Weight Loss in Adults Over 50 With Obesity
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: High Protein Diet Enrollment in State of Slim (SOS) weight loss program with a high protein diet. |
Behavioral: High Protein Diet
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.
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Experimental: Resistance Training Enrollment in State of Slim (SOS) weight loss program with resistance training counseling sessions. |
Behavioral: Resistance Training
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.
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Outcome Measures
Primary Outcome Measures
- Recruitment and Retention Rates [Baseline through week 52.]
Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.
- Class Attendance [Baseline through week 52.]
Class Attendance will be tracked to determine clinical trial feasibility.
- 1st Stage Treatment Credibility [Baseline.]
Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.
- 2nd Stage Treatment Credibility [Week 8.]
Perceived credibility of 2nd stage interventions will be measured in non-responders to 1st stage interventions at week 8 with the Credibility/Expectancy Questionnaire.
- 1st Stage Intervention Preference [Baseline]
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.
- 2nd Stage Intervention Preference [Week 8]
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.
Secondary Outcome Measures
- Body Weight [Baseline, Weeks 8, 16, and 52]
Changes from baseline body weight will be measured at weeks 8, 16, and 52.
- Fat mass [Baseline, Weeks 8, 16, and 52]
Changes from baseline fat mass will be measured at weeks 8, 16, and 52.
- Fat free mass [Baseline, Weeks 8, 16, and 52]
Changes from baseline fat free mass will be measured at weeks 8, 16, and 52.
Other Outcome Measures
- Change in glucose [Baseline to Weeks 8, 16, and 52]
Serum glucose will be measured in a fasted state and after a glucose load [mg/dL]
- Change in insulin [Baseline to Weeks 8, 16, and 52]
Serum insulin will be measured in a fasted state and after a glucose load, measured in micro-units/milliliter [uU/mL]
- Changes in lipids [Baseline to Weeks 8, 16, and 52]
Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
- Changes in disposition index [Baseline to Weeks 8, 16, and 52]
Derived from Oral Glucose Tolerance Test (OGTT) using 0 minute and 30 minute time-points.
- Changes in aerobic fitness [Baseline to Weeks 8, 16, and 52]
6-Minute Walk test for ambulatory participants OR 6-Minute Push test for wheelchair users.
- Changes in physical activity [Baseline to Weeks 8, 16, and 52]
7-day accelerometry
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or Female
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Age ≥50 years
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Post-menopausal if Female
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BMI of 30-50 kg/m2 for ambulatory participants (less than or equal to 350 lbs.)
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BMI of 25-50 kg/m2 for wheelchair users (less than or equal to 350 lbs.)
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Ambulatory with or without a walking device or use of a manual wheelchair for mobility.
Exclusion Criteria:
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Untreated hyper or hypothyroidism.
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Cancer (except basal cell).
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Gastrointestinal disorders affecting food intake.
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<3 months of stable use of medications that affect metabolism, body weight, energy expenditure or appetite.
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Current eating disorder (e.g., binge eating disorder, anorexia, or bulimia).
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Any medical condition for which following a HP diet and/or 70 minutes of exercise daily would be inadvisable.
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Uses a powered wheelchair for mobility.
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Has a pacemaker or any other life-sustaining medical implant.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294-3360 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Drew Sayer, PhD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300003818