Sedentary LifestyleNCT02905929
Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
A study testing ActivPAL inclinometer, Phone counseling call: Breaking up sitting time and In-person counseling: Breaking up sitting time in people with Sedentary Lifestyle, run by University of California, San Diego at 2 sites in United States.
Trial summary
Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA) Women's Health Program will assess 3-month changes in sitting time, standing time, physical activity and blood pressure in a randomized control trial (RCT). Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- ActivPAL inclinometer, Phone counseling call: Breaking up sitting time and In-person counseling: Breaking up sitting time
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2017to 30 Mar 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal woman, no menstruation for at least 1 year, 55+ years of age.
- Self-identify as Hispanic ethnicity, able to read and write in English or Spanish,
- Ambulatory, medically stable, able to give informed consent, and safely complete the protocols.
- Body Mass Index range of 25.0-45.0kg/m2.
- Sedentary: Average >8 hours sitting/day, as measured by ActivPAL on 4+ days per week
- Phone access (to receive counseling)
Show all 16Show fewer
- Prisoners will not be used for this study.
- Exclusion criteria applicable only to the RCT intervention trial participants include:
- Unable to complete the Short Physical Performance Battery.
- Mental states that would preclude complete understanding of the protocol and compliance.
- Active cancer or another serious chronic illness that may be associated with weight change
- Body Mass Index <25.0 or >45.0kg/m2.
- Use of insulin medications.
- ≤ 8hr average daily sitting time, as measured by ActivPAL.
- Participating in another clinical trial related to study outcomes (as determined by the PI).
- Unable to wear devices
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Bay Latino Research Center
Chula Vista, California, 91910
UCSD
San Diego, California, 92093
About this study
Official title: Randomized Control Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA) Women's Health Program will assess 3-month changes in sitting time, standing time, physical activity and blood pressure in a randomized control trial (RCT). This 2-arm RCT will occur in the community with post menopausal Latina women (N=250) who spend at least 8 hrs/day sitting and have increased risk for cardiovascular disease through high BMI and other cardiometabolic risk factors. Women will be identified through the San Ysidro Health Center and assessed at the South Bay Latino Research Center.
Read the detailed description
Project 2 will address the following aims:
- Investigate the 3 month effect of the intervention to impact the primary behavioral outcomes of sitting, standing and stepping time assessed objectively by a thigh worn inclinometer (ActivPAL) in Latinas at risk for heart disease.
- Investigate the 3 month effect of the intervention to impact the secondary health outcomes of blood pressure, depressive symptoms, and anthropometrics.
- Explore the psychosocial \& environmental mediators \& moderators of changes in sitting time.
- Conditions
- Sedentary Lifestyle
- Being tested
- ActivPAL inclinometer, Phone counseling call: Breaking up sitting time, In-person counseling: Breaking up sitting time, Phone counseling call: Healthy living, Tools to prompt standing
- Keywords
- sedentary behavior, standing, sitting, inclinometer
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivPAL inclinometerDevice
Participants will wear a thigh-worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. The device will monitor their sitting and standing time.
Phone counseling call: Breaking up sitting timeBehavioural
Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.
In-person counseling: Breaking up sitting timeBehavioural
Participants will receive 3 in-person health education sessions. At these sessions participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. Participants will also develop action plans, check-in on goal setting, and use of tools at these sessions.
Phone counseling call: Healthy livingBehavioural
Participants will receive a healthy living educational intervention over the phone, developed and tested by the investigators in previous studies. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.
Tools to prompt standingOther
Investigators will provide standing desks to participants who spend time sitting at a computer. Additional tools to help prompt standing are mechanical and electronic timers set to interrupt long periods of sitting and cues in the environment such as standing during commercial breaks and phone calls.
In-person counseling: Healthy livingBehavioural
Control subjects will receive one in-person counseling session about healthy living. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Sitting Less group | Experimental | The 'reduce sitting' intervention group will receive three in-person health coaching sessions followed by five counseling phone calls. Participants will wear a thigh worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. At each in-person health coaching session participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. In addition to the three initial in-person counseling sessions using the ActivPAL feedback, participants will receive phone calls from the health educator biweekly to help overcome barriers, to work on self-monitoring and planning skills, and to prepare relapse prevention. Tools to help prompt standing, including a standing desk, will also be provided. Receives: Device: ActivPAL inclinometer; Behavioral: Phone counseling call: Breaking up sitting time; Behavioral: In-person counseling: Breaking up sitting time; Other: Tools to prompt standing |
| Attention Control | Active comparator | Participants in the attention control condition will receive a healthy aging educational intervention developed and tested by the investigators in previous studies. This group will receive one in-person coaching session followed by seven phone coaching sessions. Receives: Behavioral: Phone counseling call: Healthy living; Behavioral: In-person counseling: Healthy living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting, standing and stepping time
Change in daily time spent sitting, standing and stepping during waking hours as measured objectively by the ActivPAL
Measured: 3 months
Secondary outcomes (14)
Blood pressure
Change in blood pressure
Measured: 3 months
Depressive symptoms
Change in depressive symptoms, measured with Center for Epidemiologic Studies Depression (CESD) short form. Scores greater than 10 indicate probable depressive symptoms.
Measured: 3 months
Improvement in Quality of Life
Change in quality of life, measured with the EURO-QOL 5-D, a brief 5 item standard scale that has demonstrated validity in populations with diabetes and cardiovascular diseases.
Measured: 3 months
Anthropometrics
Change in body mass index (BMI)
Measured: 3 months
Psychosocial and environmental mediators: benefits and barriers
Investigators will use measures adapted for our pilot that include benefits and barriers to sitting less.
Measured: 3 months
Psychosocial and environmental mediators: self-efficacy
Investigators will use measures adapted for our pilot including self-efficacy to sit less.
Measured: 3 months
Psychosocial and environmental mediators: social support
Investigators will use measures adapted for our pilot including social support surrounding sitting less.
Measured: 3 months
Psychosocial and environmental mediators: home environment support
Investigators will use measures adapted for our pilot including home environment support surrounding sitting less.
Measured: 3 months
Psychosocial and environmental mediators: habit formation
Assessed using the Self-Report Habit Index
Measured: 3 months
Demographic moderators: age
Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Measured: 3 months
Demographic moderators: sex
Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Measured: 3 months
Demographic moderators: education
Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Measured: 3 months
Demographic moderators: marital status
Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Measured: 3 months
Demographic moderators: retirement status
Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start1 Apr 2017
- Primary completion15 Apr 2020
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- South Bay Latino Research Center, San Ysidro Health Center, San Diego State University
- Responsible party
- Principal investigator, Matthew Allison, University of California, San Diego
- Investigators
- Matthew Allison, MDD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905929
- Sponsor's protocol ID
- 160682
- Status last verified
- Oct 2022
- First submitted
- 9 Sep 2016
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with universities or centers in AHA funded research networks.
Publications
Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.
PubMed 8037935Gardiner PA. Understanding and influencing sedentary behaviour in older adults [dissertation]. Vol Doctorate of Philosophy. Brisbane, Australia: University of Queeensland; 2011.
Salmon J, Hume C, Ball K, Booth M, Crawford D. Individual, social and home environment determinants of change in children's television viewing: the Switch-Play intervention. J Sci Med Sport. 2006 Oct;9(5):378-87. doi: 10.1016/j.jsams.2006.06.018. Epub 2006 Aug 14.
PubMed 16908215Norman GJ, Sallis JF, Gaskins R. Comparability and reliability of paper- and computer-based measures of psychosocial constructs for adolescent physical activity and sedentary behaviors. Res Q Exerc Sport. 2005 Sep;76(3):315-23. doi: 10.1080/02701367.2005.10599302.
PubMed 16270708Norman G, Vaughn AA, Roesch S, Sallis JF, Calfas K, Patrick K. Development of decisional balance and self-efficacy measures for adolescent sedentary behaviors. Psychology and Health 2004;19:561-575.
Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
PubMed 3432232Rosenberg DE, Sallis JF, Kerr J, Maher J, Norman GJ, Durant N, Harris SK, Saelens BE. Brief scales to assess physical activity and sedentary equipment in the home. Int J Behav Nutr Phys Act. 2010 Jan 31;7:10. doi: 10.1186/1479-5868-7-10.
PubMed 20181057Takemoto M, Schechtman M, Villa N, Talavera G, Sears DD, Natarajan L, Owen N, Rosenberg DE, Dunstan D, Allison M, Kerr J. Arriba por la Vida Estudio (AVE): Study protocol for a standing intervention targeting postmenopausal Latinas. Contemp Clin Trials. 2019 Apr;79:66-72. doi: 10.1016/j.cct.2019.02.004. Epub 2019 Feb 13.
PubMed 30771560
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
- ClinicalTrials.gov ID
- NCT02905929
- Acronym / sponsor ID
- 160682
- Conditions
- Sedentary Lifestyle
- Keywords
- sedentary behavior, standing, sitting, inclinometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- South Bay Latino Research Center, San Ysidro Health Center, San Diego State University
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 19 Sep 2016 (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.
Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA) Women's Health Program will assess 3-month changes in sitting time, standing time, physical activity and blood pressure in a randomized control trial (RCT). This 2-arm RCT will occur in the community with post menopausal Latina women (N=250) who spend at least 8 hrs/day sitting and have increased risk for cardiovascular disease through high BMI and other cardiometabolic risk factors. Women will be identified through the San Ysidro Health Center and assessed at the South Bay Latino Research Center.
Detailed description
Project 2 will address the following aims:
- Investigate the 3 month effect of the intervention to impact the primary behavioral outcomes of sitting, standing and stepping time assessed objectively by a thigh worn inclinometer (ActivPAL) in Latinas at risk for heart disease.
- Investigate the 3 month effect of the intervention to impact the secondary health outcomes of blood pressure, depressive symptoms, and anthropometrics.
- Explore the psychosocial \& environmental mediators \& moderators of changes in sitting time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitting Less group | Experimental | Device: ActivPAL inclinometer, Behavioral: Phone counseling call: Breaking up sitting time, Behavioral: In-person counseling: Breaking up sitting time, Other: Tools to prompt standingThe 'reduce sitting' intervention group will receive three in-person health coaching sessions followed by five counseling phone calls. Participants will wear a thigh worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. At each in-person health coaching session participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. In addition to the three initial in-person counseling sessions using the ActivPAL feedback, participants will receive phone calls from the health educator biweekly to help overcome barriers, to work on self-monitoring and planning skills, and to prepare relapse prevention. Tools to help prompt standing, including a standing desk, will also be provided. |
| Attention Control | Active comparator | Behavioral: Phone counseling call: Healthy living, Behavioral: In-person counseling: Healthy livingParticipants in the attention control condition will receive a healthy aging educational intervention developed and tested by the investigators in previous studies. This group will receive one in-person coaching session followed by seven phone coaching sessions. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Postmenopausal woman, no menstruation for at least 1 year, 55+ years of age.
- Self-identify as Hispanic ethnicity, able to read and write in English or Spanish,
- Ambulatory, medically stable, able to give informed consent, and safely complete the protocols.
- Body Mass Index range of 25.0-45.0kg/m2.
