Weight Loss in Adults Over 50 with Obesity

October 17, 2024 updated by: Drew Sayer, University of Alabama at Birmingham

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Drew Sayer, PhD
  • Phone Number: 205-354-8950
  • Email: sayerd@uab.edu

Study Contact Backup

  • Name: Katie Ellison, MS, RD
  • Phone Number: 205-600-7505
  • Email: vidya25@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3360
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment and Retention Rates
Time Frame: Baseline through week 52.
Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.
Baseline through week 52.
Class Attendance
Time Frame: Baseline through week 52.
Class Attendance will be tracked to determine clinical trial feasibility.
Baseline through week 52.
1st Stage Treatment Credibility
Time Frame: Baseline.
Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.
Baseline.
2nd Stage Treatment Credibility
Time Frame: 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.
Week 8.
1st Stage Intervention Preference
Time Frame: 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.
Baseline
2nd Stage Intervention Preference
Time Frame: 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.
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Baseline, Weeks 8, 16, and 52
Changes from baseline body weight will be measured at weeks 8, 16, and 52.
Baseline, Weeks 8, 16, and 52
Fat mass
Time Frame: Baseline, Weeks 8, 16, and 52
Changes from baseline fat mass will be measured at weeks 8, 16, and 52.
Baseline, Weeks 8, 16, and 52
Fat free mass
Time Frame: Baseline, Weeks 8, 16, and 52
Changes from baseline fat free mass will be measured at weeks 8, 16, and 52.
Baseline, Weeks 8, 16, and 52

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in glucose
Time Frame: Baseline to Weeks 8, 16, and 52
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
Time Frame: 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]
Baseline to Weeks 8, 16, and 52
Changes in lipids
Time Frame: Baseline to Weeks 8, 16, and 52
Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Baseline to Weeks 8, 16, and 52
Changes in disposition index
Time Frame: Baseline to Weeks 8, 16, and 52
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
Time Frame: Baseline to Weeks 8, 16, and 52
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
Time Frame: Baseline to Weeks 8, 16, and 52
7-day accelerometry
Baseline to Weeks 8, 16, and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Drew Sayer, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300003818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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