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Clinical Trials/NCT02923674
NCT02923674
Completed
Not Applicable

Empowered With Movement to Prevent Obesity and Weight Regain

Wake Forest University Health Sciences1 site in 1 country183 target enrollmentDecember 6, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Wake Forest University Health Sciences
Enrollment
183
Locations
1
Primary Endpoint
Body Weight
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 6, 2016
End Date
October 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Body Weight

Time Frame: 18 months

Measured in clinic on the same scale

Study Sites (1)

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