Empowered With Movement to Prevent Obesity and Weight Regain

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Empowered With Movement to Prevent Obesity and Weight Regain

Conditions
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Obesity, Weight Loss, Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Weight loss
* Behavioral: Exercise
* Behavioral: Sitless


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Weight loss + sitless<br>All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a  10% loss of initial body mass. Participants will be encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). | Behavioral: Weight loss<br>* All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a  10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.<br>* Other names: WL;Behavioral: Sitless<br>* Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).<br>* Other names: SL;|
| Other: Weight loss + exercise<br>All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a  10% loss of initial body mass. Participants will be asked to perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. | Behavioral: Weight loss<br>* All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a  10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.<br>* Other names: WL;Behavioral: Exercise<br>* Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.<br>* Other names: EX;|
| Other: Weight loss + exercise + sitless<br>All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a  10% loss of initial body mass. Participants will be encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). Participants will be asked to perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. | Behavioral: Weight loss<br>* All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a  10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.<br>* Other names: WL;Behavioral: Exercise<br>* Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.<br>* Other names: EX;Behavioral: Sitless<br>* Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).<br>* Other names: SL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Measured in clinic on the same scale | Baseline | 
| Body Weight | Measured in clinic on the same scale | 6 months | 
| Body Weight | Measured in clinic on the same scale | 18 months |