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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
89
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.
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruitment and Retention Rates
Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.
Time frame: Baseline through week 52.
Class Attendance
Class Attendance will be tracked to determine clinical trial feasibility.
Time frame: Baseline through week 52.
1st Stage Treatment Credibility
Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 8
Body Weight
Changes from baseline body weight will be measured at weeks 8, 16, and 52.
Time frame: Baseline, Weeks 8, 16, and 52
Fat mass
Changes from baseline fat mass will be measured at weeks 8, 16, and 52.
Time frame: Baseline, Weeks 8, 16, and 52
Fat free mass
Changes from baseline fat free mass will be measured at weeks 8, 16, and 52.
Time frame: Baseline, Weeks 8, 16, and 52
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