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N/A N=183 Randomized Double-blind Prevention

Empowered With Movement to Prevent Obesity and Weight Regain

Obesity · Weight Loss · Sedentary Lifestyle

Enrolled (actual)
183
Serious AEs
10.4%
Results posted
Mar 2022
Primary outcome: Primary: Body Weight — 94.7; 91.6; 95.1 kg

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Weight loss (Behavioral); Exercise (Behavioral); Sitless (Behavioral)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Oct 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Body Weight
89.8; 87.2; 88.7
PRIMARY
Body Weight
89.8; 87.2; 88.7
PRIMARY
Body Weight
89.8; 87.2; 88.7

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.

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 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 140 mg/dl);
  • Deficient levels of vitamin D (25 hydroxyvitamin D level 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02923674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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