CARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss

The University of Alabama at Birmingham

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Energy Reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02736669

IRB-150303008

R01DK103863

Details and patient eligibility

About

This research study will compare two weight loss programs that provide different recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in an effort to determine if fixed calorie reduction or varied calorie reduction is more effective for weight loss.

Enrollment: 223 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 21-75
• Body mass index (BMI) 30-50 kg/m2

Exclusion criteria

• Uncontrolled hypertension (blood pressure >160/100 mm Hg)
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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223 participants in 2 patient groups

Fixed Energy (or Calorie) Reduction

Active Comparator group

Description:

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.

Treatment:

Behavioral: Energy Reduction

Variable Energy (or Calorie) Reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Energy Reduction