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

University of Alabama at Birmingham223 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

223

Conditions

Overweight Obesity

Interventions

Energy ReductionBEHAVIORAL

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Alabama at Birmingham, Medical Towers Building

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Measure change in body weight (kg) from baseline to follow-up assessments

Participants will be weighed by body scale in kilograms

Time frame: Baseline, 6 months, 18 months

Secondary Outcomes

Resting energy expenditure

An indirect calorimeter with the ventilated hood technique will be used for the 30-minute measurement (the first 10 minutes will be excluded from analysis). The respiratory quotient will be calculated as the ratio of carbon dioxide production to oxygen consumption. Resting metabolic rate will be calculated from VO2 and VCO2 measurements using the Weir equation.