Obesity & OverweightNCT07446907
Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood
A study testing High Protein Diet Counceling, Standard Protein Diet Counceling and Protein Supplement in people with Obesity & Overweight and Sarcopenia, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Obesity & Overweight, Sarcopenia
- What is being tested?
- High Protein Diet Counceling, Standard Protein Diet Counceling and Protein Supplement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Drew Sayer, MD
About this study
Official title: Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood: A Sequential Multiple Assignment Randomized Trial
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.
Read the detailed description
This Sequential Multiple Assignment Randomized Trial (SMART) seeks to identify the optimal initial dietary strategy (high vs. standard protein diets) and as-needed augmentation strategy (protein supplementation vs. supervised resistance exercise training) for behavioral weight loss in adults aged 50-75. Augmentation strategies will only be used for participants who do not achieve at least 3% weight loss and/or those who lose more than 1.5 kg of fat free mass (i.e., Non-Responders) after 8 weeks of group-based behavioral obesity treatment. Protein supplements and supervised resistance exercise training will be provided at no-cost to participants for weeks 9-16 of the study. Responders (i.e., achieving at least 3% weight loss and less than 1.5 kg loss of fat free mass) will continue with their initial high protein or standard protein diet assignment for the remainder of the trial. This SMART will enroll 250 adults aged 50-75 years with a BMI of at least 30 kg/m2. All participants will receive 1 year of behavioral obesity treatment including 16 weeks of weekly group-based treatment (active weight loss phase) followed by 36 weeks of monthly group sessions to promote continued engagement in dietary and exercise behaviors and long-term weight loss maintenance. The behavioral intervention will be delivered via Zoom. Data collection will occur at the University of Alabama at Birmingham and 5 study visits will be scheduled including: screening (to determine eligibility), prior to starting the weight loss intervention (baseline), and at weeks 8, 16, and 52.
- Conditions
- Obesity & Overweight, Sarcopenia
- Being tested
- High Protein Diet Counceling, Standard Protein Diet Counceling, Protein Supplement, Supervised Exercise
- Keywords
- Obesity, Sarcopenia
- Medical subject headings
- Obesity, Overweight, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein Diet CouncelingBehavioural
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 CouncelingBehavioural
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 SupplementBehavioural
Non-responders from either initial randomized group assigned to this intervention receive twice daily protein supplements.
Supervised ExerciseBehavioural
Non-responders from either initial randomized group assigned to this intervention receive twice weekly small-group supervised resistance exercise training sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Standard Protein Diet Counceling; Behavioral: Supervised Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Participants will be weighed at baseline through 52 weeks
Measured: 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
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Secondary outcomes (11)
Change in Fat Mass
Participants will be scanned via DXA scan to measure overall fat mass
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Glucose
Participants will have a blood draw to check fasting blood sugar levels
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Insulin
Participants will have a blood draw to check fasting insulin levels
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Hemoglobin A1C
Participants will have a blood draw to check fasting A1C levels
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting LDL-cholesterol
Participants will have a blood draw to check fasting LDL-cholesterol levels
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting HDL-cholesterol
Participants will have a blood draw to check fasting HDL-cholesterol levels
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Total Cholesterol
Participants will have a blood draw to check fasting total cholesterol levels
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Total Triglycerides
Participants will have a blood draw to check fasting triglyceride levels
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Blood Pressure
Participants will have a blood pressure check at each appointment
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Hand Grip Strength
Participants will have hand grip strength via the Jamar dynamometer, a tool for assessing and monitoring patients' hand strength. Measurements are based on a scale of 0-90 kilograms of force, where higher numbers indicate more strength.
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Lower Extremity Strength
Participants will be assessed using the Short Physical Performance Battery (SPPB). The SPPB is a commonly-used assessment of lower extremity function in aging adults and used a combined score comprising tests of balance, gait speed, and the chair stand test.
Key Components and Scoring (0-12 points total):
Standing Balance: Evaluates three stances (side-by-side, semi-tandem, tandem) held for 10 seconds each, scored up to 4 points.
Gait Speed: Measures the time taken to walk 3 or 4 meters at a normal pace, scored up to 4 points.
Chair Stands: Measures the time taken to rise from a chair five times without using arms, scored up to 4 points.
Interpretation and Cut-off Scores:
Total Score 0-6: Indicates low performance and high risk for functional decline.
Total Score 7-9: Moderate performance. Total Score 10-12: High performance.
