Protein and Resistance Exercise to Stop Sarcopenic Obesity Now

NCT04014296 | Completed Results

• 2 other identifiers: IRB-300003818K01DK124244
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

weight loss; dietary protein; exercise training; fat free mass

Outcome Measures

Primary Outcomes (7)

• Recruitment Rates

  Rates of study recruitment will be tracked to determine clinical trial feasibility. Outcome measures are determined by the percentage of people who were originally assessed for eligibility by phone (n=469) and advanced to the next stage of recruitment.

  Screening through randomization, up to 6 months.

• Retention Rate (Percentage of Participants Completing Week 16 Assessment)

  Retention rate is defined as the percentage of randomized participants who completed the Week 16 assessment, calculated as (number completing the Week 16 assessment divided by number randomized at baseline) x 100. In this pre-specified study outcome, retention rates are summarized by Stage 1 intervention arm.

  Baseline through week 16.

• Class Attendance

  Average percent of scheduled group classes attended per participant from baseline to week 16, calculated as (number of sessions attended ÷ number of sessions offered) × 100.

  Baseline through week 16.

• Stage 1 Treatment Credibility

  Perceived credibility of Stage 1 interventions to produce weight loss will be measured at baseline (before responder/non-responders are identified) with the Credibility/Expectancy Questionnaire. Credibility is assessed by answering 3 questions and using a 9-point Likert scale with values ranging from 1: Not at all logical/useful/confident to 9: Very logical/useful/confident. Scores are summed across items to create a total credibility score ranging from 3 to 27, with higher scores indicating greater perceived credibility.

  Baseline

• Stage 2 Treatment Credibility

  Perceived credibility of Stage 2 interventions to produce weight loss will be measured at Week 8 with the Credibility/Expectancy Questionnaire. Credibility is assessed by answering 3 questions and using a 9-point Likert scale with values ranging from 1: Not at all logical/useful/confident to 9: Very logical/useful/confident. Scores are summed across items to create a total credibility score ranging from 3 to 27, with higher scores indicating greater perceived credibility.

  Week 8

• Stage 1 Intervention Preference

  Participant preferences for Stage 1 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. Only participants who completed the survey were analyzed.

  Baseline

• Stage 2 Intervention Preference

  Participant preferences for Stage 2 interventions ("Intensify" versus "Combine") 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. Only non-responders were asked to complete the questionnaire at this stage.

  Week 8

Secondary Outcomes (9)

• Body Weight: Least Squares Mean Change From Baseline to Week 16 (Stage 1 Main Effect: HP vs RT; All Participants)

  Baseline to Week 16

• Body Weight: Least Squares Mean Change From Baseline to Week 16 (Stage 2 Main Effect: Combine vs Intensify; Non-Responders)

  Baseline to Week 16

• Body Weight: Least Squares Mean Change From Baseline to Week 16 (Embedded Adaptive Interventions)

  Baseline to Week 16

• Fat Mass: Least Squares Mean Change From Baseline to Week 16 (Stage 1 Main Effect: HP vs RT; All Participants)

  Baseline to week 16

• Fat Mass: Least Squares Mean Change From Baseline to Week 16 (Stage 2 Main Effect: Combine vs Intensify; Non-Responders)

  Baseline to week 16

Study Arms (6)

High Protein Diet Counseling, Add Protein Supplement for Non-Responders (Intensify)

EXPERIMENTAL

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.

Behavioral: High Protein Diet Counseling; Behavioral: Intensify Initial Intervention

Resistance Training Counseling, Supervised Resistance Training for Non-Responders (Intensify)

EXPERIMENTAL

Enrollment in State of Slim (SOS) weight loss program with resistance training counseling sessions. Participants identified as non-responders at the week 8 assessment will receive supervised resistance exercise training sessions to augment their intervention plan.

Behavioral: Resistance Training Counseling; Behavioral: Intensify Initial Intervention

High Protein Diet Counseling, Combine Protein and Resistance Training for Non-Responders

EXPERIMENTAL

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 and supervised resistance training sessions to augment their intervention plan.

