Weight Loss in Adults Over 50 with Obesity

The University of Alabama at Birmingham

Status: Completed

Conditions: Obesity

Treatments: Behavioral: High Protein Diet; Behavioral: Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04014296

IRB-300003818

Details and patient eligibility

About

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).

Enrollment: 89 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

High Protein Diet

Experimental group

Description:

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

Treatment:

Behavioral: High Protein Diet

Resistance Training

Experimental group

Description:

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

Treatment:

Behavioral: Resistance Training