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ObesityPRESS ONNCT04014296

Protein and Resistance Exercise to Stop Sarcopenic Obesity Now

A study testing High Protein Diet Counseling, Resistance Training Counseling and Intensify Initial Intervention in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
High Protein Diet Counseling, Resistance Training Counseling and Intensify Initial Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteUnited States
Study dates
12 Apr 2021to 31 May 2024
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3360

Other trials in United States

About this study

Official title: Effects of Dietary Protein Intake and Resistance Training on Retention of Fat Free Mass During Weight Loss in Adults Over 50 With Obesity

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).

Read the detailed description

This is a sequential multiple assignment randomized trial (SMART) experimental design. Study testing took place at the University of Alabama at Birmingham (UAB) Wellness, Health, and Research Facility (WHARF) on the Lakeshore Foundation Campus in Birmingham, Alabama.

Overview of the State of Slim Weight Management Program All study participants will be enrolled in the SOS weight management program. SOS is a 16-week group-based behavioral weight loss program (up to 20 per group). The usual SOS diet plan is HP, low in fat and emphasizes non-starchy vegetable and whole-grain carbohydrates. The diet is plan is structured into 3 distinct phases with phase-specific food choices from which participants can chose to eat in defined portions rather than counting calories. Phase 1 is 2 weeks long, Phase 2 is 6 weeks, and Phase 3 is 8 weeks, and additional foods are added to the food choices as participants complete each phase. The SOS diet plan utilizes 5 'Diet Rules' through all 3 phases of the diet to encourage weight loss: (i) Eat 6 times per day; (ii) Have breakfast within 1 h of waking; (iii) Don't count calories, measure portions; (iv) Have the right carbohydrate and protein mix at every meal (1 carbohydrate and 1 protein at every meal, vegetables as only carbohydrate source at 3 meals); and (v) Eat a healthy fat twice a day. SOS also includes a strong exercise component with a prescription to exercise on 6 days per week and to progressively increase exercise duration from 10 min/d to 70 min/d. Participants in the commercial SOS program are encouraged to reach the goal of 420 weekly minutes of exercise through any combination of aerobic, strength, and alternative (e.g., yoga, Pilates, flexibility, balance) exercise training. Weekly group sessions cover topics related to weight management and behavior change such as building motivation, managing stress, practicing new habits, and finding social support.

Research Modifications to State of Slim For this study, participants were randomly assigned to the HP group follow the unmodified SOS diet plan in the published book whereas participants assigned to the RT group follow a modified version (described below) with 3 days per week of self-direct RT that will contribute ~135 minutes per week (45 min/session) to the 420 minutes per week exercise goal (RT group). The 1st and 2nd stage SMART interventions for each group are described below. All participants had access to the online SOS community during the entire study where they could interact/connect with other participants from their group and also have access to the coach who will be available to provide information and answer questions. The SOS community is a private Facebook group that is only open to participants in that specific SOS group.

First-Stage Interventions- High Protein Diet Counseling Participants in this group followed the usual SOS diet. The estimated macronutrient distribution is 40% protein (or ~1.8 g/kg body weight/d), 32% carbohydrate, and 28% fat. Prior to the start of the intervention, participants completed a virtual orientation session with a personal trainer via zoom who demonstrated a sequence of balance and flexibility exercises (single limb stance, heel-to-toe walk, standing side leg raise, standing back leg raise). Participants were instructed to engage in this sequence and any other balance and flexibility exercises (i.e., yoga, Pilates etc.) for approximately 45 minutes per day that contributed to the overall 420 minutes per week and to avoid any RT for the duration of the study.

First-Stage Interventions- Standard Protein Diet Counseling plus RT In order to control for the overall degree of dietary energy restriction, participants assigned to RT were prescribed a modified SOS diet that is lower in protein (20% of energy or ~0.9 g/kg body weight/d), proportionally higher in carbohydrate (53% of energy), and approximately equivalent in fat (26% of energy), but using the same overall food sources. Protein portions listed in the SOS Diet Rules were decreased to 2-3 ounces per meal and requiring non-vegetable carbohydrate foods at all 6 meals to achieve targeted differences in macronutrient composition between the diet plans. Prior to initiating the SOS program, participants assigned to RT were given resistance bands (either Premium Versa Tube, Power Systems, Knoxville TN, 37909, USA or Black Mountain Resistance Bands Set, Black Mountain Products, Inc. Spring Grove, IL 60081, USA) to use for the duration of the study. They also completed a virtual RT orientation session with a personal trainer via zoom to demonstrate proper technique for exercises and discuss the plan for RT progression (e.g., increase number of sets). They were instructed to engage in self-directed RT using the provided resistance bands and work up to three sets of 8-12 repetitions of eight exercises (squat, heel raise, overhead press, chest press, row, arm curl, triceps push-down, and abdominal flexion). Participants were instructed to begin with one set of each exercise and to add additional sets once s/he was able to achieve 12 repetitions of all exercises.

Second-Stage Interventions- Intensify: Protein Supplementation Participants re-randomized to the HP + RT combination or the protein supplementation arm received a shaker cup at no cost for weeks 8-16. The supplement provided was Optimum Nutrition Gold Standard Whey Protein Isolate, available in multiple flavors from which participants could choose. Each serving contained 24 g of protein and 110 kcal when mixed with water. Participants were instructed to consume two servings daily through week 16.

