Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami
ClinicalTrials.gov Identifier:
NCT01467817
First received: September 26, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine how exercise and nutritional guidance and supplementation affects your physical fitness, risk for heart disease, your body's ability to burn fat, and your opinions about your health.


Condition Intervention Phase
Overweight
Obese
Spinal Cord Injury
Behavioral: Lifestyle Intervention
Behavioral: Exercise Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Obesity/Overweight in Persons With Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Body mass [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Study specific aims and their accompanying hypotheses will test effect of intervention on:1)reducing body weight and radiographically-derived body fat, 2)improving fitness as assessed by endurance, strength, and anaerobic power,3) reducing risks of fasting dyslipidemia, post-prandial lipemia, and insulin resistance, and 4) enhancing perceived health-related quality of life. the primary trial goal pays fidelity to the DPP by targeting sustained loss of 7% of body weight, a proven countermeasure for prevention of diabetes.


Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Intervention
This arm will test the combination of 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support.
Behavioral: Lifestyle Intervention
The intervention incorporates 6 months of active structured lifestyle intervention containing participant education, exercise, dietary intervention, and behavioral support
Placebo Comparator: Exercise Control
This arm will test the benefits of exercise alone while controlling for investigator contact.
Behavioral: Exercise Control
The control group intervention will test benefits of exercise alone while controlling for investigator contact.

Detailed Description:

The study plan will enroll 80 persons with Spinal Cord Injury (SCI) who are overweight/obese and have fasting atherogenic dyslipidemia and dysglycemia. A Data Safety Management Board will oversee the trial. Interventions will include 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support A second arm will test benefits of exercise alone while controlling for investigator contact. Multiple baselines tested before intervention will serve as a treatment control.

Exercise will include a six-month circuit resistance training program already established as effective in fitness attainment for persons with paraplegia and tetraplegia. Dietary intervention over the same period will balance caloric expenditure measured by indirect calorimetry and food intake, the latter coming from a Mediterranean style diet having effectiveness established in the DPP for durable weight loss and diabetes prevention. The investigators and personal 'lifestyle coaches' will then shape and follow client-specific exercise and diet programs to be conducted for 12 months in the home or community-based centers. Behavioral approaches will include a 16-week training curriculum presented in both small groups and with the lifestyle coaches. Other behavioral approaches will include customized trial information booklets, performance incentives, outcome challenges between centers, and use of the VA Telehealth system for performance tracking, compliance assessment, and motivational support.

Study specific aims and their accompanying hypotheses will test effects of intervention on: 1) reducing body weight and radiographically-derived body fat, 2) improving fitness as assessed by endurance, strength, and anaerobic power, 3) reducing risks of fasting dyslipidemia, post-prandial lipemia, and insulin resistance, and 4) enhancing perceived health-related quality of life. Data will be analyzed by Multivariate analysis with repeated measures. Ancillary testing will investigate effects of intervention on the whole body oxidation of fat at rest and following food intake, and examine the relationship between dietary intake and caloric expenditure at the beginning and the end of the 18 month study. The primary trial goal pays fidelity to the DPP by targeting sustained loss of 7% of body weight, a proven countermeasure for prevention of diabetes. Positive results of training will represent the first evidence-based randomized multi-center trial of sustained weight loss in persons with SCI - military or civilian. In the near term the data will provide evidence needed to initiate health reform of military and non-military constituencies with disability. The information will also underwrite changes in dietary support of newly injured persons. The information will further provide a roadmap for clinicians to institute client-centered programs of health planning and recovery. As the extension phase will test both home and community-based programs, deployment to wider military constituencies of persons with SCI can be achieved through VA Community Outpatient Clinics. The trial can also become a roadmap to weight and disease management experience by persons with physical impairments other than SCI.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participants will include 64 men and women aged 18-65 years with SCI (AIS A-C) at the C5-L1 levels for more than 1 year.
  • the International Standards for Neurological Classification of SCI (ASIA/ISCoS) will serve as benchmarks for subject classification. A physician-rater experienced in these procedures will classify subjects upon study entry.

Exclusion Criteria:

Study candidates will be excluded from study because of:

  • structured exercise conditioning for recreation or competition within 6 months of study entry;
  • defined diet involving caloric restriction or nutrient modification;
  • weight loss or gain of 5% within the preceding 6 months;
  • surgery within 6 months;
  • pressure ulcer within 3 months;
  • upper limb pain that limits exercise;
  • recurrent acute infection or illness requiring hospitalization or IV antibiotics;
  • pregnancy;
  • previous MI or cardiac surgery;
  • 6 month history of glucose-lowering and lipid-lowering drug therapy;
  • Type I or II diabetes (by WHO criteria); and
  • daily intake of vitamin supplements exceeding 100% RDA.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467817

Contacts
Contact: Kimberly Anderson, PhD 305-243-7108 mpinfo@med.miami.edu

Locations
United States, Florida
University Of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Kimberly Anderson, Ph.D.    305-243-7108    kanderson3@med.miami.edu   
Contact: Mark S Nash, Ph.D.    305-243-3628    mnash@med.miami.edu   
Principal Investigator: Mark S Nash, Ph.D.         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Mark S Nash, PhD University of Miami
  More Information

Additional Information:
No publications provided

Responsible Party: Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01467817     History of Changes
Other Study ID Numbers: TMP-MN-009
Study First Received: September 26, 2011
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
body mass
abdominal fat
whole body lean mass
insulin resistance
caloric intake
expenditure
endurance
Strength
TC:HDL ratio
LDL:HDL ratio
area under the TG response curve
feeding challenge
fasting and post-prandial whole body fat oxidation
HRQoL

Additional relevant MeSH terms:
Overweight
Spinal Cord Injuries
Body Weight
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014