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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07446907
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight
  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: High Protein Diet Only
    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.
  • Active Comparator: High Protein Diet + Supplement
    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.
  • Active Comparator: High Protein Diet + Supervised Exercise
    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.
  • Active Comparator: Standard Protein Diet Only
    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.
  • Active Comparator: Standard Protein Diet + Supplement
    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.
  • Active Comparator: Standard Protein Diet + Supervised Exercise
    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.

Primary Outcome Measure

Change in Body Weight [ Time Frame: Baseline, 8 weeks, 16 weeks, 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Drew Sayer, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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