Clinical trial NCT02923674: Empowered With Movement to Prevent Obesity and Weight Regain
Official title: Empowered With Movement to Prevent Obesity and Weight Regain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Sedentary Lifestyle
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Wake Forest University
name: National Institute on Aging (NIA)
First posted: 2016-10-04
Enrollment: 183
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility 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

Primary outcomes:
measure: Body Weight
timeFrame: Baseline
measure: Body Weight
timeFrame: 6 months
measure: Body Weight
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
measure: Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
timeFrame: Baseline (0mo), 6mo, 18mo
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 8a
timeFrame: Baseline, 6mo, 18mo
measure: Pittsburg Fatigability Questionnaire
timeFrame: Baseline, 6mo, 18mo
measure: Short Form 36 Item (SF-36) Health Survey
timeFrame: Baseline, 6mo, 18mo
measure: Self-Efficacy for Walking Scale
timeFrame: Baseline, 6mo, 18mo
measure: Satisfaction With Physical Function Questionnaire
timeFrame: Baseline, 6mo, 18mo
measure: Self-Efficacy for Managing Eating Questionnaire
timeFrame: Baseline, 6mo, 18mo
measure: Experiences in Close Relationships Questionnaire
timeFrame: Baseline, 6mo, 18mo
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Baseline, 6mo, 18mo
measure: Power of Food Questionnaire
timeFrame: Baseline, 6mo, 18mo
measure: Perceived Stress Scale
timeFrame: Baseline, 6mo, 18mo
measure: Food Cravings Questionnaire
timeFrame: Baseline, 6mo, 18mo
measure: Technology Survey
timeFrame: 6mo, 18mo
measure: Intervention Survey
timeFrame: 6 mo, 18 mo
measure: Anthropometric Measures
timeFrame: Baseline, 6mo, 18mo
measure: Expanded Short Physical Performance Battery (eSPPB)
timeFrame: Baseline, 6mo, 18mo
measure: Treadmill Fatigability
timeFrame: Baseline, 6mo, 18mo
measure: Peak Aerobic Capacity (VO2) Peak
timeFrame: Baseline, 6mo, 18mo
measure: Grip Strength
timeFrame: Baseline, 6mo, 18mo
measure: Resting Metabolic Rate (RMR)
timeFrame: Baseline, 6mo, 18mo
measure: Activity Monitor
timeFrame: Baseline, 6mo, 18mo
measure: Ecological Momentary Assessment (EMA)
timeFrame: Baseline, 6mo
measure: 400 Meter Walk Test
timeFrame: Baseline, 6mo, 18mo
measure: Walking Efficiency
timeFrame: Baseline, 6mo, 18mo
measure: Visceral Fat
timeFrame: Baseline, 6mo, 18mo
measure: Bone Mineral Density (BMD)
timeFrame: Baseline, 6mo, 18mo
measure: Cardiometabolic Risk Factors--Lab Work
timeFrame: Baseline, 6mo, 18mo
measure: Satisfaction With Physical Function
timeFrame: Baseline, 6mo, 18mo
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sticht Center on Aging
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Barbara Nicklas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University
name: W. Jack Rejeski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.