Health Outcomes After Participating in Exercise (HOPE)

Obesity Clinical Trial

— HOPE  

Official title:

Long-term Function and Health Effects of Intentional Weight Loss in Obese Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430115
• Other study ID #: IRB00043576
• Secondary ID: 1R01AG056418-01
• Status: Completed
• Start date: February 20, 2018
• Est. completion date: July 27, 2021

Study information

• Verified date: October 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aging is associated with significant declines in muscle mass, strength, and physical performance, all of which lead to disability, loss of independence, and adverse clinical outcomes. Obesity exacerbates these age-related declines in function and is associated with poorer clinical outcomes and quality of life. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. The overall goals of this study are to determine if the short-term functional benefits of intentional weight loss are sustained long-term, and to examine the long-term benefits and risks of weight loss.

Description:

Obesity exacerbates age-related declines in function and is associated with poorer clinical outcomes and quality of life. Although clinical trials conducted study teams show that diet-induced weight loss interventions in obese older adults, when combined with exercise, improve body composition and physical and metabolic function in the short-term, the overall safety and long-term benefits of intentional weight loss in older adults remain controversial. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. Because of these concerns, health care providers are reluctant to recommend weight loss in obese older adults. The goal is to determine whether weight loss-induced improvements in body composition and physical and metabolic function observed in short-term clinical trials persist over time is critical to inform geriatric obesity treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: July 27, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• All former participants from the five intervention trials who respond to our recruitment strategies will be scheduled for clinic/home visits or a phone interview.

Exclusion Criteria:

• None - all former participants from the five intervention trials are eligible

Related Conditions & MeSH terms

• Aging
• Obesity
• Weight Loss

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	400 meter walk time	Participants are instructed to complete the 400 m distance (on a flat indoor surface) as quickly as possible at a maintainable pace and the time to complete the walk is recorded in seconds.	Baseline
Secondary	Short Physical Performance Battery score	The Short Physical Performance Battery (SPPB) is a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. Each of the three performance measures is assigned a score ranging from 0 (inability to do the test) to 4 (the highest level of performance) and summed to create an SPPB summary score ranging from 0 (worst) to 12 (best).	Baseline
Secondary	Knee extension strength	Maximal isokinetic knee extension strength. Maximal isokinetic knee extension strength will be measured using an isokinetic dynamometer (Biodex) at 60°/sec with the participant sitting and the hips and knee flexed at 90°. The maximum knee extensor strength of the 4 repetitions from trial 2 for the dominant leg will be will be used in analyses unless unable to test the dominant leg (i.e., knee replacement) in which case the non-dominant leg will be used.	Baseline
Secondary	Total body lean mass	Whole body lean mass will be measured by dual-energy X-ray absorptiometry (DXA).	Baseline
Secondary	Appendicular lean mass	Appendicular lean mass will be measured by DXA.	Baseline
Secondary	Total body fat mass	Whole body fat mass will be measured by DXA.	Baseline
Secondary	Total hip BMD	Bone mineral density (BMD) of the total hip will be measured by DXA.	Baseline
Secondary	Femoral neck BMD	Bone mineral density (BMD) of the femoral neck will be measured by DXA.	Baseline
Secondary	Lumbar spine BMD	Bone mineral density (BMD) of the lumbar spine (L1-L4) will be measured by DXA.	Baseline
Secondary	Subcutaneous abdominal fat	Subcutaneous abdominal fat will be measured by computed tomography (CT).	Baseline
Secondary	Visceral abdominal fat	Visceral abdominal fat will be measured by CT.	Baseline
Secondary	Thigh inter-muscular adipose tissue	Thigh inter-muscular adipose tissue will be measured by CT.	Baseline
Secondary	Glucose	Assessed via a standard clinical assay after fasting for at least 8 hours.	Baseline
Secondary	Insulin	Assessed via a standard clinical assay after fasting for at least 8 hours.	Baseline
Secondary	Total cholesterol	Assessed via a standard clinical lipid panel after fasting for at least 8 hours	Baseline
Secondary	HDL cholesterol	Assessed via a standard clinical lipid panel after fasting for at least 8 hours	Baseline
Secondary	LDL cholesterol	Assessed via a standard clinical lipid panel after fasting for at least 8 hours	Baseline
Secondary	Triglycerides	Assessed via a standard clinical lipid panel after fasting for at least 8 hours	Baseline
Secondary	Systolic blood pressure	Blood pressure will be measured in the right arm using an automated sphygmomanometer with the participant in a seated position after having rested quietly for 10-15 minutes. Participants will sit with feet flat on the floor and legs uncrossed and will be asked not to talk during the rest period or during the measurement. Systolic blood pressure will be defined as the average of three repeated measures.	Baseline
Secondary	Diastolic blood pressure	Blood pressure will be measured in the right arm using an automated sphygmomanometer with the participant in a seated position after having rested quietly for 10-15 minutes. Participants will sit with feet flat on the floor and legs uncrossed and will be asked not to talk during the rest period or during the measurement. Diastolic blood pressure will be defined as the average of three repeated measures.	Baseline
Secondary	C-reactive protein	C-reactive protein (CRP) will be determined using an automated immunoanalyzer.	Baseline
Secondary	Interleukin-6	Interleukin-6 (IL-6) will be assayed with high-sensitivity Quantikine®.	Baseline
Secondary	Soluble tumor necrosis factor receptor 1	Soluble tumor necrosis factor receptor 1 (sTNFR1) will be assayed with high-sensitivity Quantikine®.	Baseline