CARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss
NCT ID: NCT02736669
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
223 participants
INTERVENTIONAL
2015-10-31
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fixed Energy (or Calorie) Reduction
Participants randomly assigned to this arm will be instructed to reduce their food intake by a moderate amount and stay at this level of moderate reduction until their weight loss goal is achieved.
Energy Reduction
Variable Energy (or Calorie) Reduction
Participants randomly assigned to this arm will be instructed to alternate between two levels of calorie reduction. One level will be a small amount of calorie reduction, while the other will be a more significant amount of calorie reduction. At the instruction of the research team, participants will periodically alternate back and forth between these two goals until their weight loss goal is achieved.
Energy Reduction
Interventions
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Energy Reduction
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 30-50 kg/m2
Exclusion Criteria
* Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases or orthopedic problems that limit physical activity
* Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, antibiotics for HIV or TB, or chemotherapeutic drugs; prescription weight loss medications (past six months)
* Unwilling or unable to do any of the following: give informed consent; read English at the 5th grade level; accept random assignment; travel to the intervention site
* Likely to relocate out of the area in the next 2 years
* Participation in another randomized research project
* Weight loss \> 10 pounds in past six months
* History of bariatric surgery
* Major depressive or psychiatric disorder, or excessive alcohol intake
* Potential participants living farther than 30 miles driving distance from UAB will be excluded from the study.
* Potential participants (female) that are pregnant or plan to become pregnant in the next 18 months will be excluded from participation in the study. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
21 Years
75 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Gareth R. Dutton PhD
Associate Professor
Principal Investigators
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Gareth R Dutton, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine
Locations
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University of Alabama at Birmingham, Medical Towers Building
Birmingham, Alabama, United States
Countries
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Other Identifiers
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IRB-150303008
Identifier Type: -
Identifier Source: org_study_id