Clinical trial NCT02736669: CARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss
Official title: Fixed Versus Variable Energy Reduction During Behavioral Obesity Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight
Obesity
Keywords: weight loss
body weight
behavioral
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-04-13
Enrollment: 223
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measure change in body weight (kg) from baseline to follow-up assessments
timeFrame: Baseline, 6 months, 18 months
Secondary outcomes:
measure: Resting energy expenditure
timeFrame: 6, 12, and 18 months
measure: Body composition
timeFrame: 6, 12, and 18 months
measure: Laboratory analyses
timeFrame: 6, 12, and 18 months
measure: Blood pressure
timeFrame: 6, 12, and 18 months
measure: Hormones - ghrelin
timeFrame: 6, 12, and 18 months
measure: Hormones - leptin
timeFrame: 6, 12, and 18 months
measure: Satiety/hunger
timeFrame: 6, 12, and 18 months
measure: Physical activity - objective
timeFrame: 6, 12, and 18 months
measure: Physical activity - self-report
timeFrame: 6, 12, and 18 months
measure: Treatment adherence
timeFrame: 6, 12, and 18 months
measure: Treatment novelty
timeFrame: 6, 12, and 18 months
measure: Treatment burden
timeFrame: 6, 12, and 18 months
measure: Treatment satisfaction
timeFrame: 6, 12, and 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Medical Towers Building
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine
name: Gareth R Dutton, PhD
role: PRINCIPAL_INVESTIGATOR
References: