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Empowered With Movement to Prevent Obesity and Weight Regain (EMPOWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923674
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
Wake Forest University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Sedentary Lifestyle Behavioral: Weight loss Behavioral: Exercise Behavioral: Sitless Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Empowered With Movement to Prevent Obesity and Weight Regain
Study Start Date : November 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Weight loss + sitless

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
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.
Other Name: WL

Behavioral: Sitless
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).
Other Name: SL

Weight loss + exercise

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
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.
Other Name: WL

Behavioral: Exercise
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.
Other Name: EX

Weight loss + exercise + sitless

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
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.
Other Name: WL

Behavioral: Exercise
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.
Other Name: EX

Behavioral: Sitless
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).
Other Name: SL




Primary Outcome Measures :
  1. Change in Body weight [ Time Frame: Baseline, 6 months, 18 months ]
    Weight will be assessed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923674


Locations
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United States, North Carolina
Wake Forest Baptist Health Sticht Center on Aging
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Wake Forest University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Barbara Nicklas, PhD Wake Forest University Health Sciences
Principal Investigator: W. Jack Rejeski, PhD Wake Forest University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02923674    
Other Study ID Numbers: IRB00035300
R01AG051624 ( U.S. NIH Grant/Contract )
R01AG051624-02S1 ( U.S. NIH Grant/Contract )
R01AG051624-02S2 ( U.S. NIH Grant/Contract )
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Body Weight
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms
Body Weight Changes