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

NCT07446907 | Not Yet Recruiting

• 1 other identifier: IRB-300016298
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight; Sarcopenia

Keywords

Obesity; Sarcopenia

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight

  Participants will be weighed at baseline through 52 weeks

  Baseline, 8 weeks, 16 weeks, 52 weeks

• Change in Fat Free Mass

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

  Baseline, 8 weeks, 16 weeks, 52 weeks

Secondary Outcomes (11)

• Change in Fat Mass

  Baseline, 8 weeks, 16 weeks, 52 weeks

• Change in Fasting Glucose

  Baseline, 8 weeks, 16 weeks, 52 weeks

• Change in Fasting Insulin

  Baseline, 8 weeks, 16 weeks, 52 weeks

• Change in Fasting Hemoglobin A1C

  Baseline, 8 weeks, 16 weeks, 52 weeks

• Change in Fasting LDL-cholesterol

  Baseline, 8 weeks, 16 weeks, 52 weeks

Study Arms (6)

High Protein Diet Only

ACTIVE COMPARATOR

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.

Behavioral: High Protein Diet Counceling

High Protein Diet + Supplement

ACTIVE COMPARATOR

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.

Behavioral: High Protein Diet Counceling; Behavioral: Protein Supplement

High Protein Diet + Supervised Exercise

ACTIVE COMPARATOR

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.

Behavioral: High Protein Diet Counceling; Behavioral: Supervised Exercise

Standard Protein Diet Only

ACTIVE COMPARATOR

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.

Behavioral: Standard Protein Diet Counceling

Standard Protein Diet + Supplement

ACTIVE COMPARATOR

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.

Behavioral: Standard Protein Diet Counceling; Behavioral: Protein Supplement

Standard Protein Diet + Supervised Exercise

ACTIVE COMPARATOR

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.

Behavioral: Standard Protein Diet Counceling; Behavioral: Supervised Exercise

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%.

High Protein Diet + Supervised Exercise; High Protein Diet + Supplement; High Protein Diet Only

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%.

Standard Protein Diet + Supervised Exercise; Standard Protein Diet + Supplement; Standard Protein Diet Only

Protein Supplement BEHAVIORAL

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

High Protein Diet + Supplement; Standard Protein Diet + Supplement

Supervised Exercise BEHAVIORAL

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

High Protein Diet + Supervised Exercise; Standard Protein Diet + Supervised Exercise

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Sarcopenia

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Drew Sayer, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Sequential Multiple Assignment Randomized Trial (SMART)

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available at the time of publication of manuscripts associated with this trial.
• Access Criteria: Freely available for download from PubMed Central as supplemental material to associated manuscripts.

Locations

US (1)