Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
NCT ID: NCT02905929
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
254 participants
INTERVENTIONAL
2017-04-01
2022-03-30
Brief Summary
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Detailed Description
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1. 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.
2. Investigate the 3 month effect of the intervention to impact the secondary health outcomes of blood pressure, depressive symptoms, and anthropometrics.
3. Explore the psychosocial \& environmental mediators \& moderators of changes in sitting time.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Sitting Less group
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.
ActivPAL inclinometer
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 time
Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.
In-person counseling: Breaking up sitting time
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.
Tools to prompt standing
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.
Attention Control
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.
Phone counseling call: Healthy living
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.
In-person counseling: Healthy living
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.
Interventions
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ActivPAL inclinometer
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 time
Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.
In-person counseling: Breaking up sitting time
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 living
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 standing
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 living
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.
Eligibility Criteria
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Inclusion Criteria
2. Self-identify as Hispanic ethnicity, able to read and write in English or Spanish,
3. Ambulatory, medically stable, able to give informed consent, and safely complete the protocols.
4. Body Mass Index range of 25.0-45.0kg/m2.
5. Sedentary: Average \>8 hours sitting/day, as measured by ActivPAL on 4+ days per week
6. Phone access (to receive counseling)
Prisoners will not be used for this study.
Exclusion Criteria
2. Mental states that would preclude complete understanding of the protocol and compliance.
3. Active cancer or another serious chronic illness that may be associated with weight change
4. Body Mass Index \<25.0 or \>45.0kg/m2.
5. Use of insulin medications.
6. ≤ 8hr average daily sitting time, as measured by ActivPAL.
7. Participating in another clinical trial related to study outcomes (as determined by the PI).
8. Unable to wear devices
55 Years
FEMALE
Yes
Sponsors
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South Bay Latino Research Center
UNKNOWN
San Ysidro Health Center
OTHER
San Diego State University
OTHER
University of California, San Diego
OTHER
Responsible Party
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Matthew Allison
Professor
Principal Investigators
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Matthew Allison, MDD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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South Bay Latino Research Center
Chula Vista, California, United States
UCSD
San Diego, California, United States
Countries
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References
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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.
Gardiner 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.
Norman 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.
Norman 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.
Rosenberg 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.
Takemoto 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.
Other Identifiers
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160682
Identifier Type: -
Identifier Source: org_study_id
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