Behavioral Therapy for Obesity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Weight loss drugs

Disqualifiers: Sarcopenia, Kidney disease, Eating disorders, others

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

Compensation: Varies

Number of Visits: 36

What You Need to Know Before You Apply

What is the purpose of this trial?

To test adaptive intensive behavioral therapy strategies comprising dietary patterns with varying amounts of protein and including supplemental protein or resistance exercise training for promoting weight loss and attenuating lean mass loss in adults aged 50-75 with obesity.

Who Is on the Research Team?

Drew Sayer, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

Inclusion Criteria

* all racial and ethnic groups

I am between 50 and 75 years old.

I am either male or female.

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

How Is the Trial Designed?

Group I: High Protein Diet Only Active Control 1 Intervention

Enrollment in State of Slim (SOS) weight loss program with a high protein diet. This arm includes participants identified as responders to the high protein diet counseling in stage 1 at the week 8 assessment.

Group II: High Protein Diet + Supplement Active Control 2 Interventions

Enrollment in State of Slim (SOS) weight loss program with a high protein diet. Participants identified as non-responders at the week 8 assessment will receive protein supplements to augment their intervention plan.

Group III: High Protein Diet + Supervised Exercise Active Control 2 Interventions

Enrollment in State of Slim (SOS) weight loss program with a high protein diet. Participants identified as non-responders at the week 8 assessment will receive supervised resistance training sessions to augment their intervention plan.

Group IV: Standard Protein Diet Only Active Control 1 Intervention

Enrollment in State of Slim (SOS) weight loss program with a standard protein diet. This arm includes participants identified as responders to the standard protein diet counseling in stage 1 at the week 8 assessment.

Group V: Standard Protein Diet + Supplement Active Control 2 Interventions

Enrollment in State of Slim (SOS) weight loss program with a standard protein diet. Participants identified as non-responders at the week 8 assessment will receive protein supplements to augment their intervention plan.

Group VI: Standard Protein Diet + Supervised Exercise Active Control 2 Interventions

Enrollment in State of Slim (SOS) weight loss program with a standard protein diet. Participants identified as non-responders at the week 8 assessment will receive supervised resistance training sessions to augment their intervention plan.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+