Promoting Healthy Lifestyles in Latino Family Dyads



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:4/17/2018
Start Date:April 3, 2018
End Date:April 2021
Contact:Larkin L. Strong, PHD
Email:CR_Study_Registration@mdanderson.org
Phone:713-563-8930

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Tu Salud ¡Si Cuenta! Promoting Healthy Lifestyles in Latino Family Dyads

The goal of this research study is to learn if participating in a program with another family
member in their household can help participants eat healthier and become more physically
active.

Study Groups:

If you are eligible to take part in this study, you and your family member will be randomly
assigned (as in a flip of a coin) to in 1 of 2 groups. You will have an equal chance of being
in any group.

If you are assigned to Group 1, you and your partner will have 6 meetings with a community
health worker who will talk to you about how you can be more physically active and eat
healthier. The community health worker will come to your home 1 time a month for 6 months.

If you are assigned to Group 2, you and your partner will have 6 meetings with a community
health worker who will talk to you about ways to help your home be a safe and healthy place
to live. Topics will include addressing lead hazards, indoor air quality, home safety, and
pesticides. The community health worker will come to your home 1 time a month for 6 months.

Length of Study:

Your participation on this study will be over after you complete the 3rd in-person visit
(described below).

Study Visits:

Study visits will take place at a community center, MD Anderson, or at your home. You will
have 3 visits during the study -- 1 time at the beginning of the study, 1 time about 6 months
after you begin the study, and 1 time about 12 months after you begin the study. The first
study visit may last up to 2 hours. After the first visit, you will be randomly assigned to
your Study Group. The visits at 6 months and 12 months may last up to 90 minutes. The
following procedures will be performed at each study visit:

- You will complete questionnaires about your feelings, moods, your motivation for
physical activity and eating healthy, any social support you may receive from others,
the neighborhood you live in, and other physical activity-related topics. The
questionnaires should take about 45 minutes to complete. For the 2nd and 3rd visits, you
will have the option of completing the questionnaire online before your scheduled visit.
This may reduce the length of your 2nd and 3rd visits.

- You will be asked about your diet.

- Your height, weight, and waist and hip circumference will be measured. To measure your
waist and hip circumference, you may be asked to lift your shirt to expose your stomach
area and lower your pants to expose your mid-hip area. The height, weight, and waist and
hip circumference measurements should take about 10 minutes and will be performed in a
private area.

- You will be given an accelerometer at each visit. An accelerometer is a small device
(about the size of a deck of cards) that measures your physical activity including how
many steps you take. You will wear the accelerometer for 7 days and then return it in an
pre-addressed envelope provided to you.

Additional Information and How Your Data Is Used:

- You may be contacted by phone or mail while you are taking part in this study to remind
you about study visits, study procedures, and counseling calls.

- You will be asked to give the names and contact information of family members and/or
friends for the study staff to contact in the event they cannot reach you first.

- All information collected during your screening questionnaire will need to be shared
with the study chair, the research team, and the community health workers since all
three will be working on various components of the study.

- Your home address may be used to access public information about the area where you
live. This is to help researchers learn about how your neighborhood encourages physical
activity. The results from this study will only be reported as a group and you will not
be identifiable from any products resulting from this study (such as research papers).
Your home address will never be released or published in any form. Your address will be
stored separately from other study data, and only the study chair, the research team,
and the community health workers will be able to see the data after the neighborhood
information has been collected.

- De-identified responses to all study questionnaires along with de-identified
anthropometrics information (e.g., height, weight, and waistline measurements) from
baseline, 6 month, and 12 month study visits will be made available to the study chair
and the research team but not the community health workers.

- You may be contacted in the future to see if you would agree to take part in other
research studies.

- If the accelerometer is lost or stolen, you will not be responsible for the replacement
cost, but you should tell the study staff right away.

After the study has been completed and the results are published, the study staff and
collaborators will have access to the de-identified data files for up to 10 years. These
files will be stored on a password-protected MD Anderson computer server, in case further
questions about the study results and publications need to be addressed. At 10 years, the
data will be completely deleted (destroyed) from the institutional server.

This is an investigational study. Up to 600 participants may be enrolled in this study. All
will take part at MD Anderson.

Inclusion Criteria:

1. Self-reported Hispanic/Latino ethnicity

2. Age 18-65 years

3. Speak English or Spanish

4. Physically able to engage in low-to-moderate PA as assessed by the PA Readiness
Questionnaire (PAR-Q), or with medical clearance

5. Insufficient self-reported moderate-to-vigorous PA (<150 minutes/week) or consumption
of fewer than 5 servings of FV per day

6. Able to enroll with one eligible adult family member in the same household

7. Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, or
Northside, or adjacent neighborhoods

8. Working telephone number

Exclusion Criteria:

1. Pregnancy or considering pregnancy during the study period

2. Participation in the last 90 days in a research study designed to promote physical
activity or healthy eating

3. Plans to move outside the greater Houston area during the study period

4. At increased risk for cardiac problems
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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