Weight LossHOPENCT03430115
Health Outcomes After Participating in Exercise (HOPE)
An observational study of Weight Loss and Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity, Aging
- How many people
- 588 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 27 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants aged 60 and older at randomization who were randomized to a weight loss intervention that was combined with an exercise intervention (WL+EX, n=392), to an exercise intervention alone (EX alone, n=340), to a weight loss intervention alone (n=128), or to a control group (n=106) from five weight loss and exercise randomized controlled trials.
Who may be able to join
- 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.
Who cannot join
- None - all former participants from the five intervention trials are eligible
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Long-term Function and Health Effects of Intentional Weight Loss in Obese Elders
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.
Read the detailed 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.
- Conditions
- Weight Loss, Obesity, Aging
- Keywords
- Obese, Exercise
- Medical subject headings
- Weight Loss, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss plus exercise (WL+EX) | This group was randomized and previously assigned to weight loss plus exercise. | |
| Exercise alone (EX) | This group was randomized and previously assigned to exercise alone. | |
| Weight loss alone (WL) | This group was randomized and previously assigned to weight loss alone. | |
| Control | This group was randomized and previously assigned to control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (22)
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).
Measured: Baseline
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.
Measured: Baseline
Total body lean mass
Whole body lean mass will be measured by dual-energy X-ray absorptiometry (DXA).
Measured: Baseline
Appendicular lean mass
Appendicular lean mass will be measured by DXA.
Measured: Baseline
Total body fat mass
Whole body fat mass will be measured by DXA.
Measured: Baseline
Total hip BMD
Bone mineral density (BMD) of the total hip will be measured by DXA.
Measured: Baseline
Femoral neck BMD
Bone mineral density (BMD) of the femoral neck will be measured by DXA.
Measured: Baseline
Lumbar spine BMD
Bone mineral density (BMD) of the lumbar spine (L1-L4) will be measured by DXA.
Measured: Baseline
Subcutaneous abdominal fat
Subcutaneous abdominal fat will be measured by computed tomography (CT).
Measured: Baseline
Visceral abdominal fat
Visceral abdominal fat will be measured by CT.
Measured: Baseline
Thigh inter-muscular adipose tissue
Thigh inter-muscular adipose tissue will be measured by CT.
Measured: Baseline
Glucose
Assessed via a standard clinical assay after fasting for at least 8 hours.
Measured: Baseline
Insulin
Assessed via a standard clinical assay after fasting for at least 8 hours.
Measured: Baseline
Total cholesterol
Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Measured: Baseline
HDL cholesterol
Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Measured: Baseline
LDL cholesterol
Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Measured: Baseline
Triglycerides
Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
C-reactive protein
C-reactive protein (CRP) will be determined using an automated immunoanalyzer.
Measured: Baseline
Interleukin-6
Interleukin-6 (IL-6) will be assayed with high-sensitivity Quantikine®.
Measured: Baseline
Soluble tumor necrosis factor receptor 1
Soluble tumor necrosis factor receptor 1 (sTNFR1) will be assayed with high-sensitivity Quantikine®.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start20 Feb 2018
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Denise Houston, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430115
- Sponsor's protocol ID
- IRB00043576
- Other IDs
- 1R01AG056418-01
- Acronym
- HOPE
- Status last verified
- Oct 2021
- First submitted
- 4 Feb 2018
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Function and Health Effects of Intentional Weight Loss in Obese Elders
- ClinicalTrials.gov ID
- NCT03430115
- Acronym / sponsor ID
- HOPE / IRB00043576
- Conditions
- Weight Loss, Obesity, Aging
- Keywords
- Obese, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Weight loss plus exercise (WL+EX) | – | –This group was randomized and previously assigned to weight loss plus exercise. |
| Exercise alone (EX) | – | –This group was randomized and previously assigned to exercise alone. |
| Weight loss alone (WL) | – | –This group was randomized and previously assigned to weight loss alone. |
| Control | – | –This group was randomized and previously assigned to control. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All participants aged 60 and older at randomization who were randomized to a weight loss intervention that was combined with an exercise intervention (WL+EX, n=392), to an exercise intervention alone (EX alone, n=340), to a weight loss intervention alone (n=128), or to a control group (n=106) from five weight loss and exercise randomized controlled trials.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None - all former participants from the five intervention trials are eligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
22 secondary outcomes
Short Physical Performance Battery score
Time frame: Baseline
Knee extension strength
Time frame: Baseline
Total body lean mass
Time frame: Baseline
Appendicular lean mass
Time frame: Baseline
Total body fat mass
Time frame: Baseline
Total hip BMD
Time frame: Baseline
Femoral neck BMD
Time frame: Baseline
Lumbar spine BMD
Time frame: Baseline
Subcutaneous abdominal fat
Time frame: Baseline
Visceral abdominal fat
Time frame: Baseline
Thigh inter-muscular adipose tissue
Time frame: Baseline
Glucose
Time frame: Baseline
Insulin
Time frame: Baseline
Total cholesterol
Time frame: Baseline
HDL cholesterol
Time frame: Baseline
LDL cholesterol
Time frame: Baseline
Triglycerides
Time frame: Baseline
Systolic blood pressure
Time frame: Baseline
Diastolic blood pressure
Time frame: Baseline
C-reactive protein
Time frame: Baseline
Interleukin-6
Time frame: Baseline
Soluble tumor necrosis factor receptor 1
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
Related trials for Weight Loss
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Houston, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
400 meter walk time (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.