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

NCT01467817 | Completed DMC

• 1 other identifier: TMP-MN-009
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obese; Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Body mass

  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.

  12 months

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

This arm will test the combination of 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support.

Behavioral: Lifestyle Intervention

Exercise Control

PLACEBO COMPARATOR

This arm will test the benefits of exercise alone while controlling for investigator contact.

Behavioral: Exercise Control

Interventions

Lifestyle Intervention BEHAVIORAL

The intervention incorporates 6 months of active structured lifestyle intervention containing participant education, exercise, dietary intervention, and behavioral support

Lifestyle Intervention

Exercise Control BEHAVIORAL

The control group intervention will test benefits of exercise alone while controlling for investigator contact.

Exercise Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University Of Miami

Miami, Florida, 33136, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Overweight; Obesity; Spinal Cord Injuries; Insulin Resistance; Fasting

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• Mark S Nash, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: November 9, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-02

Locations

US (1)