Clinical trial NCT02905929: Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
Official title: Randomized Control Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: sedentary behavior
standing
sitting
inclinometer
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: South Bay Latino Research Center
name: San Ysidro Health Center
name: San Diego State University
First posted: 2016-09-19
Enrollment: 254
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Project 2 will address the following aims:

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.

Eligibility criteria: Inclusion criteria for RCT (n=250):

1. Postmenopausal woman, no menstruation for at least 1 year, 55+ years of age.
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 applicable only to the RCT intervention trial participants include:

1. Unable to complete the Short Physical Performance Battery.
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

Primary outcomes:
measure: Sitting, standing and stepping time
timeFrame: 3 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 3 months
measure: Depressive symptoms
timeFrame: 3 months
measure: Improvement in Quality of Life
timeFrame: 3 months
measure: Anthropometrics
timeFrame: 3 months
measure: Psychosocial and environmental mediators: benefits and barriers
timeFrame: 3 months
measure: Psychosocial and environmental mediators: self-efficacy
timeFrame: 3 months
measure: Psychosocial and environmental mediators: social support
timeFrame: 3 months
measure: Psychosocial and environmental mediators: home environment support
timeFrame: 3 months
measure: Psychosocial and environmental mediators: habit formation
timeFrame: 3 months
measure: Demographic moderators: age
timeFrame: 3 months
measure: Demographic moderators: sex
timeFrame: 3 months
measure: Demographic moderators: education
timeFrame: 3 months
measure: Demographic moderators: marital status
timeFrame: 3 months
measure: Demographic moderators: retirement status
timeFrame: 3 months
Other outcomes:
measure: Mitochondrial functioning biomarkers
timeFrame: 3 months
measure: Epigenetic DNA modification profile
timeFrame: 3 months
measure: Epigenetic microRNA biomarkers
timeFrame: 3 months
measure: Vascular environment/endothelial functioning biomarker 1
timeFrame: 3 months
measure: Vascular environment/endothelial functioning biomarker 2
timeFrame: 3 months
measure: Vascular environment/endothelial functioning biomarker 3
timeFrame: 3 months
measure: Vascular environment/endothelial functioning biomarker 4
timeFrame: 3 months
measure: Vascular environment/endothelial functioning biomarker 5
timeFrame: 3 months
measure: Vascular environment/endothelial functioning biomarker 6
timeFrame: 3 months
measure: Glucoregulatory and lipid metabolism biomarker 1
timeFrame: 3 months
measure: Glucoregulatory and lipid metabolism biomarker 2
timeFrame: 3 months
measure: Glucoregulatory and lipid metabolism biomarker 3
timeFrame: 3 months
measure: Glucoregulatory and lipid metabolism biomarker 4
timeFrame: 3 months
Locations:
city: Chula Vista
country: United States
facility: South Bay Latino Research Center
state: California
city: San Diego
country: United States
facility: UCSD
state: California
Study officials:
affiliation: University of California, San Diego
name: Matthew Allison, MDD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.