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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fat Mass | Participants will be scanned via DXA scan to measure overall fat mass | Baseline, 8 weeks, 16 weeks, 52 weeks |
| Change in Fasting Glucose | Participants will have a blood draw to check fasting blood sugar levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Drew Sayer, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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.
IPD and supporting information will be available at the time of publication of manuscripts associated with this trial.
Freely available for download from PubMed Central as supplemental material to associated manuscripts.
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Sequential Multiple Assignment Randomized Trial (SMART)
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| 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. |
|
| 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. |
|
| 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. |
|
| Baseline, 8 weeks, 16 weeks, 52 weeks |
| Change in Fasting Insulin | Participants will have a blood draw to check fasting insulin levels | Baseline, 8 weeks, 16 weeks, 52 weeks |
| Change in Fasting Hemoglobin A1C | Participants will have a blood draw to check fasting A1C levels | Baseline, 8 weeks, 16 weeks, 52 weeks |
| Change in Fasting LDL-cholesterol | Participants will have a blood draw to check fasting LDL-cholesterol levels | Baseline, 8 weeks, 16 weeks, 52 weeks |
| Change in Fasting HDL-cholesterol | Participants will have a blood draw to check fasting HDL-cholesterol levels | Baseline, 8 weeks, 16 weeks, 52 weeks |
| Change in Fasting Total Cholesterol | Participants will have a blood draw to check fasting total cholesterol levels | Baseline, 8 weeks, 16 weeks, 52 weeks |
| Change in Fasting Total Triglycerides | Participants will have a blood draw to check fasting triglyceride levels | Baseline, 8 weeks, 16 weeks, 52 weeks |
| Change in Blood Pressure | Participants will have a blood pressure check at each appointment | 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. | 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. | Baseline, 8 weeks, 16 weeks, 52 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
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