Impact of Weight Loss on Physical Function

NCT02079051 | Completed DMC

• 1 other identifier: IRB00025897
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

We are proposing a trial to directly compare a high intensity weight loss protocol to a moderate intensity weight loss protocol to determine which leads to greater improvements in physical function in severely obese older adults.

Conditions

Obesity

Keywords

Obesity Physical Performance Weight loss Optifast

Outcome Measures

Primary Outcomes (1)

• Change in Short Physical Performance Battery (SPPB)

  It is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task. The summary score ranges from 0 (worst) to 12 (best). The SPPB is a well-studied composite measure and a strong predictor of disability, institutionalization, morbidity and mortality in initially non-disabled older persons. The reliability of the individual components, as well as the summary score, are good, with intra-class correlation coefficients above 0.88, and the measure is sensitive to change. Even small changes of 0.5-0.6 points have been shown to be clinically meaningful. Importantly, it has recently been advocated as an important primary outcome to be used in RCTs designed to develop evidenced-based interventions to prevent or postpone functional decline.

  6 months

Study Arms (2)

High Intensity Weight Loss

EXPERIMENTAL

High intensity medical weight loss

Behavioral: High intensity medical weight loss

Moderate Intensity Weight Loss

ACTIVE COMPARATOR

Moderate intensity weight loss

Behavioral: Moderate intensity weight loss

Interventions

Moderate intensity weight loss BEHAVIORAL

A calorie restricted diet based on estimates of total energy expenditure (TEE) obtained from the measured resting metabolic rate (RMR) during a wt stable period. TEE will be estimated by multiplying RMR by a factor of 1.1-1.3 to cover activity energy expenditure based on an assessment of physical activity levels at baseline using accelerometry. We will use the TEE to create an individualized dietary rx for each pt, subtracting up to 500 calories from the estimated TEE. To ensure micronutrient needs are being met, total calories will not be decreased below 1200 kcal per day, regardless of the estimated TEE. They will receive a standard exercise program that will be designed to promote exercise energy expenditure of approximately 1200 kcal/week. We will prescribe resistance training for 2 days per week with a loading intensity of 60% of 1 rep max and volume of 3 sets at 8 reps per exercise. Aerobic training will be prescribed for 3 days per week.

Moderate Intensity Weight Loss

High intensity medical weight loss BEHAVIORAL

Placed on complete meal replacement (MR) using the OPTIFAST medical wt loss protocol. Pts will consume a min of 86 g of protein daily in 5-6 servings of MR. Min caloric intake will be 960 kcal/day with adjustments in intake made based on BMI and activity levels, holding the percent of calories from protein constant at 35%. The MRs provide 100% of daily recommended needs for micronutrients and will be supplied weekly at clinic visits by the study. Pts will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-26, caloric prescriptions will be between 1100 to 1600 kcal/day, using a combo of MRs and food. Will receive an exercise program designed to promote exercise energy expenditure of approximately 1200 kcal/week. We will prescribe resistance training for 2 days per week with a loading intensity of 60% of 1 rep max and volume of 3 sets at 8 reps per exercise. Aerobic training will be prescribed for 3 days per wk.

High Intensity Weight Loss

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• At least 65 years old at the time of the initial screening visit
• BMI greater than or equal to 35 kg/m2

You may not qualify if:

• Cognitive impairment (Montreal Cognitive Assessment \< 20)
• Depression (Centers for Epidemiologic Studies Depression Scale score \>16
• Recent weight change (+/- 10 lbs. in the last 12 months)
• History of non-skin cancer in the last 2 years
• Cardiovascular disease event or unstable angina within the past six months, severe pulmonary disease, renal failure
• Major liver dysfunction within the last 2 years
• Recently quit smoking less than 12 months prior
• Use of estrogen or testosterone replacement therapy
• Current use of medications for psychosis or manic-depressive illness
• Use of weight-loss medications in previous 3 months
• Dependence on others for food procurement or preparation
• Poorly controlled diabetes (HgA1c greater than or equal to 9%) or blood pressure (greater than or equal to 159 mm Hg systolic or 99 mm Hg diastolic)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Société des Produits Nestlé (SPN): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jamy Ard, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 5, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

US (1)