SCALE: Small Changes and Lasting Effects (SCALE)

February 17, 2017 updated by: Mary E. Charlson, MD, Weill Medical College of Cornell University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10451
        • Lincoln Medical and Mental Health Center
      • Bronx, New York, United States, 10455
        • East Side House Settlement
      • Bronx, New York, United States, 10457
        • Iglesia Congregacion Cristiana del Bronx
      • New York, New York, United States, 10026
        • Renaissance Health Care Network
      • New York, New York, United States, 10030
        • Abyssinian Baptist Church
      • New York, New York, United States, 10035
        • Metropolitan Methodist Church

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1

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
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
Experimental: Group 2

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0908010566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD has been created

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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