Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease

NCT02905929 | Completed

• 1 other identifier: 160682
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Sedentary Lifestyle

Keywords

sedentary behavior; standing; sitting; inclinometer

Outcome Measures

Primary Outcomes (1)

• Sitting, standing and stepping time

  Change in daily time spent sitting, standing and stepping during waking hours as measured objectively by the ActivPAL

  3 months

Secondary Outcomes (14)

• Blood pressure

  3 months

• Depressive symptoms

  3 months

• Improvement in Quality of Life

  3 months

• Anthropometrics

  3 months

• Psychosocial and environmental mediators: benefits and barriers

  3 months

Other Outcomes (13)

• Mitochondrial functioning biomarkers

  3 months

• Epigenetic DNA modification profile

  3 months

• Epigenetic microRNA biomarkers

  3 months

Study Arms (2)

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.

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.

Behavioral: Phone counseling call: Healthy living; Behavioral: In-person counseling: Healthy living

Interventions

ActivPAL inclinometer DEVICE

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.

Sitting Less group

Phone counseling call: Breaking up sitting time BEHAVIORAL

Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.

Sitting Less group

In-person counseling: Breaking up sitting time BEHAVIORAL

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.

Sitting Less group

Phone counseling call: Healthy living BEHAVIORAL

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.

Attention Control

Tools to prompt standing OTHER

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.

Sitting Less group

In-person counseling: Healthy living BEHAVIORAL

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.

Attention Control

Eligibility Criteria

• Age: 55 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Prisoners will not be used for this study.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• South Bay Latino Research Center: collaborator
• San Ysidro Health Center: collaborator
• San Diego State University: collaborator

Study Sites (2)

South Bay Latino Research Center

Chula Vista, California, 91910, United States

Location

UCSD

San Diego, California, 92093, United States

Location

Related Publications (8)

• 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.

  PMID: 8037935 BACKGROUND

• Gardiner PA. Understanding and influencing sedentary behaviour in older adults [dissertation]. Vol Doctorate of Philosophy. Brisbane, Australia: University of Queeensland; 2011.

  BACKGROUND

• 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.

  PMID: 16908215 BACKGROUND

• 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.

  PMID: 16270708 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 3432232 BACKGROUND

• 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.

  PMID: 20181057 BACKGROUND

• 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.

  PMID: 30771560 DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Matthew Allison, MDD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 19, 2016
• Study Start: April 1, 2017
• Primary Completion: April 15, 2020
• Study Completion: March 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)