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Completed

NCT Number: NCT01198990

SCALE: Small Changes and Lasting Effects

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.

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abyssinian Baptist Church, New York, United States

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About this 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 [email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

Group 1

Behavioral

Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.

Other names: eating/physical activity/positive affect/self-affirmation

Group 2

Behavioral

Subjects will be randomized to the small change eating strategy and a physical activity goal.

Other names: eating strategy and physical activity goal

Primary outcomes

  1. Percent weight loss

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Acronym: SCALE

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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