Arthritis Pilot for Preserving Muscle While Losing Weight

NCT02239939 | Completed Results

• 1 other identifier: IRB00028928
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Osteoarthritis

Keywords

older adults, body composition, weight loss, muscle mass

Outcome Measures

Primary Outcomes (1)

• Change in Lean Mass Measured by DXA

  Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).

  Baseline and 22 weeks

Secondary Outcomes (2)

• Change in Hip Bone Density

  Basleine and 22 weeks

• Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)

  baseline and 22 weeks

Other Outcomes (2)

• Change in Body Weight

  Baseline and 22 weeks

• Changes in Lower Extremity Physical Function

  Baseline and 22 weeks

Study Arms (2)

Vest + Diet

EXPERIMENTAL

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.

Behavioral: Vest; Behavioral: Diet

No Vest + Diet

ACTIVE COMPARATOR

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.

Behavioral: Diet

Interventions

Vest BEHAVIORAL

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

Also known as: Hyperwear Vest Pro

Vest + Diet

Diet 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.

Also known as: Medifast 4&2&1

No Vest + Diet; Vest + Diet

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Medifast, Inc.: collaborator

Study Sites (1)

Wake Forest Baptist Health Sticht Center on Aging

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity; Osteoarthritis; Weight Loss

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Barbara Nicklas
• Organization: WFSM

bnicklas@wakehealth.edu

3367138569

Study Officials

• Barbara J. Nicklas, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 15, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 9, 2018
• Results First Posted: January 29, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)