Second-Stage Interventions- Intensity: Supervised RT Supervised RT was led by a personal trainer in a group setting on two days per week for weeks 9-16. The participants were instructed to continue completing one day of RT on their own. Exercises for the supervised RT were the same as those prescribed for the 1st stage RT intervention.

Second-Stage Interventions- Combine: HP+RT Participants randomized to combine the HP+RT group were instructed to follow the unmodified HP SOS diet plan and were given protein supplements and supervised RT as described above for weeks 9-16.

Conditions
Obesity
Being tested
High Protein Diet Counseling, Resistance Training Counseling, Intensify Initial Intervention, Combined Supplement and Supervised Resistance Training
Keywords
weight loss, dietary protein, exercise training, fat free mass
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Protein Diet CounselingBehavioural

    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%.

  • Resistance Training CounselingBehavioural

    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.

  • Intensify Initial InterventionBehavioural

    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.

  • Combined Supplement and Supervised Resistance TrainingBehavioural

    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.

Study groups in NCT04014296
Study groupRoleWhat they receive
High Protein Diet Counseling, Add Protein Supplement for Non-Responders (Intensify)ExperimentalEnrollment 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.
Receives: Behavioral: High Protein Diet Counseling; Behavioral: Intensify Initial Intervention
Resistance Training Counseling, Supervised Resistance Training for Non-Responders (Intensify)ExperimentalEnrollment 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.
Receives: Behavioral: Resistance Training Counseling; Behavioral: Intensify Initial Intervention
High Protein Diet Counseling, Combine Protein and Resistance Training for Non-RespondersExperimentalEnrollment 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.
Receives: Behavioral: High Protein Diet Counseling; Behavioral: Combined Supplement and Supervised Resistance Training
Resistance Training Counseling, Combine Protein and Resistance Training for Non-RespondersExperimentalEnrollment 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.
Receives: Behavioral: Resistance Training Counseling; Behavioral: Combined Supplement and Supervised Resistance Training
High Protein Diet Counseling, ResponderExperimentalEnrolled 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.
Receives: Behavioral: High Protein Diet Counseling
Resistance Training Counseling, ResponderExperimentalEnrolled 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.
Receives: Behavioral: Resistance Training Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Screening through randomization, up to 6 months.

  2. 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.

    Measured: Baseline through week 16.

  3. 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.

    Measured: Baseline through week 16.

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Week 8

  6. 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.

    Measured: Baseline

  7. 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.

    Measured: Week 8

Secondary outcomes (9)
  1. Body Weight: Least Squares Mean Change From Baseline to Week 16 (Stage 1 Main Effect: HP vs RT; All Participants)

    Model-based (least squares / marginal) mean net change from baseline to Week 16 (Week 16 - baseline) by Stage 1 intervention (HP vs RT). The Stage 1 main effect is estimated as a marginal (averaged) effect over Week 8 responder status at Week 8 and among non-responders, over Stage 2 intervention assignment.

    Measured: Baseline to Week 16

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

    Model-based (least squares / marginal) mean net change from baseline to Week 16 among non-responders, where change = (Week 16 - Baseline). The Stage 2 main effect compares Intensify vs Combine, averaged over Stage 1 assignment.

    Measured: Baseline to Week 16

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

    Model-based (least squares / marginal) mean net change from baseline to Week 16 for each embedded adaptive intervention (EAI), where change = (Week 16 - Baseline).

    Measured: Baseline to Week 16

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

    Model-based (least squares / marginal) mean net change from baseline to Week 16 (Week 16 - baseline) by Stage 1 intervention (HP vs RT). The Stage 1 main effect is estimated as a marginal (averaged) effect over Week 8 responder status at Week 8 and among non-responders, over Stage 2 intervention assignment.

    Measured: Baseline to week 16

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

    Model-based (least squares / marginal) mean change from baseline to Week 16 among non-responders, where change = (Week 16 - Baseline). The Stage 2 main effect compares Intensify vs Combine, averaged over Stage 1 assignment.

    Measured: Baseline to week 16

  6. Fat Mass: Least Squares Mean Net Change From Baseline to Week 16 (Embedded Adaptive Interventions)

    Model-based (least squares / marginal) mean net change from baseline to Week 16 for each embedded adaptive intervention (EAI), where change = (Week 16 - Baseline).

    Measured: Baseline to Week 16

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

    Model-based (least squares / marginal) mean net change from baseline to Week 16 (Week 16 - baseline) by Stage 1 intervention (HP vs RT). The Stage 1 main effect is estimated as a marginal (averaged) effect over Week 8 responder status at Week 8 and among non-responders, over Stage 2 intervention assignment.

    Measured: Baseline to Week 16

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

    Model-based (least squares / marginal) mean change from baseline to Week 16 among non-responders, where change = (Week 16 - Baseline). The Stage 2 main effect compares Intensify vs Combine, averaged over Stage 1 assignment.

    Measured: Baseline to Week 16

  9. Fat-Free Mass: Least Squares Mean Change From Baseline to Week 16 (Embedded Adaptive Interventions)

    Model-based (least squares / marginal) mean net change from baseline to Week 16 for each embedded adaptive intervention (EAI), where change = (Week 16 - Baseline).

    Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2019
  2. Study start12 Apr 2021
  3. Primary completion31 May 2024
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Model description
This is a pilot Sequential Multiple Assignment Randomized Trial
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04014296
Sponsor's protocol ID
IRB-300003818
Other IDs
K01DK124244
Acronym
PRESS ON
Status last verified
Aug 2026
First submitted
5 Jul 2019
Last updated
22 Sep 2026
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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