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ObesityEMPOWERNCT02923674

Empowered With Movement to Prevent Obesity and Weight Regain

A study testing Weight loss, Exercise and Sitless in people with Obesity and Weight Loss, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Obesity, Weight Loss, Sedentary Lifestyle
What is being tested?
Weight loss, Exercise and Sitless
Could I receive a placebo?
No, everyone receives an active treatment
How many people
183 participants
Where
1 siteUnited States
Study dates
6 Dec 2016to 1 Oct 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • Willing to provide informed consent
  • Agree to all study procedures and assessments
  • Able to provide own transportation to study visits and intervention

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest Baptist Health Sticht Center on Aging

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the 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).

Being tested
Weight loss, Exercise, Sitless
Medical subject headings
Obesity, Weight Loss, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight lossBehavioural

    Also called WL

    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.

  • ExerciseBehavioural

    Also called EX

    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.

  • SitlessBehavioural

    Also called SL

    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).

Study groups in NCT02923674
Study groupRoleWhat they receive
Weight loss + sitlessOtherAll 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).
Receives: Behavioral: Weight loss; Behavioral: Sitless
Weight loss + exerciseOtherAll 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.
Receives: Behavioral: Weight loss; Behavioral: Exercise
Weight loss + exercise + sitlessOtherAll 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.
Receives: Behavioral: Weight loss; Behavioral: Exercise; Behavioral: Sitless

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Weight

    Measured in clinic on the same scale

    Measured: Baseline

  2. Body Weight

    Measured in clinic on the same scale

    Measured: 6 months

  3. Body Weight

    Measured in clinic on the same scale

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2016 (estimated)
  2. Study start6 Dec 2016
  3. Primary completion1 Oct 2020
  4. Study completion1 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02923674
Sponsor's protocol ID
IRB00035300
Other IDs
R01AG051624, R01AG051624-02S1, R01AG051624-02S2
Acronym
EMPOWER
Status last verified
Feb 2022
First submitted
3 Oct 2016
Last updated
23 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garcia RE, Fanning J, Kang C, Rockette-Wagner B, Kline CE, Nicklas BJ, Glynn NW. Weight Loss and Physical Activity Reduces Perceived Physical Fatigability Among Older Adults With Obesity. Obesity (Silver Spring). 2026 Sep 9. doi: 10.1002/oby.70298. Online ahead of print.

    PubMed 42716533

  • Burdette JH, Laurienti PJ, Miron LL, Bahrami M, Simpson SL, Nicklas BJ, Fanning J, Rejeski WJ. Functional Brain Networks: Unique Patterns with Hedonic Appetite and Confidence to Resist Eating in Older Adults with Obesity. Obesity (Silver Spring). 2020 Dec;28(12):2379-2388. doi: 10.1002/oby.23004. Epub 2020 Nov 1.

    PubMed 33135364

  • Fanning J, Opina MT, Leng I, Lyles MF, Nicklas BJ, Rejeski WJ. Empowered with Movement to Prevent Obesity & Weight Regain (EMPOWER): Design and methods. Contemp Clin Trials. 2018 Sep;72:35-42. doi: 10.1016/j.cct.2018.07.010. Epub 2018 Jul 17.

    PubMed 30026128

Questions about this trial

What is this clinical trial studying?

A study testing Weight loss, Exercise and Sitless in people with Obesity and Weight Loss, 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 9 inclusion and 21 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 23 Mar 2022. 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?

Yes. Results are posted in the registry (first posted 23 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Body Weight (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02923674, which also lists 3 linked publications.

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 23 Mar 2022.

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