, with slowly increasing weekly minutes milestones to gradually meet recommended amounts of physical activity. Sessions included brief instructions, team-based activities, and discussion with the entire group lead by a trained health educator. The intervention sessions ended with the health educator leading the teams in a brisk 15-minute walk. |
| Fruit and Vegetable | Active comparator | Behavioral: Group CohesionWomen completed a fruit and vegetable group cohesion intervention which involved six content intensive intervention sessions over a 24 week period that focused on specific group dynamics team building strategies to increase fruit and vegetable consumption. A small team structure was used for peer problem solving and support throughout. Teams were given weekly fruit and vegetable consumption goals at each session, with slowly increasing weekly servings milestones to gradually meet recommended amounts of fruit and vegetable consumption. Sessions included brief instructions, team-based activities, and discussion with the entire group lead by a trained health educator. The intervention sessions ended with the health educator leading the teams in a fruit and vegetable taste test. |
Who may qualify
- Ages
- 26 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- African American or Hispanic/ Latina
- Between the ages of 25 and 60 years old
- Able to read, speak, and write in English or Spanish
- Not pregnant or planning to become pregnant within the next 12 months
- Resident of Harris or Travis County, Texas
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 |
|---|---|---|
| Group CohesionSee description in arm/group above | Behavioural | Fruit and Vegetable, Physical Activity |
Primary outcome
Change in Physical Activity as measured by accelerometry and the International Physical Activity Questionnaire (IPAQ)
Time frame: 6 months
women were measured at baseline and 6 month
Maintenance in Physical Activity as measured by accelerometry and the International Physical Activity Questionnaire (IPAQ)
Time frame: 6 months
women were measured at 6 months and 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 20 Mar 2015.
- Background: PubMed 21826476Smith-Ray RL, Mama S, Reese-Smith JY, Estabrooks PA, Lee RE. Improving participation rates for women of color in health research: the role of group cohesion. Prev Sci. 2012 Feb;13(1):27-35. doi: 10.1007/s11121-011-0241-6.
- Background: PubMed 25562756Soltero EG, Hernandez DC, O'Connor DP, Lee RE. Does social support mediate the relationship among neighborhood disadvantage, incivilities, crime and physical activity? Prev Med. 2015 Mar;72:44-9. doi: 10.1016/j.ypmed.2014.12.030. Epub 2015 Jan 3.
- Background: PubMed 21736740McAlexander KM, Mama SK, Medina A, O'Connor DP, Lee RE. The concordance of directly and indirectly measured built environment attributes and physical activity adoption. Int J Behav Nutr Phys Act. 2011 Jul 7;8:72. doi: 10.1186/1479-5868-8-72.
- Background: PubMed 22375580Lee RE, O'Connor DP, Smith-Ray R, Mama SK, Medina AV, Reese-Smith JY, Banda JA, Layne CS, Brosnan M, Cubbin C, McMillan T, Estabrooks PA. Mediating effects of group cohesion on physical activity and diet in women of color: health is power. Am J Health Promot. 2012 Mar-Apr;26(4):e116-25. doi: 10.4278/ajhp.101215-QUAN-400.
- Background: PubMed 22375575McAlexander KM, Mama SK, Medina AV, O'Connor DP, Lee RE. Concordance and correlates of direct and indirect built environment measurement among minority women. Am J Health Promot. 2012 Mar-Apr;26(4):239-44. doi: 10.4278/ajhp.100715-QUAN-241.
- Background: PubMed 24476972Ledoux T, Adamus-Leach H, O'Connor DP, Mama S, Lee RE. The association of binge eating and neighbourhood fast-food restaurant availability on diet and weight status. Public Health Nutr. 2015 Feb;18(2):352-60. doi: 10.1017/S1368980013003546. Epub 2014 Jan 24.
- Background: PubMed 21519867Lee RE, Mama SK, Medina AV, Reese-Smith JY, Banda JA, Layne CS, Baxter M, O'Connor DP, McNeill L, Estabrooks PA. Multiple measures of physical activity, dietary habits and weight status in African American and Hispanic or Latina women. J Community Health. 2011 Dec;36(6):1011-23. doi: 10.1007/s10900-011-9403-5.
- Background: PubMed 22666558Ledoux TA, Mama SK, O'Connor DP, Adamus H, Fraser ML, Lee RE. Home Availability and the Impact of Weekly Stressful Events Are Associated with Fruit and Vegetable Intake among African American and Hispanic/Latina Women. J Obes. 2012;2012:737891. doi: 10.1155/2012/737891. Epub 2012 May 14.
- Background: PubMed 23760851Adamus-Leach HJ, Wilson PL, O'Connor DP, Rhode PC, Mama SK, Lee RE. Depression, stress and body fat are associated with binge eating in a community sample of African American and Hispanic women. Eat Weight Disord. 2013 Jun;18(2):221-7. doi: 10.1007/s40519-013-0021-3. Epub 2013 Apr 9.
- Background: PubMed 22365808Wilson PL, O'Connor DP, Kaplan CD, Bode S, Mama SK, Lee RE. Relationship of fruit, vegetable, and fat consumption to binge eating symptoms in African American and Hispanic or Latina women. Eat Behav. 2012 Apr;13(2):179-82. doi: 10.1016/j.eatbeh.2012.01.007. Epub 2012 Jan 24.
- Background: PubMed 21782975Lee RE, Medina AV, Mama SK, Reese-Smith JY, O'Connor DP, Brosnan M, Cubbin C, McMillan T, Estabrooks PA. Health is Power: an ecological, theory-based health intervention for women of color. Contemp Clin Trials. 2011 Nov;32(6):916-23. doi: 10.1016/j.cct.2011.07.008. Epub 2011 Jul 18.
- Background: PubMed 22185287Lopez Y 3rd, O'Connor DP, Ledoux TA, Lee RE. Analysis of body composition methods in a community sample of African American women. Women Health. 2011 Nov 30;51(8):709-23. doi: 10.1080/03630242.2011.623222.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cohesion in people with Physical Activity, run by Arizona State University.
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 10 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 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Physical Activity as measured by accelerometry and the International Physical Activity Questionnaire (IPAQ) (time frame: 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?
On the ClinicalTrials.gov record for NCT02394171, which also lists 15 linked publications.
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 20 Mar 2015.