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

NCT02736669 | Completed

• 2 other identifiers: IRB-150303008R01DK103863
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

weight loss; body weight; behavioral

Outcome Measures

Primary Outcomes (1)

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

  Participants will be weighed by body scale in kilograms

  Baseline, 6 months, 18 months

Secondary Outcomes (13)

• Resting energy expenditure

  6, 12, and 18 months

• Body composition

  6, 12, and 18 months

• Laboratory analyses

  6, 12, and 18 months

• Blood pressure

  6, 12, and 18 months

• Hormones - ghrelin

  6, 12, and 18 months

Study Arms (2)

Fixed Energy (or Calorie) Reduction

ACTIVE COMPARATOR

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.

Behavioral: Energy Reduction

Variable Energy (or Calorie) Reduction

EXPERIMENTAL

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.

Behavioral: Energy Reduction

Interventions

Energy Reduction BEHAVIORAL

Fixed Energy (or Calorie) Reduction; Variable Energy (or Calorie) Reduction

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama at Birmingham, Medical Towers Building

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Body Weight; Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Gareth R Dutton, PhD

  University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 13, 2016
• Study Start: October 1, 2015
• Primary Completion: April 30, 2021
• Study Completion: December 1, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)