SCALE: Small Changes and Lasting Effects

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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SCALE: Small Changes and Lasting Effects

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Group 1
* Behavioral: Group 2


Participation Criteria
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Eligibility Criteria
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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: Unable to provide informed consent in either English or Spanish for any reason, including cognitive impairment, psychiatric illness, drug or alcohol addiction Pregnant or are planning to become pregnant within the year Participating in another weight loss program or trial On medications for obesity Have a history of bulimia; history of surgery for obesity; Have severe comorbid diseases that can lead to unintentional weight change including cancer, HIV/AIDS, congestive heart failure. They live in an institutional setting (nursing home, prison or group home). Have severe disease or are terminally ill, including stroke, myocardial infarction, coronary artery disease requiring angioplasty. -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Subjects in will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component. eating/physical activity/positive affect/self-affirmation group. | Behavioral: Group 1<br>* Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.<br>* Other names: eating/physical activity/positive affect/self-affirmation;|
| Experimental: Group 2<br>Subjects will be randomized to the small change eating strategy and a physical activity goal. eating/physical activity group. No intervention, just the eating strategy and physical activity components. | Behavioral: Group 2<br>* Subjects will be randomized to the small change eating strategy and a physical activity goal.<br>* Other names: eating strategy and physical activity goal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight loss | 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. | 12 months |