SCALE: Small Changes and Lasting Effects
SCALE
1 other identifier
interventional
405
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 23, 2017
February 1, 2017
4.9 years
September 8, 2010
February 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 months
Study Arms (2)
Group 1
EXPERIMENTALSubjects 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.
Group 2
EXPERIMENTALSubjects 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.
Interventions
Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.
Subjects will be randomized to the small change eating strategy and a physical activity goal.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Renaissance Health Care Network
New York, New York, 10026, United States
Abyssinian Baptist Church
New York, New York, 10030, United States
Metropolitan Methodist Church
New York, New York, 10035, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, 10451, United States
East Side House Settlement
The Bronx, New York, 10455, United States
Iglesia Congregacion Cristiana del Bronx
The Bronx, New York, 10457, United States
Related Publications (2)
Charlson M, Wells M, Devine CM, Watts J, Ramos R, Hollenberg J, Winston G, Phillips E, Wethington E. Interval life events are an important determinant of heterogeneity in outcomes in a randomised trial: a novel, simple method of assessment. BMJ Open. 2024 Jul 30;14(7):e074623. doi: 10.1136/bmjopen-2023-074623.
PMID: 39079918DERIVEDPhillips 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.
PMID: 28382755DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Charlson, MD
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 10, 2010
Study Start
October 1, 2009
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
February 23, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share
No plan to share IPD has been created