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The purpose of this study is to examine the separate and combined effects of a high-protein (HP) diet and resistance training (RT) on body composition and potential biological moderators of body weight in women and men >50y. All participants will receive dietary physical activity guidance through our group-based weight loss program, State of Slim (SOS). The SOS program will be delivered via the Zoom videoconferencing platform. These participants will be randomized to receive either a counseling-based HP diet plan or RT plan. Body composition assessments at 8 wk will identify responders and non-responders; the latter will be re-randomized to "augment" (HP: add protein supplements; RT: supervise RT) or "combine" (HP with protein supplements + supervised RT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Protein Diet | Experimental | Enrollment in State of Slim (SOS) weight loss program with a high protein diet. |
|
| Resistance Training | Experimental | Enrollment in State of Slim (SOS) weight loss program with resistance training counseling sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Protein Diet | Behavioral | 16 week group-based weight loss program with high protein diet. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed after 8 weeks. Non-responders will be randomized to either combine the HP diet with supervised resistance training counseling (2 days per week) or add a protein supplement. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment and Retention Rates | Rates of study recruitment and retention will be tracked to determine clinical trial feasibility. | Baseline through week 52. |
| Class Attendance | Class Attendance will be tracked to determine clinical trial feasibility. | Baseline through week 52. |
| 1st Stage Treatment Credibility | Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire. | Baseline. |
| 2nd Stage Treatment Credibility | Perceived credibility of 2nd stage interventions will be measured in non-responders to 1st stage interventions at week 8 with the Credibility/Expectancy Questionnaire. | Week 8. |
| 1st Stage Intervention Preference | Participant preferences for 1st stage interventions will be measured at baseline by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference. | Baseline |
| 2nd Stage Intervention Preference | Participant preferences for 2nd stage interventions will be measured at week 8 by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Changes from baseline body weight will be measured at weeks 8, 16, and 52. | Baseline, Weeks 8, 16, and 52 |
| Fat mass | Changes from baseline fat mass will be measured at weeks 8, 16, and 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose | Serum glucose will be measured in a fasted state and after a glucose load [mg/dL] | Baseline to Weeks 8, 16, and 52 |
| Change in insulin | Serum insulin will be measured in a fasted state and after a glucose load, measured in micro-units/milliliter [uU/mL] |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Drew Sayer, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3360 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 25, 2025 | |
| Reset | Jul 15, 2025 | |
| Release | Aug 12, 2025 | |
| Reset | Aug 29, 2025 | |
| Release | Sep 23, 2025 | |
| Reset | Oct 10, 2025 | |
| Release | Oct 14, 2025 | |
| Reset | Oct 27, 2025 | |
| Release | Nov 19, 2025 | |
| Reset | Dec 12, 2025 | |
| Release | Jan 9, 2026 | |
| Reset | Jan 28, 2026 | |
| Release | Apr 23, 2026 | |
| Reset | May 15, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 25, 2025 | Jul 15, 2025 | |||
| Aug 12, 2025 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
| Resistance Training | Behavioral | 16 week weight loss program with normal protein diet and resistance training counseling. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:20%:26%. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed after 8 weeks. Non-responders will be randomized to either combine resistance training with HP/protein supplement or add supervised sessions with a personal trainer (2 days per week) to the resistance training regimen. |
|
| Baseline, Weeks 8, 16, and 52 |
| Fat free mass | Changes from baseline fat free mass will be measured at weeks 8, 16, and 52. | Baseline, Weeks 8, 16, and 52 |
| Baseline to Weeks 8, 16, and 52 |
| Changes in lipids | Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides | Baseline to Weeks 8, 16, and 52 |
| Changes in disposition index | Derived from Oral Glucose Tolerance Test (OGTT) using 0 minute and 30 minute time-points. | Baseline to Weeks 8, 16, and 52 |
| Changes in aerobic fitness | 6-Minute Walk test for ambulatory participants OR 6-Minute Push test for wheelchair users. | Baseline to Weeks 8, 16, and 52 |
| Changes in physical activity | 7-day accelerometry | Baseline to Weeks 8, 16, and 52 |
| Aug 29, 2025 |
| Sep 23, 2025 | Oct 10, 2025 |
| Oct 14, 2025 | Oct 27, 2025 |
| Nov 19, 2025 | Dec 12, 2025 |
| Jan 9, 2026 | Jan 28, 2026 |
| Apr 23, 2026 | May 15, 2026 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |