Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07446907

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age50 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Sarcopenia

Full registry criteria

Inclusion Criteria: * Male or female sex * all racial and ethnic groups * BMI: 30-50 kg/m2 * age 50-75 years * postmenopausal status for ≥1 y if female sex Exclusion Criteria: * \<3 months stable use of other medications affecting body weight or appetite * \>450 pounds (due to weight limitations of the DXA) * indication or previous diagnosis of sarcopenia * existing kidney disease * current binge eating disorder, anorexia, or bulimia * untreated hyper- or hypothyroidism, cancer (except basal cell), gastrointestinal disorders affecting food intake or nutrient absorption; any other medical condition, as determined by the study physician, precluding a HP diet and/or daily exercise

Treatments and study arms

High Protein Diet Counceling

Behavioral

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%.

Standard Protein Diet Counceling

Behavioral

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%.

Protein Supplement

Behavioral

Non-responders from either initial randomized group assigned to this intervention receive twice daily protein supplements.

Supervised Exercise

Behavioral

Non-responders from either initial randomized group assigned to this intervention receive twice weekly small-group supervised resistance exercise training sessions.

Primary outcomes

Change in Body WeightBaseline, 8 weeks, 16 weeks, 52 weeks

Participants will be weighed at baseline through 52 weeks

Change in Fat Free MassBaseline, 8 weeks, 16 weeks, 52 weeks

Participants will be scanned via DXA scan to measure overall fat free body mass

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Alabama at Birmingham🇺🇸 Birmingham, Alabama, United States

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Drew Sayer, MDPrincipal Investigator