Diet and Exercise Approaches for Weight Loss in Older Adults With Obesity
Tests protein diets, protein supplements and exercise for weight loss in older adults with obesity.
Key facts
- Who runs it
- University of Alabama at Birmingham
- Where
- Birmingham, United StatesSee the site
- Trial code
- Registry title
- Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood
- Status
- Not yet recruiting
- People taking part
- 250 people, planned
- Started
- Sept 2026
- Expected to end
- 30 Jun 2031
- Type of study
- Interventional, 6 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- High Protein Diet Counceling
- Standard Protein Diet Counceling
- Protein Supplement
- Supervised Exercise
- Record updated
- 3 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 to 75 who have obesity (BMI 30-50 kg/m2). It tests diet and exercise programs for weight loss while keeping muscle.
- Age
- 50 to 75 years
- Sex
- Men and women. Women must have been postmenopausal for at least 1 year.
- Disease stage
- Obesity with a BMI of 30-50 kg/m2.
- Earlier treatment
- People who use other medicines that affect body weight or appetite must have used them in a stable way for at least 3 months.
Main reasons for not taking part
- Weight over 450 pounds (204 kg)
- Sarcopenia, now or diagnosed before
- Existing kidney disease
- Current binge eating disorder, anorexia or bulimia
- Untreated thyroid problems, cancer (except basal cell), or gut disorders that affect eating or nutrient absorption
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- <3 months stable use of other medications affecting body weight or appetite
- 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
- >450 pounds (due to weight limitations of the DXA)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 75 years old?
Where in United States
- University of Alabama at BirminghamBirmingham, United StatesContact: Drew Sayer, MD (principal investigator)No longer taking part
About the trial
What the trial wants to find out
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.
The 6 groups in the trial
- High Protein Diet OnlyExisting treatment, for comparison
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.
Treatment: High Protein Diet Counceling
- High Protein Diet + SupplementExisting treatment, for comparison
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.
Treatment: High Protein Diet Counceling and Protein Supplement
- High Protein Diet + Supervised ExerciseExisting treatment, for comparison
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.
Treatment: High Protein Diet Counceling and Supervised Exercise
- Standard Protein Diet OnlyExisting treatment, for comparison
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.
Treatment: Standard Protein Diet Counceling
- Standard Protein Diet + SupplementExisting treatment, for comparison
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.
Treatment: Standard Protein Diet Counceling and Protein Supplement
- Standard Protein Diet + Supervised ExerciseExisting treatment, for comparison
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.
Treatment: Standard Protein Diet Counceling and Supervised Exercise
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood: A Sequential Multiple Assignment Randomized Trial
- Plain-language title
- Diet and Exercise Approaches for Weight Loss in Older Adults With ObesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07446907, who can take part
- Record updated
- 3 August 2026