Empowered With Movement to Prevent Obesity and Weight Regain



Status:Recruiting
Conditions:Obesity Weight Loss, Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:65 - 85
Updated:7/18/2018
Start Date:November 2016
End Date:November 2020
Contact:Charlotte Crotts
Email:chcrotts@wakehealth.edu
Phone:3367138503

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This study will help determine the appropriate type, amount and intensity of physical
activity most beneficial for preventing weight regain after weight loss in older adults.

The investigators will use a 3-group design in 180 older (65-85 years), obese (BMI=30-45
kg/m2), sedentary men and women, all of whom will undergo a 9-month Weight Loss (WL)
intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month
self-managed follow-up phase with minimal contact, to test our overall hypothesis that
intervening on Sedentary Behavior (SitLess) will enhance long-term Weight Loss in this age
group. The diet element of the intervention is identical across groups, but groups differ by
activity intervention: 1) structured, moderate-intensity, aerobic exercise (EX) (WL+EX); 2)
intervening on SB throughout the day (WL+SitLess); or 3) (WL+EX+SitLess).

Inclusion Criteria:

- 65-85 years

- BMI=30-45 kg/m2

- Weight stable—no loss or gain (±5%) in past 6 mo

- Sedentary

- No contraindication for safe and optimal participation in exercise training

- Approved for participation by Medical Director

- Willing to provide informed consent

- Agree to all study procedures and assessments

- Able to provide own transportation to study visits and intervention

Exclusion Criteria:

- Dependent on cane or walker

- Reported unintentional or intentional weight loss or gain of >5% in past 6 mo
Participation in regular resistance training and/or > 20 mins/day of aerobic exercise
in past 6 months

- Cognitive impairment (MoCA score <22)

- Low bone density (T-score < -2.3 on hip or spine scan)

- Severe arthritis, or other musculoskeletal disorder

- Joint replacement or other orthopedic surgery in past 6 mos

- Joint replacement or other orthopedic surgery planned in next 2 years

- Uncontrolled resting hypertension (>160/90 mmHg);

- Current or recent past (within 1 year) severe symptomatic heart disease,
uncontrolled angina, stroke, chronic respiratory disease other than asthma or
COPD, any disease requiring oxygen use, neurological or hematological disease;
cancer requiring treatment in past year, except non-melanoma skin cancers

- Serious conduction disorder, new Q waves or ST-segment depression (>3 mm), or
uncontrolled arrhythmia

- Room air SpO2 (oxygen saturation) at rest or with exercise qualifying for
supplementary oxygen (SpO2≤88%)

- Abnormal kidney or liver function (2x upper limit of normal);

- eGFR <45 mL/min/1.73m2

- Anemia (Hb<13 g/dL in men/ <12 g/dL in women);

- Uncontrolled diabetes (fasting glucose >140 mg/dl);

- Deficient levels of vitamin D (25 hydroxyvitamin D level < 20 ng/mL) in those not
taking a vitamin D supplement;

- Smoker (No nicotine in past yr)

- No heavy alcohol use (>14 drinks/week)

- Unstable severe depression

- Regular use of: growth hormones, oral steroids, weight loss medications or
prescription osteoporosis meds

- Current participation in other research study
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Principal Investigator: Barbara Nicklas, PhD
Phone: 336-713-8503
?
mi
from
Winston-Salem, NC
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