223 Participants Needed

Calorie Reduction for Obesity

(CARE Trial)

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, antibiotics for HIV or TB, chemotherapeutic drugs, and prescription weight loss medications.

What data supports the effectiveness of the treatment Energy Reduction for obesity?

Research shows that reducing calorie intake can lead to weight loss of 5-10 kg over six months, which is considered clinically meaningful. This approach is often the first step recommended in obesity treatment guidelines.12345

Is calorie reduction generally safe for humans?

Calorie reduction, when combined with regular exercise and behavioral changes, is generally safe and can be beneficial for health. However, very low-calorie diets alone are not effective long-term, and some weight loss supplements lack rigorous safety testing.678910

How does the treatment 'Energy Reduction' for obesity differ from other treatments?

The 'Energy Reduction' treatment for obesity focuses on reducing calorie intake, which can be done through moderate or severe caloric restriction. This approach is unique because it emphasizes the amount of energy consumed rather than the specific types of nutrients, and it can lead to significant short-term weight loss, although maintaining this loss requires ongoing care and lifestyle changes.111121314

What is the purpose of this trial?

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.

Research Team

GR

Gareth R Dutton, PhD

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

I am between 21 and 75 years old.
Body mass index (BMI) 30-50 kg/m2

Exclusion Criteria

I have had weight loss surgery in the past.
My blood pressure is not higher than 160/100 mm Hg.
I have not had unstable chest pain in the last 6 months.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow either a fixed or variable calorie reduction plan to achieve weight loss

18 months
Regular visits for monitoring and support

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Energy Reduction
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

In a study involving 53 overweight patients, those following a healthy eating diet lost an average of 6.0 kg over 12 weeks, which was significantly more than the 4.2 kg lost by those on an energy prescription diet.
Both dietary approaches resulted in clinically significant weight loss, but the healthy eating diet proved to be more effective, suggesting the need for further research to confirm these findings.
Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic: a pilot study.Taylor, F., Irons, L., Finn, P., et al.[2007]
In a study involving 53 overweight patients, those following a healthy eating diet lost an average of 6.0 kg over 12 weeks, which was significantly more than the 4.2 kg lost by those on an energy prescription diet.
Both dietary approaches resulted in clinically significant weight loss, but the healthy eating diet proved to be more effective, suggesting the need for further research to confirm these findings.
Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic - a pilot study.Taylor, FC., Irons, LJ., Finn, P., et al.[2019]
Minor weight loss of 5-10% can significantly reduce health risks associated with obesity, but very low-calorie diets alone are not effective for long-term weight management.
Bariatric surgery is a safe and effective option for morbidly obese patients, especially those with additional cardiovascular risk factors, with adjustable gastric banding being a viable alternative to other surgical methods.
[Overweight. III. Therapeutic strategies for weight reduction].Pijl, H., Meinders, AE.[2006]

References

Session 3 (Joint with the British Dietetic Association): Management of obesity: Weight-loss interventions in the treatment of obesity. [2013]
Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic: a pilot study. [2007]
Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic - a pilot study. [2019]
Resting energy expenditure of morbidly obese patients using indirect calorimetry: a systematic review. [2018]
Nutritional Therapy. [2016]
[Overweight. III. Therapeutic strategies for weight reduction]. [2006]
Dietary supplements and alternative therapies for obesity: A Perspective from The Obesity Society's Clinical Committee. [2021]
Medical therapy for obesity--current status and future hopes. [2007]
The safety profiles of orlistat and sibutramine: results of prescription-event monitoring studies in England. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Food intake of very obese persons: quantitative and qualitative aspects. [2007]
11.United Statespubmed.ncbi.nlm.nih.gov
Treatment of obesity by moderate and severe caloric restriction. Results of clinical research trials. [2019]
Different dietary strategies for weight loss in obesity: role of energy and macronutrient content. [2008]
13.United Statespubmed.ncbi.nlm.nih.gov
Reducing Calorie Intake May Not Help You Lose Body Weight. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Low-calorie diets and sustained weight loss. [2007]
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