Weight Loss in Adults Over 50 With Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04014296
• Other study ID #: IRB-300003818
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: October 7, 2024

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 89
• Est. completion date: October 7, 2024
• Est. primary completion date: October 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Changes in lipids	Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides	Baseline to Weeks 8, 16, and 52
Other	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
Other	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
Other	Changes in physical activity	7-day accelerometry	Baseline to Weeks 8, 16, and 52
Primary	Recruitment and Retention Rates	Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.	Baseline through week 52.
Primary	Class Attendance	Class Attendance will be tracked to determine clinical trial feasibility.	Baseline through week 52.
Primary	1st Stage Treatment Credibility	Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.	Baseline.
Primary	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.
Primary	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
Primary	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	Body Weight	Changes from baseline body weight will be measured at weeks 8, 16, and 52.	Baseline, Weeks 8, 16, and 52
Secondary	Fat mass	Changes from baseline fat mass will be measured at weeks 8, 16, and 52.	Baseline, Weeks 8, 16, and 52
Secondary	Fat free mass	Changes from baseline fat free mass will be measured at weeks 8, 16, and 52.	Baseline, Weeks 8, 16, and 52