Empowered With Movement to Prevent Obesity and Weight Regain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-06

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Eating Mindfully to Prevent Weight Regain

NCT04847843

Weight Loss Weight Gain Eating Behavior +2 more

COMPLETED NA

Physical Activity Following Surgery Induced Weight Loss

NCT00692367

Obesity

COMPLETED NA

A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain

NCT01664715

Overweight Obesity Weight Loss

COMPLETED NA

Engaging Motivation for the Prevention of Weight Regain

NCT01169428

Obesity

COMPLETED PHASE2

Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men

NCT00146107

Obesity

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Weight Loss Sedentary Lifestyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type OTHER

Weight loss

Intervention Type BEHAVIORAL

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.

Sitless

Intervention Type BEHAVIORAL

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

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.

Group Type OTHER

Weight loss

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

Weight loss

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

WL EX SL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No