Behavioral: High Protein Diet Counseling; Behavioral: Combined Supplement and Supervised Resistance Training

Resistance Training Counseling, Combine Protein and Resistance Training for Non-Responders

EXPERIMENTAL

Enrollment in State of Slim (SOS) weight loss program with resistance training counseling sessions. Participants identified as non-responders at the week 8 assessment will receive protein supplements and supervised resistance training sessions to augment their intervention plan.

Behavioral: Resistance Training Counseling; Behavioral: Combined Supplement and Supervised Resistance Training

High Protein Diet Counseling, Responder

EXPERIMENTAL

Enrolled in the State of Slim (SOS) weight loss program with counseling to consume a high protein. Met the criteria as a responder at the week 8 assessment and did not receive any second stage augmentation strategy.

Behavioral: High Protein Diet Counseling

Resistance Training Counseling, Responder

EXPERIMENTAL

Enrolled in the State of Slim (SOS) weight loss program with counseling to engage in a full-body resistance exercise training program. Met the criteria as a responder at the week 8 assessment and did not receive any second stage augmentation strategy.

Behavioral: Resistance Training Counseling

Interventions

High Protein Diet Counseling 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%.

High Protein Diet Counseling, Add Protein Supplement for Non-Responders (Intensify); High Protein Diet Counseling, Combine Protein and Resistance Training for Non-Responders; High Protein Diet Counseling, Responder

Resistance Training Counseling BEHAVIORAL

16 week weight loss program with resistance training counseling. Participants receive counseling to follow a full-body and progressive resistance exercise training program using resistance bands that are provided by the study.

Resistance Training Counseling, Combine Protein and Resistance Training for Non-Responders; Resistance Training Counseling, Responder; Resistance Training Counseling, Supervised Resistance Training for Non-Responders (Intensify)

Intensify Initial Intervention BEHAVIORAL

For non-responding participants initially assigned to receive high-protein dietary counseling, whey protein supplements will be provided to participants with instruction to consume the supplement twice daily. For non-responding participants initially assigned to receive resistance exercise training, participants will receive 2 days per week of small-group supervised resistance exercise training.

High Protein Diet Counseling, Add Protein Supplement for Non-Responders (Intensify); Resistance Training Counseling, Supervised Resistance Training for Non-Responders (Intensify)

Combined Supplement and Supervised Resistance Training BEHAVIORAL

Non-responders from either initial randomized group assigned to this intervention receive the twice daily protein supplements and twice weekly small-group supervised resistance exercise training sessions.

High Protein Diet Counseling, Combine Protein and Resistance Training for Non-Responders; Resistance Training Counseling, Combine Protein and Resistance Training for Non-Responders

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Age ≥50 years
• Post-menopausal if Female
• BMI of 30-50 kg/m2 for ambulatory participants (less than or equal to 350 lbs.)
• BMI of 25-50 kg/m2 for wheelchair users (less than or equal to 350 lbs.)
• Ambulatory with or without a walking device or use of a manual wheelchair for mobility.

You may not qualify if:

• Untreated hyper or hypothyroidism.
• Cancer (except basal cell).
• Gastrointestinal disorders affecting food intake.
• \<3 months of stable use of medications that affect metabolism, body weight, energy expenditure or appetite.
• Current eating disorder (e.g., binge eating disorder, anorexia, or bulimia).
• Any medical condition for which following a HP diet and/or 70 minutes of exercise daily would be inadvisable.
• Uses a powered wheelchair for mobility.
• Has a pacemaker or any other life-sustaining medical implant.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• UAB Nutrition Obesity Research Center: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3360, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Limitations and Caveats

This was a pilot Sequential Multiple Assignment Randomized Trial (SMART), and the primary outcomes relate to the feasibility of conducting a full-scale SMART (i.e., recruitment, retention, attendance, credibility, and preference). Secondary outcomes related to body weight and composition should not be considered as confirmatory as the study was not statistically powered for comparative analyses.

Results Point of Contact

• Title: Dr. Drew Sayer
• Organization: University of Alabama at Birmingham

sayerd@uab.edu

205-354-8950

Study Officials

• Drew Sayer, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: This is a pilot Sequential Multiple Assignment Randomized Trial

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 10, 2019
• Study Start: April 12, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: September 22, 2026
• Results First Posted: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)