Clinical trial NCT03430115: Health Outcomes After Participating in Exercise (HOPE)
Official title: Long-term Function and Health Effects of Intentional Weight Loss in Obese Elders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Obesity
Aging
Keywords: Obese
Exercise
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-02-12
Enrollment: 588
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 400 meter walk time
timeFrame: Baseline
Secondary outcomes:
measure: Short Physical Performance Battery score
timeFrame: Baseline
measure: Knee extension strength
timeFrame: Baseline
measure: Total body lean mass
timeFrame: Baseline
measure: Appendicular lean mass
timeFrame: Baseline
measure: Total body fat mass
timeFrame: Baseline
measure: Total hip BMD
timeFrame: Baseline
measure: Femoral neck BMD
timeFrame: Baseline
measure: Lumbar spine BMD
timeFrame: Baseline
measure: Subcutaneous abdominal fat
timeFrame: Baseline
measure: Visceral abdominal fat
timeFrame: Baseline
measure: Thigh inter-muscular adipose tissue
timeFrame: Baseline
measure: Glucose
timeFrame: Baseline
measure: Insulin
timeFrame: Baseline
measure: Total cholesterol
timeFrame: Baseline
measure: HDL cholesterol
timeFrame: Baseline
measure: LDL cholesterol
timeFrame: Baseline
measure: Triglycerides
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: Baseline
measure: Diastolic blood pressure
timeFrame: Baseline
measure: C-reactive protein
timeFrame: Baseline
measure: Interleukin-6
timeFrame: Baseline
measure: Soluble tumor necrosis factor receptor 1
timeFrame: Baseline
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Denise Houston, PhD
role: PRINCIPAL_INVESTIGATOR
References: