Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatments eating strategy/physical activity/positive affect/self affirmation component, eating strategy and physical activity goal
Phase phase 2
Sponsor Weill Medical College of Cornell University
Start date October 2009
End date June 2014
Trial size 312 participants
Trial identifier NCT01198990, 0908010566

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.
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)
Subjects will be randomized to the small change eating strategy and a physical activity goal.
eating strategy and physical activity goal
Subjects will be randomized to the small change eating strategy and a physical activity goal.

Primary Outcomes

Measure
Percent weight loss
time frame: 12 months

Eligibility Criteria

Male or female participants at least 21 years old.

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. -

Additional Information

Official title SCALE: Small Changes and Lasting Effects
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.