Arthritis Pilot for Preserving Muscle While Losing Weight

NCT ID: NCT02239939

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of this research study is to see whether wearing a weighted vest during a period of active weight loss can decrease the loss of muscle and bone that occurs during weight loss. We will also determine if study participants who wear the weighted vest will have greater improvements in physical function and self-reported disability, pain, stiffness, fatigue and quality of life. This knowledge could impact weight loss programs designed for older adults.

Hypothesis: Participants randomized to VEST will experience similar weight loss, but less loss of lean mass and bone density, than participants randomized to Control.

Detailed Description

The loss of muscle mass and bone density during weight loss is partially attributed to the decrease in mechanical stress on these tissues as weight is reduced. As a result, performing exercises that enhance muscle and gravitational loading during the period of caloric restriction usually diminishes the relative amount of muscle and bone loss for a given weight loss, but these interventions do not fully prevent all muscle and bone loss.In addition, conventional exercise training interventions often require expensive equipment, on-site participation, and, ideally for older, obese adults, safety supervision by trained exercise leaders. Moreover, the exercises performed may not fully translate into improvement in daily tasks due to training specificity, and are not always tolerated or sustained, especially in obese persons with OA. On the other hand, it is conceivable that treating the decrease in mechanical load from weight loss by externally replacing lost weight via use of a weighted vest may also be effective for reducing muscle and bone loss during caloric restriction. In animal models, mechanisms regulating skeletal tissue structure and function respond in a similar fashion to increases in actual or externally-added body mass. Also, research shows that exercising while wearing weighted vests can improve bone density, muscle mass, and lower extremity strength in older adults. However, no prior studies have examined the effects of weighted vest use on muscle mass and bone density during a period of intentional weight loss.

The main objective of this pilot study is to assess feasibility (accrual, retention, compliance) of daily use of a weighted vest during a diet intervention, to estimate the variability of outcome measures, and to obtain preliminary estimates of treatment efficacy. A controlled, randomized design will be used so we can obtain a realistic estimate of accrual and an unbiased estimate of treatment efficacy.

A total of 36 older (age=65-79 yrs), obese (BMI=30-40 kg/m2), sedentary men and women with x-ray evidence of knee OA will undergo a 22 week weight loss intervention (targeting 10% weight loss) with randomization to one of two groups (n=18/grp): 1) No vest use (Control); or 2) Progressive weighted vest use during normal daily activities (VEST).

Conditions

Obesity; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vest + Diet

All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.

Group Type: EXPERIMENTAL

Vest

Intervention Type: BEHAVIORAL

light weight, adjustable, vest to be worn underneath clothes that weight can be added to

Diet

Intervention Type: BEHAVIORAL

Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.

No Vest + Diet

All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: BEHAVIORAL

Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.

Interventions

Vest

light weight, adjustable, vest to be worn underneath clothes that weight can be added to

Intervention Type: BEHAVIORAL

Diet

Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.

Intervention Type: BEHAVIORAL

Other Intervention Names

Hyperwear Vest Pro; Medifast 4&2&1

Eligibility Criteria

Inclusion Criteria

• BMI=30-40 kg/m2; Wt<135 kg,
• self- reported MD diagnosis of osteoarthritis
• No evidence of clinical depression or other contraindications for participation in voluntary weight loss,
• Sedentary lifestyle (<30 min, 3 d/wk of exercise),
• Able to provide own transportation to study visits and intervention,
• Not dependent on a cane or walker,
• Willing and able to consume meal replacement products,
• Not involved in other research study,
• Approved for participation by Medical Director,
• Willing to provide informed consent.

Exclusion Criteria

• Weight loss or gain (±5%) in past 6 mos,
• Excessive alcohol use (> 14 drinks/wk),
• Smoker (>1 cigarette/d or 4/wk within yr),
• Evidence of cognitive impairment (MoCA score <22) or difficulty with hearing or vision that would interfere with study participation, Insulin-dependent or uncontrolled diabetes (FBG >125 mg/dl) or Hypertriglyceridemia (TG>400 mg/dl),
• Osteoporosis (T-score< -2.5 on hip or spine); Hip fracture, joint replacement, or spinal surgery in past 6 mos, or hyperkyphosis,
• Uncontrolled hypertension (BP>160/90 mmHg) or abnormal kidney or liver tests per Medical Director discretion,
• Self- reported hepatitis B or C,
• Severe anemia (Hb<10 g/100 ml),
• Past or current uncontrolled endocrine/metabolic disease, neurological or hematological disease, fibromyalgia, chronic pulmonary disease, hyperparathyroidism, rheumatoid arthritis, unstable angina, MI, cardiac surgery within 3 months,
• Cancer requiring treatment in past year except non-melanoma skin cancers,
• Regular use of medications that may influence body weight, hormones, weight loss medications, bone remodeling medication, prior use of medications that affect bone, insulin-dependent,
• Unable to tolerate vest run-in.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medifast, Inc.

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara J. Nicklas, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Health Sticht Center on Aging

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00028928

Identifier Type: -

Identifier Source: org_study_id