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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

Must not have

Uncontrolled hypertension (blood pressure >160/100 mm Hg)

History of unstable angina within the past six months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, and 18 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is not higher than 160/100 mm Hg.

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I have not had unstable chest pain in the last 6 months.

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I have a history of heart failure.

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I have a history of serious infectious diseases like HIV.

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I have a history of chronic hepatitis.

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I have a history of cirrhosis.

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I have a long-term problem absorbing nutrients from food.

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I have a long-term inflammation of my pancreas.

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I have chronic lung or orthopedic issues that affect my physical activity.

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I have lost more than 10 pounds in the last six months.

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I have had weight loss surgery in the past.

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I do not have a major depression, psychiatric disorder, or excessive alcohol use.

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I am not pregnant and do not plan to become pregnant in the next 18 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12, and 18 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Blood pressure

Body composition

Ghrelin

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 14Eligibility criteria met