Clinical trial NCT04014296: Weight Loss in Adults Over 50 with Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight loss
dietary protein
exercise training
fat free mass
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 89
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment and Retention Rates
timeFrame: Baseline through week 52.
measure: Class Attendance
timeFrame: Baseline through week 52.
measure: 1st Stage Treatment Credibility
timeFrame: Baseline.
measure: 2nd Stage Treatment Credibility
timeFrame: Week 8.
measure: 1st Stage Intervention Preference
timeFrame: Baseline
measure: 2nd Stage Intervention Preference
timeFrame: Week 8
Secondary outcomes:
measure: Body Weight
timeFrame: Baseline, Weeks 8, 16, and 52
measure: Fat mass
timeFrame: Baseline, Weeks 8, 16, and 52
measure: Fat free mass
timeFrame: Baseline, Weeks 8, 16, and 52
Other outcomes:
measure: Change in glucose
timeFrame: Baseline to Weeks 8, 16, and 52
measure: Change in insulin
timeFrame: Baseline to Weeks 8, 16, and 52
measure: Changes in lipids
timeFrame: Baseline to Weeks 8, 16, and 52
measure: Changes in disposition index
timeFrame: Baseline to Weeks 8, 16, and 52
measure: Changes in aerobic fitness
timeFrame: Baseline to Weeks 8, 16, and 52
measure: Changes in physical activity
timeFrame: Baseline to Weeks 8, 16, and 52
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Drew Sayer, PhD
role: PRINCIPAL_INVESTIGATOR
References: