Weight Loss in Adults Over 50 with Obesity

NCT04014296 | Completed

• 1 other identifier: IRB-300003818
• 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 (6)

• 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 Outcomes (3)

• Body Weight

  Baseline, Weeks 8, 16, and 52

• Fat mass

  Baseline, Weeks 8, 16, and 52

• Fat free mass

  Baseline, Weeks 8, 16, and 52

Other Outcomes (6)

• Change in glucose

  Baseline to Weeks 8, 16, and 52

• Change in insulin

  Baseline to Weeks 8, 16, and 52

• Changes in lipids

  Baseline to Weeks 8, 16, and 52

Study Arms (2)

High Protein Diet

EXPERIMENTAL

Enrollment in State of Slim (SOS) weight loss program with a high protein diet.

Behavioral: High Protein Diet

Resistance Training

EXPERIMENTAL

Enrollment in State of Slim (SOS) weight loss program with resistance training counseling sessions.

Behavioral: Resistance Training

Interventions

High Protein Diet BEHAVIORAL

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.

High Protein Diet

Resistance Training BEHAVIORAL

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.

Resistance Training

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

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3360, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Diet, High-Protein; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Drew Sayer, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

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

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: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)