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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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