Measured: Baseline, 8 weeks, 16 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startSep 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drew Sayer, University of Alabama at Birmingham
- Investigators
- Drew Sayer, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446907
- Sponsor's protocol ID
- IRB-300016298
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the time of publication(s) related to this trial, a fully de-identified dataset including individual participant data will be made available so that data analysis can be replicated by other investigators. This dataset will be freely available for download as supplemental material to manuscript(s) submitted to PubMed Central.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood: A Sequential Multiple Assignment Randomized Trial
- ClinicalTrials.gov ID
- NCT07446907
- Acronym / sponsor ID
- IRB-300016298
- Conditions
- Obesity & Overweight, Sarcopenia
- Keywords
- Obesity, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Sequential Multiple Assignment Randomized Trial (SMART) seeks to identify the optimal initial dietary strategy (high vs. standard protein diets) and as-needed augmentation strategy (protein supplementation vs. supervised resistance exercise training) for behavioral weight loss in adults aged 50-75. Augmentation strategies will only be used for participants who do not achieve at least 3% weight loss and/or those who lose more than 1.5 kg of fat free mass (i.e., Non-Responders) after 8 weeks of group-based behavioral obesity treatment. Protein supplements and supervised resistance exercise training will be provided at no-cost to participants for weeks 9-16 of the study. Responders (i.e., achieving at least 3% weight loss and less than 1.5 kg loss of fat free mass) will continue with their initial high protein or standard protein diet assignment for the remainder of the trial. This SMART will enroll 250 adults aged 50-75 years with a BMI of at least 30 kg/m2. All participants will receive 1 year of behavioral obesity treatment including 16 weeks of weekly group-based treatment (active weight loss phase) followed by 36 weeks of monthly group sessions to promote continued engagement in dietary and exercise behaviors and long-term weight loss maintenance. The behavioral intervention will be delivered via Zoom. Data collection will occur at the University of Alabama at Birmingham and 5 study visits will be scheduled including: screening (to determine eligibility), prior to starting the weight loss intervention (baseline), and at weeks 8, 16, and 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| High Protein Diet Only | Active comparator | Behavioral: High Protein Diet CouncelingEnrollment 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. |
| High Protein Diet + Supplement | Active comparator | Behavioral: High Protein Diet Counceling, Behavioral: Protein SupplementEnrollment 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. |
| High Protein Diet + Supervised Exercise | Active comparator | Behavioral: High Protein Diet Counceling, Behavioral: Supervised ExerciseEnrollment 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. |
| Standard Protein Diet Only | Active comparator | Behavioral: Standard Protein Diet CouncelingEnrollment 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. |
| Standard Protein Diet + Supplement | Active comparator | Behavioral: Standard Protein Diet Counceling, Behavioral: Protein SupplementEnrollment 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. |
| Standard Protein Diet + Supervised Exercise | Active comparator | Behavioral: Standard Protein Diet Counceling, Behavioral: Supervised ExerciseEnrollment 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Protein Diet Counceling16 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%. | Behavioural | High Protein Diet + Supervised Exercise, High Protein Diet + Supplement, High Protein Diet Only |
| Standard Protein Diet Counceling16 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%. | Behavioural | Standard Protein Diet + Supervised Exercise, Standard Protein Diet + Supplement, Standard Protein Diet Only |
| Protein SupplementNon-responders from either initial randomized group assigned to this intervention receive twice daily protein supplements. | Behavioural | High Protein Diet + Supplement, Standard Protein Diet + Supplement |
| Supervised ExerciseNon-responders from either initial randomized group assigned to this intervention receive twice weekly small-group supervised resistance exercise training sessions. | Behavioural | High Protein Diet + Supervised Exercise, Standard Protein Diet + Supervised Exercise |
Primary outcome
Change in Body Weight
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Participants will be weighed at baseline through 52 weeks
Change in Fat Free Mass
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Participants will be scanned via DXA scan to measure overall fat free body mass
11 secondary outcomes
Change in Fat Mass
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Glucose
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Insulin
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Hemoglobin A1C
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting LDL-cholesterol
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting HDL-cholesterol
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Total Cholesterol
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Fasting Total Triglycerides
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Blood Pressure
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Hand Grip Strength
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Change in Lower Extremity Strength
Time frame: Baseline, 8 weeks, 16 weeks, 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. At the time of publication(s) related to this trial, a fully de-identified dataset including individual participant data will be made available so that data analysis can be replicated by other investigators. This dataset will be freely available for download as supplemental material to manuscript(s) submitted to PubMed Central.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Drew Sayer, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Diet Counceling, Standard Protein Diet Counceling and Protein Supplement in people with Obesity & Overweight and Sarcopenia, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline, 8 weeks, 16 weeks, 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.