Empowered With Movement to Prevent Obesity and Weight Regain

Obesity Clinical Trial

— EMPOWER  

Official title:

Empowered With Movement to Prevent Obesity and Weight Regain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923674
• Other study ID #: IRB00035300
• Secondary ID: R01AG051624R01AG
• Status: Completed
• Phase: N/A
• Start date: December 6, 2016
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Sedentary Lifestyle
• Weight Loss

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health Sticht Center on Aging	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA), Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale	13 item scale used to measure fatigue over the past week with a 4-point Likert scale. The score range is 0-52 with a score of less than 30 indicating severe fatigue, and higher score denoting a better quality of life.	Baseline (0mo), 6mo, 18mo
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 8a	DAn 8 item questionnaire that assess fatigue over the past 7 days. All items are summed with the lowest possible score equaling 8 and the highest, a 40. A higher score indicates more fatigue.	Baseline, 6mo, 18mo
Other	Pittsburg Fatigability Questionnaire	10 item scale that assesses fatigability (fatigue in the context of a standardized task). A higher score indicates a higher performance fatigability, slower gait speed, worsening physical function.; A 10 item scale that assesses fatigability (fatigue in the context of a standardized task). Score range is 0-50 with a higher score = a higher performance fatigability, slower gait speed, worsening physical function.	Baseline, 6mo, 18mo
Other	Short Form 36 Item (SF-36) Health Survey	A 36 item survey of overall health broken into 8 scaled scores of vitality, physical function, pain, general health, mental health, social, physical, and emotional role functioning. Ranging from 0 to 100, the lower a person scores, the more disability.	Baseline, 6mo, 18mo
Other	Self-Efficacy for Walking Scale	Self-reported measure used to determine a person's belief in their physical capability to successfully complete incremental walking distances (5-40 minutes) at a moderate pace. The total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.	Baseline, 6mo, 18mo
Other	Satisfaction With Physical Function Questionnaire	A scale testing how satisfied an individual is with their physical fitness and abilities. Levels of satisfaction are rated on a 7 point scale from very dissatisfied to very satisfied. All items are then averaged to create a score ranging from -3 to 3.	Baseline, 6mo, 18mo
Other	Self-Efficacy for Managing Eating Questionnaire	Used to measure self-efficacy for appropriate eating using 5 subscales (Negative Emotions, Availability, Social Pressure, Physical Discomfort, Positive Activities) of 4 items each (e.g., "I can resist eating even when high-calorie foods are available"). Item responses range from 0 (not confident) to 9 (very confident). An average score is created for each subscale and then a total score by averaging across all items. On a scale from 10 to 40, higher scores represent greater confidence in being able to restrain oneself from eating under difference contexts.	Baseline, 6mo, 18mo
Other	Experiences in Close Relationships Questionnaire	Scale used to evaluate the construct of adult attachment by examining avoidance and anxiety. A person rates each statement about connection using a 7-point Likert scale which ranges from 1 (strongly disagree) to 7 (strongly agree). To obtain score, average responses from all 36 items. A score will range from 7 to 42 with a higher score representing insecure attachment.	Baseline, 6mo, 18mo
Other	Mindful Attention Awareness Scale (MAAS)	15-item questionnaire used to assess the core characteristic of mindfulness, or an awareness of and attention to what is taking place in the present. The 15 items are collected in a Likert scale, totaled, and averaged for a final score ranging from 1-7. A higher score reflects higher levels of mindfulness and a lower score is indicative of a negative emotional state.	Baseline, 6mo, 18mo
Other	Power of Food Questionnaire	Scale assessing the psychological impact of living in food-abundant environments. It measures appetite for, rather than consumption of, palatable foods, at three levels of food proximity (food available, food present, and food tasted).	Baseline, 6mo, 18mo
Other	Perceived Stress Scale	A questionnaire used to measure the perception of stress and how often a person felt that way in the last month. Individual scores range from 0 to 40 with higher scores indicating a person perceives higher levels of stress which could lead to or correlate with negative behaviors such as stress eating or decreases in physical activity	Baseline, 6mo, 18mo
