Behavioral Therapy for Obesity

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests various strategies to help adults aged 50-75 with obesity lose weight while maintaining muscle mass. Participants will follow either a high-protein or standard-protein diet. Some may also receive protein supplements or engage in supervised exercise if they need additional support after eight weeks. The goal is to identify the most effective combination of diet, supplements, and exercise for weight loss. Individuals with a BMI (body mass index) between 30 and 50 who have struggled with weight are well-suited for this trial. As an unphased trial, it offers participants the chance to contribute to innovative weight management strategies.

Do I need to stop my current medications for the trial?

The trial requires that you have been on stable use of medications affecting body weight or appetite for at least 3 months. If your current medications affect weight or appetite and have not been stable for 3 months, you may need to adjust them before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that high-protein diets are safe for healthy individuals. These diets can aid in weight loss and improve heart health. Some studies found that high-protein diets result in better weight loss than standard diets. However, a high-protein diet might not suit everyone, as it can cause weight gain in some individuals.

Research has shown that protein supplements can assist in weight loss and help maintain muscle. They are generally safe, but some individuals might experience digestive issues. Choosing supplements carefully is important, as some may contain harmful substances like heavy metals.

Studies have indicated that standard protein diets are also generally safe. They can support weight loss, though sometimes not as effectively as high-protein diets.

Supervised exercise is safe and effective for weight loss and health improvement. Supervision helps individuals adhere to their exercise routines and achieve better results.

Overall, these treatments are well-tolerated, but individual experiences may vary. Discuss any concerns with a healthcare provider.12345

Why are researchers excited about this trial?

Researchers are excited about the behavioral therapy for obesity trial because it explores personalized approaches to weight loss that go beyond typical diet and exercise plans. The trial is unique in its use of a high protein diet coupled with either protein supplements or supervised exercise for participants who do not initially respond. This personalized augmentation could lead to more effective and sustained weight loss compared to standard treatments. Additionally, identifying responders early and tailoring interventions could optimize outcomes, making weight management more efficient and potentially more successful.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that high-protein diets, which participants in this trial may receive, can significantly aid in weight loss and body fat reduction. For instance, one study found that participants lost about 8 pounds and reduced their body fat by around 7 pounds after six months. In this trial, some participants will receive protein supplements to potentially help maintain muscle while losing weight. Studies on whey protein supplements have demonstrated their ability to boost weight loss and improve muscle health. Additionally, some participants will engage in supervised exercise, such as weight training, which can enhance weight loss and muscle strength when combined with dietary changes. Regular protein diets, another option in this trial, can also effectively lead to noticeable weight loss and a smaller waist.12678

Who Is on the Research Team?

DS

Drew Sayer, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-75 with obesity (BMI between 30 and 50). Women must be postmenopausal for at least one year. People of all racial and ethnic backgrounds can join.

Inclusion Criteria

* all racial and ethnic groups
I am between 50 and 75 years old.
I am either male or female.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Baseline assessments including DXA scans and blood draws to measure various health metrics

1 week
1 visit (in-person)

Active Weight Loss Phase

Participants receive weekly group-based behavioral obesity treatment with dietary interventions

16 weeks
16 visits (virtual)

Augmentation Phase

Non-responders receive protein supplements or supervised resistance exercise training

8 weeks
8 visits (virtual)

Maintenance Phase

Monthly group sessions to promote continued engagement in dietary and exercise behaviors

36 weeks
9 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • High Protein Diet Counseling
  • Protein Supplement
  • Standard Protein Diet Counseling
  • Supervised Exercise

Trial Overview

The study compares different weight loss strategies: high-protein diet counseling, standard protein diet counseling, protein supplements, and supervised exercise. The goal is to help participants lose weight while keeping muscle mass.

How Is the Trial Designed?

6

Treatment groups

Active Control

Group I: High Protein Diet OnlyActive Control1 Intervention
Group II: High Protein Diet + SupplementActive Control2 Interventions
Group III: High Protein Diet + Supervised ExerciseActive Control2 Interventions
Group IV: Standard Protein Diet OnlyActive Control1 Intervention
Group V: Standard Protein Diet + SupplementActive Control2 Interventions
Group VI: Standard Protein Diet + Supervised ExerciseActive Control2 Interventions

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+

Citations

Clinical Evidence and Mechanisms of High-Protein Diet ... - PMC

After 6 months, participants in the high-protein group significantly lost BW (–3.7 kg; 95% CI, –6.2 to –1.3 kg) and fat mass (–3.3 kg; 95% CI, –5.5 to –1.1 kg) ...

Effect of a High-Protein Diet versus Standard ... - PMC - NIH

Some studies have shown that protein-enriched diets can lead to greater weight loss and improvements in biomarkers of metabolic syndrome (MeS) than standard ...

Effectiveness of High Protein Diets in Promoting Weight ...

Several studies have reported greater weight loss when following high meat-protein diets but limited studies have studied high plant-based protein diets. Thus ...

High-Protein, Low-Fat Diets Are Effective for Weight Loss ...

Both diets were equally effective at reducing body weight (−6%, P < 0.05) and fat mass (−9 to −11%, P < 0.05); however, subjects consuming the high-protein diet ...

Higher Protein Intake While Dieting Leads to Healthier Eating

Eating a larger proportion of protein while dieting leads to better food choices and helps avoid the loss of lean body mass, according to a Rutgers study.

High-protein diets: Are they safe?

Diets high in protein aren't known to cause medical problems in healthy people. But there are a wide range of these types of diets.

The harms of high protein intake: conjectured, postulated, ...

In this paper, we discuss several of the postulated harms cited in academic and lay publications and investigate the strength of evidence to support or refute ...

High-protein diets: are they really safe and effective?

This review focuses on the impact of high-protein diets on weight loss, body composition, cardiovascular risk, glycemic control, renal function and urinary ...