Weight Loss in Adults Over 50 With Obesity

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: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: High Protein Diet; Behavioral: Resistance Training

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Recruitment and Retention Rates	Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.	Baseline through week 52.
Class Attendance	Class Attendance will be tracked to determine clinical trial feasibility.	Baseline through week 52.
1st Stage Treatment Credibility	Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.	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.	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.	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.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Changes from baseline body weight will be measured at weeks 8, 16, and 52.	Baseline, Weeks 8, 16, and 52
Fat mass	Changes from baseline fat mass will be measured at weeks 8, 16, and 52.	Baseline, Weeks 8, 16, and 52
Fat free mass	Changes from baseline fat free mass will be measured at weeks 8, 16, and 52.	Baseline, Weeks 8, 16, and 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glucose	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	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	Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides	Baseline to Weeks 8, 16, and 52
Changes in disposition index	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	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	7-day accelerometry	Baseline to Weeks 8, 16, and 52

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Drew Sayer, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Estimated): October 7, 2024
• Study Completion (Estimated): October 7, 2024

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: weight loss; exercise training; fat free mass; dietary protein
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID 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