Empowered With Movement to Prevent Obesity and Weight Regain

Not Applicable

Completed

• Conditions: Sedentary Lifestyle; Obesity; Weight Loss
• Interventions: Behavioral: Weight loss; Behavioral: Sitless; Behavioral: Exercise

• Registration Number: NCT02923674
• Lead Sponsor: Wake Forest University Health Sciences

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).

Study Timeline

• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Study Start: 2016-12-06
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Results First Submitted: 2021-12-09
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Results First Posted: 2022-03-23
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight loss + exercise	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. 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.
Weight loss + sitless	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).
Weight loss + exercise	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.
Weight loss + exercise + sitless	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. 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.
Weight loss + exercise + sitless	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 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.
Weight loss + sitless	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. 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).
Weight loss + exercise + sitless	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.

Primary Outcome Measures

Name	Time	Method
Body Weight	18 months	Measured in clinic on the same scale

Trial Locations

Locations (1)

Wake Forest Baptist Health Sticht Center on Aging; 🇺🇸 Winston-Salem, North Carolina, United States