- Sedentary: Average >8 hours sitting/day, as measured by ActivPAL on 4+ days per week
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 |
|---|---|---|
| ActivPAL inclinometerParticipants will wear a thigh-worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. The device will monitor their sitting and standing time. | Device | Sitting Less group |
| Phone counseling call: Breaking up sitting timeParticipants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools. | Behavioural | Sitting Less group |
| In-person counseling: Breaking up sitting timeParticipants will receive 3 in-person health education sessions. At these sessions participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. Participants will also develop action plans, check-in on goal setting, and use of tools at these sessions. | Behavioural | Sitting Less group |
| Phone counseling call: Healthy livingParticipants will receive a healthy living educational intervention over the phone, developed and tested by the investigators in previous studies. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes. | Behavioural | Attention Control |
| Tools to prompt standingInvestigators will provide standing desks to participants who spend time sitting at a computer. Additional tools to help prompt standing are mechanical and electronic timers set to interrupt long periods of sitting and cues in the environment such as standing during commercial breaks and phone calls. | Other | Sitting Less group |
| In-person counseling: Healthy livingControl subjects will receive one in-person counseling session about healthy living. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes. | Behavioural | Attention Control |
Primary outcome
Sitting, standing and stepping time
Time frame: 3 months
Change in daily time spent sitting, standing and stepping during waking hours as measured objectively by the ActivPAL
14 secondary outcomes
Blood pressure
Time frame: 3 months
Depressive symptoms
Time frame: 3 months
Improvement in Quality of Life
Time frame: 3 months
Anthropometrics
Time frame: 3 months
Psychosocial and environmental mediators: benefits and barriers
Time frame: 3 months
Psychosocial and environmental mediators: self-efficacy
Time frame: 3 months
Psychosocial and environmental mediators: social support
Time frame: 3 months
Psychosocial and environmental mediators: home environment support
Time frame: 3 months
Psychosocial and environmental mediators: habit formation
Time frame: 3 months
Demographic moderators: age
Time frame: 3 months
Demographic moderators: sex
Time frame: 3 months
Demographic moderators: education
Time frame: 3 months
Demographic moderators: marital status
Time frame: 3 months
Demographic moderators: retirement status
Time frame: 3 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 4 Oct 2022.
- Background: PubMed 8037935Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.
- BackgroundGardiner PA. Understanding and influencing sedentary behaviour in older adults [dissertation]. Vol Doctorate of Philosophy. Brisbane, Australia: University of Queeensland; 2011.
- Background: PubMed 16908215Salmon J, Hume C, Ball K, Booth M, Crawford D. Individual, social and home environment determinants of change in children's television viewing: the Switch-Play intervention. J Sci Med Sport. 2006 Oct;9(5):378-87. doi: 10.1016/j.jsams.2006.06.018. Epub 2006 Aug 14.
- Background: PubMed 16270708Norman GJ, Sallis JF, Gaskins R. Comparability and reliability of paper- and computer-based measures of psychosocial constructs for adolescent physical activity and sedentary behaviors. Res Q Exerc Sport. 2005 Sep;76(3):315-23. doi: 10.1080/02701367.2005.10599302.
- BackgroundNorman G, Vaughn AA, Roesch S, Sallis JF, Calfas K, Patrick K. Development of decisional balance and self-efficacy measures for adolescent sedentary behaviors. Psychology and Health 2004;19:561-575.
- Background: PubMed 3432232Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
- Background: PubMed 20181057Rosenberg DE, Sallis JF, Kerr J, Maher J, Norman GJ, Durant N, Harris SK, Saelens BE. Brief scales to assess physical activity and sedentary equipment in the home. Int J Behav Nutr Phys Act. 2010 Jan 31;7:10. doi: 10.1186/1479-5868-7-10.
- Derived from this study: PubMed 30771560Takemoto M, Schechtman M, Villa N, Talavera G, Sears DD, Natarajan L, Owen N, Rosenberg DE, Dunstan D, Allison M, Kerr J. Arriba por la Vida Estudio (AVE): Study protocol for a standing intervention targeting postmenopausal Latinas. Contemp Clin Trials. 2019 Apr;79:66-72. doi: 10.1016/j.cct.2019.02.004. Epub 2019 Feb 13.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with universities or centers in AHA funded research networks.
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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.
Matthew Allison, MDD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActivPAL inclinometer, Phone counseling call: Breaking up sitting time and In-person counseling: Breaking up sitting time in people with Sedentary Lifestyle, run by University of California, San Diego at 2 sites 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 16 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sitting, standing and stepping time (time frame: 3 months). 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 NCT02905929, which also lists 8 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 4 Oct 2022.