SCALE: Small Changes and Lasting Effects

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT01198990

Collaborator

(none)

405

Enrollment

Locations

Arms

Duration (Months)

67.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Overweight Obesity	Behavioral: Group 1 Behavioral: Group 2	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

405 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

SCALE: Small Changes and Lasting Effects

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percent weight loss [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lincoln Medical and Mental Health Center	Bronx	New York	United States	10451
2	East Side House Settlement	Bronx	New York	United States	10455
3	Iglesia Congregacion Cristiana del Bronx	Bronx	New York	United States	10457
4	Renaissance Health Care Network	New York	New York	United States	10026
5	Abyssinian Baptist Church	New York	New York	United States	10030
6	Metropolitan Methodist Church	New York	New York	United States	10035

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator: Mary Charlson, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mary E. Charlson, MD, Principal Investigator, Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT01198990

Other Study ID Numbers:

0908010566

First Posted:

Sep 10, 2010

Last Update Posted:

Feb 23, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Feb 23, 2017