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Calorie Reduction for Obesity (CARE Trial)

N/A
Waitlist Available
Led By Gareth R Dutton, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-75
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, and 18 months
Awards & highlights

CARE Trial Summary

This trial will compare two different weight-loss programs to see which is more effective. One program provides fixed calorie reduction recommendations, while the other provides varied calorie reduction recommendations.

Who is the study for?
This trial is for adults aged 21-75 with obesity (BMI of 30-50). It's not suitable for those with certain chronic diseases, uncontrolled high blood pressure, recent heart attacks or strokes, major psychiatric disorders, or a history of significant weight loss or bariatric surgery. Pregnant women and those planning pregnancy are excluded.Check my eligibility
What is being tested?
The CARE Trial aims to compare two diet programs focusing on different methods of calorie reduction to see which one is more effective at helping participants lose weight. Participants will be randomly assigned to follow either a fixed calorie reduction plan or a varied calorie reduction plan.See study design
What are the potential side effects?
While the study itself does not involve medication that could cause side effects, changing dietary habits may lead to temporary discomforts such as hunger pangs, cravings, mood changes, fatigue during adjustment periods and potential nutrient deficiencies if not monitored properly.

CARE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 75 years old.

CARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body weight
Secondary outcome measures
Blood pressure
Body composition
Energy intake
+12 more

CARE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Variable Energy (or Calorie) ReductionExperimental Treatment1 Intervention
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.
Group II: Fixed Energy (or Calorie) ReductionActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,277,806 Total Patients Enrolled
72 Trials studying Obesity
473,907 Patients Enrolled for Obesity
Gareth R Dutton, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants currently being admitted to this trial?

"Based on the information provided by clinicaltrials.gov, this study is not recruiting participants at present. The trial was first posted in October 2015 and last updated in October 2022; however, 1132 other medical trials are actively enrolling patients as we speak."

Answered by AI

What specific demographic is most desirable for this medical experiment?

"This clinical trial is recruiting 223 individuals who are overweight or obese, aged 21 to 75. In particular, applicants must meet the following qualifications: a BMI between 30 and 50 kg/m2."

Answered by AI

Does this research permit individuals who are older than 25 to participate?

"Individuals who are between 21 and 75 years of age can join this clinical trial."

Answered by AI
~23 spots leftby Apr 2025