Other	Food Cravings Questionnaire	15-item measure of short-term changes in food cravings. Responses are made on a five-point Likert scale with response categories ranging from 1 (strongly disagree) to 5 (strongly agree). The scale yields a sum total from the five subscale scores, including, 1) an intense desire to eat; 2) anticipation of positive reinforcement that may result from eating; 3) anticipation of relief from negative states and feelings as a result of eating; 4) obsessive preoccupation with food or lack of control over eating; and 5) craving as a physiological state. Sum scores range from 15 to 90 with higher scores representing more frequent and intense experiences of craving food.	Baseline, 6mo, 18mo
Other	Technology Survey	Administered during assessment visits to gain insight on the participants' opinion of the technology (i.e., Empower application and web-based questionnaires, any tests/emails received from the Empower team) used in the study. Examples of these open-ended questions include: 1) How useful did you find the Empower smartphone app?; 2) To what extent was the Empower app a burden to use?; 3) How difficult or easy was the app to use?; 4) How important did you feel the app was to your experience in the Empower study?; 5) What were one or two of your favorite and least favorite features of the Empower app? Questions were not scored or used in data analysis, but provided staff with an overall user opinion as well as constructive criticism in order to improve similar technologies in future studies.	6mo, 18mo
Other	Intervention Survey	Administered at assessment visits to gain inside on the participants' opinion on the group dynamic used in the first 6 months of the study. Examples of the dichotomous questions include: 1) Did you enjoy working with the staff and participants?; 2) Did you feel pressured by staff and or participants to do well in the study?; 3) Did you get along with the staff and participants in Empower?; 4) Did you feel comfortable expressing your ideas and opinions to staff members and fellow participants?; 5) Do you feel people a part of the Empower study care about you? Questions were not scored or used in data analysis, but provided staff with an overall opinion of participant experience as well as constructive criticism in order to improve similar group settings in future studies.	6 mo, 18 mo
Other	Anthropometric Measures	Three anthropometric measures at three anatomical locations are taken using a handheld measuring table with tension and recorded in centimeters. The waist measurement is taken at the narrowest part of the torso below the ribcage and above the umbilicus. The hip measurement is measured at the maximal circumference of the buttocks. The mid-thigh is taken with the knee bent to 90°, midway between the inguinal crease and the proximal border of the patella. The measurements taken at each site are averaged. A waist/hip ratio is calculated.	Baseline, 6mo, 18mo
Other	Expanded Short Physical Performance Battery (eSPPB)	Consists of a test of balance, gait speed test, and chair stand, performed in this order. The following equipment is required for the expanded SPPB: digital stopwatch, masking tape, measuring tape, script, and a straight-backed armless chair with a hard seat. To eliminate the effect of different footwear on test performance, tests are performed in tennis shoes or comfortable walking shoes with minimal or no heels. Tests are individually scored 0-4 and then totaled for a maximal score of 12. The higher a score, the better an individual's mobility and functional ability.	Baseline, 6mo, 18mo
Other	Treadmill Fatigability	Test is done on a treadmill to assess perceived fatigability at a given workload. Participants are asked to rate their RPE (rating of perceived exertion) just as they start walking (0 min, 2.0 mph), half way through (2.5 min, 2.0 mph), and at the end of the test (5 min, 2.0 mph). Heart rate via a heart rate monitoring watch will be recorded at these same intervals.	Baseline, 6mo, 18mo
Other	Peak Aerobic Capacity (VO2) Peak	Measured during a maximal graded exercise test (GXT) to exhaustion on a treadmill using a Raise, Activate, Mobilise, Potentiate (RAMP) protocol. The GXT is used to rule out any latent coronary artery disease and to measure cardiovascular functional capacity and peak oxygen uptake. The respiratory rate, minute ventilation, breathing reserve, VO2, Validation of Carbon Dioxide Production (VCO2), respiratory exchange ratio, one metabolic equivalent (MET) level, heart rate (HR), VO2/HR, kilocalorie/minutes (Kcal/min), Rating of Perceived Exertion (RPE) and Blood pressure (BP) at test conclusion are recorded.	Baseline, 6mo, 18mo
Other	Grip Strength	The Jaymar Handheld Dynamometer is used to measure grip strength in both hands. To the nearest and highest kilogram achieved, hand grip strength is a commonly used measure of upper body skeletal muscle function and has been widely used as a general indicator of frailty with predictive validity for both mortality and functional limitation.	Baseline, 6mo, 18mo
Other	Resting Metabolic Rate (RMR)	A facemask will be placed on the participant while he/she is lying on the exam table. Measures of oxygen consumption and carbon dioxide production will be collected continuously for 30 minutes and the RMR will be calculated using the Weir equation.	Baseline, 6mo, 18mo
Other	Activity Monitor	Used to evaluate time spent in sedentary behavior, light, and moderate to vigorous physical activity (MVPA). An activPAL™ accelerometer (PAL Technologies, Glasgow, Scotland) is worn for 7-days at each of the three assessment visits: baseline, 6-months and 18-months. The monitor uses accelerometer-derived information about thigh position to estimate time spent in different body positions: lying or sitting = sedentary; standing still; and stepping = light and MVPA. Data is downloaded at the end of each 7-day period and cleaned and summarized for statistical analyses. The proprietary algorithm in the activPAL software is used to generate estimates of (a) Total Daily Energy Expenditure (TDEE); (b) sedentary time during the day, (c) number of breaks in sedentary time, (d) minutes spent in light activity, and (e) number of minutes spent in MVPA.	Baseline, 6mo, 18mo
Other	Ecological Momentary Assessment (EMA)	Used to determine the relationship between dynamic food variables, physical activity variables, and long-term weight loss. Prior to the start of the intervention and following the initial intervention period, participants complete week-long daily assessments. The following are the different scales and questions asked of participants: 1) Affective Valence from the Feelings Scale (scored 0 - 10 where 0 = very bad and 10 = very good). 2) Six items from the exercise-induced feelings inventory, each on a 0 ="do not feel" to 10="feel very strongly" score. Calm, peaceful, and relaxed are then averaged for a "tranquility" subscale; "fatigued, "tired" and "worn-out" are averaged for a physical exhaustion subscale. 3) Hunger was queried by "How hungry are you right now?" where 0 = not at all hungry, and 10 = very hungry. 4) An individual's craving for food was queried by "How much do you crave eating your favorite food or snack right now?" where 0 = "do not feel" and 10 = "feel very strongly".	Baseline, 6mo
Other	400 Meter Walk Test	Test is completed at a quick pace (without running) that the participant can maintain over the flat, 400 meter course. Timing begins when the participant takes his/her first step. Timing ends when the participant's whole foot crosses the line at the end of the 10th lap or the participant requests to stop. Recorded is the distance completed and time walked in minutes and seconds.	Baseline, 6mo, 18mo
Other	Walking Efficiency	Used to determine the number of calories burned while walking at 2.0 mph on a treadmill with zero grade. Heart rate (HR) is measured continuously using a heart rate monitoring watch and will be recorded every minute. Blood pressure (BP) is monitored and recorded every minute. The test is terminated when the (HR) remains at a steady state (is within 5 beats per minute of the HR from the previous minute). The time to achieve steady state heart rate, the respiratory rate, minute ventilation, breathing reserve, VO2, VCO2, respiratory exchange ratio, MET level, HR, VO2/HR, Kcal/min, and the BP at steady state are recorded.	Baseline, 6mo, 18mo
Other	Visceral Fat	A visceral fat measurement is obtained through a dual-energy X-ray absorptiometry (DEXA) whole body scan in a 5-cm wide region across the entire abdomen just above the iliac crest at a level approximate with the 4th lumbar vertebrae. Mass visceral fat is measured to the nearest gram and volume to the nearest centimeter.	Baseline, 6mo, 18mo
Other	Bone Mineral Density (BMD)	Hip and spine BMD is measured using specific scans of the anterior-posterior spine Lumbar vertebrae 1-Lumbar vertebrae 4 (L1-L4) and proximal femur by dual-energy X-ray absorptiometry. BMD is recorded as a t-score with a lower score indicative of less bone density and increased risk for osteoporosis.	Baseline, 6mo, 18mo
Other	Cardiometabolic Risk Factors--Lab Work	An 8-hour fasting venous blood sample is collected to measure cardiometabolic changes lipoprotein lipids, C-reactive protein, HbA1c, glucose and insulin.	Baseline, 6mo, 18mo
Other	Satisfaction With Physical Function	Scale used to test how satisfied participants are with their physical fitness, functional ability, and physical appearance. Participants rate their level of satisfaction on a 7-point scale from very dissatisfied to very satisfied. Average all items to create a score ranging from -3 to 3. Higher values represent greater satisfaction with physical function and importance.	Baseline, 6mo, 18mo
Primary	Body Weight	Measured in clinic on the same scale	Baseline
Primary	Body Weight	Measured in clinic on the same scale	6 months
Primary	Body Weight	Measured in clinic on the same scale	18 months