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SCALE: Small Changes and Lasting Effects (SCALE)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1
Group 2
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

  • Lincoln Medical and Mental Health Center
  • East Side House Settlement
  • Iglesia Congregacion Cristiana del Bronx
  • Renaissance Health Care Network
  • Abyssinian Baptist Church
  • Metropolitan Methodist Church

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2010
Last Updated
February 17, 2017
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01198990
Brief Title
SCALE: Small Changes and Lasting Effects
Acronym
SCALE
Official Title
SCALE: Small Changes and Lasting Effects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group 1
Other Intervention Name(s)
eating/physical activity/positive affect/self-affirmation
Intervention Description
Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.
Intervention Type
Behavioral
Intervention Name(s)
Group 2
Other Intervention Name(s)
eating strategy and physical activity goal
Intervention Description
Subjects will be randomized to the small change eating strategy and a physical activity goal.
Primary Outcome Measure Information:
Title
Percent weight loss
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Charlson, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lincoln Medical and Mental Health Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
East Side House Settlement
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Facility Name
Iglesia Congregacion Cristiana del Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Renaissance Health Care Network
City
New York
State/Province
New York
ZIP/Postal Code
10026
Country
United States
Facility Name
Abyssinian Baptist Church
City
New York
State/Province
New York
ZIP/Postal Code
10030
Country
United States
Facility Name
Metropolitan Methodist Church
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD has been created
Citations:
PubMed Identifier
28382755
Citation
Phillips EG, Wells MT, Winston G, Ramos R, Devine CM, Wethington E, Peterson JC, Wansink B, Charlson M. Innovative approaches to weight loss in a high-risk population: The small changes and lasting effects (SCALE) trial. Obesity (Silver Spring). 2017 May;25(5):833-841. doi: 10.1002/oby.21780. Epub 2017 Apr 5.
Results Reference
derived

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SCALE: Small Changes and Lasting Effects

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