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Completed

NCT Number: NCT02736669

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

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.

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Key information

Conditions

Overweight Behavior Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Medical Towers Building

Birmingham, Alabama, 35205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Energy Reduction

Behavioral

Primary outcomes

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

    Time frame: Baseline, 6 months, 18 months

    Participants will be weighed by body scale in kilograms

Secondary outcomes

  1. Resting energy expenditure

    Time frame: 6, 12, and 18 months

    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.

  2. Body composition

    Time frame: 6, 12, and 18 months

    Assessed by full body DXA scan to evaluate percentage of body fat.

  3. Laboratory analyses

    Time frame: 6, 12, and 18 months

    Glucose, lipids, and insulin will be analyzed using blood samples.

  4. Blood pressure

    Time frame: 6, 12, and 18 months

    After a 5 minute seated rest, three measurements using an automated blood pressure device will be taken to obtain the average systolic and diastolic blood pressures.

  5. Hormones - ghrelin

    Time frame: 6, 12, and 18 months

    Total ghrelin will be assessed using blood samples.

  6. Hormones - leptin

    Time frame: 6, 12, and 18 months

    Total leptin will be assessed using blood samples.

  7. Satiety/hunger

    Time frame: 6, 12, and 18 months

    Visual analogue scales (VAS) will be used to measure subjective ratings of appetite. Participants will be asked to provide a rating in response to several questions (e.g., "How hungry did you feel this week? How much did you think about food this week?") using a 100-mm line ranging from "not at all" to "extremely".

  8. Physical activity - objective

    Time frame: 6, 12, and 18 months

    Will be assessed via accelerometers worn by participants for seven days. Participants will be instructed to position the accelerometer at the right hip and to wear the device throughout the day except when sleeping, bathing, or participating in swimming or other water activities. These data will be used to estimate total minutes of moderate- to vigorous-intensity PA.

  9. Physical activity - self-report

    Time frame: 6, 12, and 18 months

    Self-reported PA will also be assessed with the Paffenbarger Physical Activity Questionnaire (PPAQ). Both methods of PA measurement are included, as accelerometers provide objective information about total levels of activity, while the PPAQ provides additional details about the type and schedule of activities.

  10. Treatment adherence

    Time frame: 6, 12, and 18 months

    Treatment adherence will be assessed by the number of treatment sessions attended as well as the number of self-monitoring forms completed, which have both been used as indicators of adherence in our previous work

  11. Treatment novelty

    Time frame: 6, 12, and 18 months

    This construct will be evaluated with a 6-item measure of treatment reinforcement that assesses the extent to which participants enjoy and become less habituated to the behavioral strategies required for weight loss.

  12. Treatment burden

    Time frame: 6, 12, and 18 months

    Behavioral burden of treatment will be assessed with a modified version of the Treatment Burden Questionnaire (TBQ), which includes 15 items measuring the burden of treatment, including behaviors of self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships.

  13. Treatment satisfaction

    Time frame: 6, 12, and 18 months

    Participants will complete a modified version of the Treatment Satisfaction Questionnaire for Medication (TSQM) to assess attitudes and satisfaction regarding the weight loss intervention, energy prescriptions provided, and weight loss achieved. A composite score of treatment satisfaction will be calculated based on participants' responses.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Fixed Versus Variable Energy Reduction During Behavioral Obesity Treatment

Acronym: CARE

Important dates

Study start
2015
Primary completion
2021
Study completion
2025
First posted
Apr 13, 2016
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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