SCALE: Small Changes and Lasting Effects



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:5/5/2014
Start Date:October 2009
End Date:June 2014

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The goal of this study is to translate basic behavioral and social science discoveries into
effective behavioral interventions that reduce obesity and obesity related morbidity in
Black and Latino communities. This intervention will focus on promoting small changes in
eating behavior and increasing physical activity among Black and Latino participants in
Harlem and the South Bronx. The desired result from these activities is individual weight
loss that will be sustained years after participation in the study.

SCALE is a five year study (October 1, 2009 through June 30, 2014) funded by NHLBI. The
study will examine the possibility and acceptance of a mindful eating intervention in
African American and Latino participants. We will test whether positive thinking can protect
participants against the negative impact that stress and depression can have on making
positive behavior changes such as mindful eating and physical activity.

Currently, the SCALE study is in the trial phase. Among overweight or obese Black or Latino
adults who live in Harlem or the South Bronx, the primary goal of this project is to achieve
weight loss of 7% or more over 12 months by making small sustained changes in eating
behavior coupled with sustained increases in physical activity. Participants are enrolled
for 12 months and are randomized to one of two study groups.

Group 1: Will choose one of ten small change eating strategies, a physical activity goal and
will receive the positive affect/self affirmation component.

Group 2: Will choose one of ten small change eating strategies and a physical activity goal

For inquiries regarding potential enrollment in this study, please contact Rosio Ramos at
646-962-5070 or email ror2023@med.cornell.edu

Inclusion Criteria:

Eligibility Criteria:

Black or Latino community-dwelling subjects who are 21 years or older and have a body mass
index of >25 but <50 or considered to be obese or overweight are be eligible for study
participation. All participants must be able to participate in physical activity and Must
be fluent in English or Spanish.

Exclusion Criteria:

Subjects will be excluded if:

1. Unable to provide informed consent in either English or Spanish for any reason,
including cognitive impairment, psychiatric illness, drug or alcohol addiction

2. Pregnant or are planning to become pregnant within the year

3. Participating in another weight loss program or trial

4. On medications for obesity

5. Have a history of bulimia;

6. history of surgery for obesity;

7. Have severe comorbid diseases that can lead to unintentional weight change including
cancer, HIV/AIDS, congestive heart failure.

8. They live in an institutional setting (nursing home, prison or group home).

9. Have severe disease or are terminally ill, including stroke, myocardial infarction,
coronary artery disease requiring angioplasty.

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Bronx, New York 10455
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New York, New York 10030
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