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

University of California San Diego

Status: Completed

Conditions: Sedentary Lifestyle

Treatments: Other: Tools to prompt standing; Behavioral: Phone counseling call: Healthy living; Behavioral: Phone counseling call: Breaking up sitting time; Behavioral: In-person counseling: Healthy living; Behavioral: In-person counseling: Breaking up sitting time; Device: ActivPAL inclinometer

Study type: Interventional

Funder types: Other

Identifiers

NCT02905929

160682

Details and patient eligibility

About

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.

Full 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.

Enrollment: 254 patients

Sex: Female

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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254 participants in 2 patient groups

Sitting Less group

Experimental group

Description:

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.

Treatment:

Other: Tools to prompt standing

Behavioral: Phone counseling call: Breaking up sitting time

Device: ActivPAL inclinometer

Behavioral: In-person counseling: Breaking up sitting time

Attention Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Phone counseling call: Healthy living

Behavioral: In-person counseling: Healthy living