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SCALE: Small Changes and Lasting Effects

This study is currently recruiting participants.
Verified March 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01198990
First received: September 8, 2010
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
 Behavioral: eating strategy/physical activity/positive affect/self affirmation component
Behavioral: eating strategy and physical activity goal
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: SCALE: Small Changes and Lasting Effects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Percent weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 312
Study Start Date: October 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Behavioral: eating strategy/physical activity/positive affect/self affirmation component
Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.
Experimental: Group 2
Subjects will be randomized to the small change eating strategy and a physical activity goal.
 Behavioral: eating strategy and physical activity goal
Subjects will be randomized to the small change eating strategy and a physical activity goal.

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198990

Locations
United States, New York
Lincoln Medical and Mental Health Center Recruiting
Bronx, New York, United States, 10451
Contact: Jessica Hippolyte     646-962-5070        
East Side House Settlement Recruiting
Bronx, New York, United States, 10455
Contact: Jessica Hippolyte     646-962-5070        
Iglesia Congregacion Cristiana del Bronx Recruiting
Bronx, New York, United States, 10457
Contact: Jessica Hippolyte     646-962-5070        
Metropolitan Methodist Church Recruiting
New York, New York, United States, 10035
Contact: Jessica Hippolyte     646-962-5070        
Abyssinian Baptist Church Recruiting
New York, New York, United States, 10030
Contact: Jessica Hippolyte     646-962-5070        
Renaissance Health Care Network Recruiting
New York, New York, United States, 10026
Contact: Jessica Hippolyte     646-962-5070        
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Mary E. Charlson, MD, Executive Director, Center for Integrative Medicine, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT01198990     History of Changes
Other Study ID Numbers: 0908010566
Study First Received: September 8, 2010
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013