Empowered With Movement to Prevent Obesity and Weight Regain
EMPOWER
4 other identifiers
interventional
183
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Dec 2016
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedStudy Start
First participant enrolled
December 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedResults Posted
Study results publicly available
March 23, 2022
CompletedMarch 23, 2022
February 1, 2022
3.8 years
October 3, 2016
December 9, 2021
February 24, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Other Outcomes (28)
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Baseline (0mo), 6mo, 18mo
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 8a
Baseline, 6mo, 18mo
Pittsburg Fatigability Questionnaire
Baseline, 6mo, 18mo
- +25 more other outcomes
Study Arms (3)
Weight loss + sitless
OTHERAll 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).
Weight loss + exercise
OTHERAll 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.
Weight loss + exercise + sitless
OTHERAll 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.
Interventions
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.
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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);
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- Wake Forest Universitycollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Wake Forest Baptist Health Sticht Center on Aging
Winston-Salem, North Carolina, 27157, United States
Related Publications (2)
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.
PMID: 33135364DERIVEDFanning 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.
PMID: 30026128DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Barbara Nicklas, MD
- Organization
- Wake Forest School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Nicklas, PhD
Wake Forest University Health Sciences
- PRINCIPAL INVESTIGATOR
W. Jack Rejeski, PhD
Wake Forest University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 4, 2016
Study Start
December 6, 2016
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
March 23, 2022
Results First Posted
March 23, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share