Clinical trial NCT01198990: SCALE: Small Changes and Lasting Effects
Official title: SCALE: Small Changes and Lasting Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 405
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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:

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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Primary outcomes:
measure: Percent weight loss
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Lincoln Medical and Mental Health Center
state: New York
city: Bronx
country: United States
facility: East Side House Settlement
state: New York
city: Bronx
country: United States
facility: Iglesia Congregacion Cristiana del Bronx
state: New York
city: New York
country: United States
facility: Renaissance Health Care Network
state: New York
city: New York
country: United States
facility: Abyssinian Baptist Church
state: New York
city: New York
country: United States
facility: Metropolitan Methodist Church
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mary Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.