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Completed

NCT Number: NCT03430115

Health Outcomes After Participating in Exercise (HOPE)

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.

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Key information

Conditions

Weight Loss Aging Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 400 meter walk time

    Time frame: Baseline

    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.

Secondary outcomes

  1. Short Physical Performance Battery score

    Time frame: Baseline

    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).

  2. Knee extension strength

    Time frame: Baseline

    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.

  3. Total body lean mass

    Time frame: Baseline

    Whole body lean mass will be measured by dual-energy X-ray absorptiometry (DXA).

  4. Appendicular lean mass

    Time frame: Baseline

    Appendicular lean mass will be measured by DXA.

  5. Total body fat mass

    Time frame: Baseline

    Whole body fat mass will be measured by DXA.

  6. Total hip BMD

    Time frame: Baseline

    Bone mineral density (BMD) of the total hip will be measured by DXA.

  7. Femoral neck BMD

    Time frame: Baseline

    Bone mineral density (BMD) of the femoral neck will be measured by DXA.

  8. Lumbar spine BMD

    Time frame: Baseline

    Bone mineral density (BMD) of the lumbar spine (L1-L4) will be measured by DXA.

  9. Subcutaneous abdominal fat

    Time frame: Baseline

    Subcutaneous abdominal fat will be measured by computed tomography (CT).

  10. Visceral abdominal fat

    Time frame: Baseline

    Visceral abdominal fat will be measured by CT.

  11. Thigh inter-muscular adipose tissue

    Time frame: Baseline

    Thigh inter-muscular adipose tissue will be measured by CT.

  12. Glucose

    Time frame: Baseline

    Assessed via a standard clinical assay after fasting for at least 8 hours.

  13. Insulin

    Time frame: Baseline

    Assessed via a standard clinical assay after fasting for at least 8 hours.

  14. Total cholesterol

    Time frame: Baseline

    Assessed via a standard clinical lipid panel after fasting for at least 8 hours

  15. HDL cholesterol

    Time frame: Baseline

    Assessed via a standard clinical lipid panel after fasting for at least 8 hours

  16. LDL cholesterol

    Time frame: Baseline

    Assessed via a standard clinical lipid panel after fasting for at least 8 hours

  17. Triglycerides

    Time frame: Baseline

    Assessed via a standard clinical lipid panel after fasting for at least 8 hours

  18. Systolic blood pressure

    Time frame: Baseline

    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.

  19. Diastolic blood pressure

    Time frame: Baseline

    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.

  20. C-reactive protein

    Time frame: Baseline

    C-reactive protein (CRP) will be determined using an automated immunoanalyzer.

  21. Interleukin-6

    Time frame: Baseline

    Interleukin-6 (IL-6) will be assayed with high-sensitivity Quantikine®.

  22. Soluble tumor necrosis factor receptor 1

    Time frame: Baseline

    Soluble tumor necrosis factor receptor 1 (sTNFR1) will be assayed with high-sensitivity Quantikine®.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: HOPE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2018
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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