NCT07446907

Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood

Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood: A Sequential Multiple Assignment Randomized Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This Sequential Multiple Assignment Randomized Trial (SMART) seeks to identify the optimal initial dietary strategy (high vs. standard protein diets) and as-needed augmentation strategy (protein supplementation vs. supervised resistance exercise training) for behavioral weight loss in adults aged 50-75. Augmentation strategies will only be used for participants who do not achieve at least 3% weight loss and/or those who lose more than 1.5 kg of fat free mass (i.e., Non-Responders) after 8 weeks of group-based behavioral obesity treatment. Protein supplements and supervised resistance exercise training will be provided at no-cost to participants for weeks 9-16 of the study. Responders (i.e., achieving at least 3% weight loss and less than 1.5 kg loss of fat free mass) will continue with their initial high protein or standard protein diet assignment for the remainder of the trial. This SMART will enroll 250 adults aged 50-75 years with a BMI of at least 30 kg/m2. All participants will receive 1 year of behavioral obesity treatment including 16 weeks of weekly group-based treatment (active weight loss phase) followed by 36 weeks of monthly group sessions to promote continued engagement in dietary and exercise behaviors and long-term weight loss maintenance. The behavioral intervention will be delivered via Zoom. Data collection will occur at the University of Alabama at Birmingham and 5 study visits will be scheduled including: screening (to determine eligibility), prior to starting the weight loss intervention (baseline), and at weeks 8, 16, and 52.

Conditions

• Obesity & Overweight
• Sarcopenia

Interventions

Type	Name	Description
BEHAVIORAL	High Protein Diet Counceling	16 week group-based weight loss program with counseling to consume a high protein diet. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.
BEHAVIORAL	Standard Protein Diet Counceling	16 week group-based weight loss program with counseling to consume a standard protein diet. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:20%:27%.
BEHAVIORAL	Protein Supplement	Non-responders from either initial randomized group assigned to this intervention receive twice daily protein supplements.
BEHAVIORAL	Supervised Exercise	Non-responders from either initial randomized group assigned to this intervention receive twice weekly small-group supervised resistance exercise training sessions.

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-03-31
• Completion: 2031-03-31
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States