OverweightNCT01467817
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
A study testing Lifestyle Intervention in people with Overweight and Obese, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obese, Spinal Cord Injury
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obesity/Overweight in Persons With Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention
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.
Read the 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.
- Conditions
- Overweight, Obese, Spinal Cord Injury
- Being tested
- Lifestyle Intervention, Exercise Control
- 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
- Medical subject headings
- Overweight, Obesity, Spinal Cord Injuries, Insulin Resistance, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
The intervention incorporates 6 months of active structured lifestyle intervention containing participant education, exercise, dietary intervention, and behavioral support
Exercise ControlBehavioural
The control group intervention will test benefits of exercise alone while controlling for investigator contact.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | This arm will test the combination of 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support. Receives: Behavioral: Lifestyle Intervention |
| Exercise Control | Placebo comparator | This arm will test the benefits of exercise alone while controlling for investigator contact. Receives: Behavioral: Exercise Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark S. Nash, Ph.D., FACSM, University of Miami
- Investigators
- Mark S Nash, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467817
- Sponsor's protocol ID
- TMP-MN-009
- Status last verified
- Feb 2016
- First submitted
- 26 Sep 2011
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity/Overweight in Persons With Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT01467817
- Acronym / sponsor ID
- TMP-MN-009
- Conditions
- Overweight, Obese, Spinal Cord Injury
- Keywords
- body mass, abdominal fat, whole body lean mass, insulin resistance, caloric intake, expenditure, endurance, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionThis arm will test the combination of 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support. |
| Exercise Control | Placebo comparator | Behavioral: Exercise ControlThis arm will test the benefits of exercise alone while controlling for investigator contact. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionThe intervention incorporates 6 months of active structured lifestyle intervention containing participant education, exercise, dietary intervention, and behavioral support | Behavioural | Lifestyle Intervention |
| Exercise ControlThe control group intervention will test benefits of exercise alone while controlling for investigator contact. | Behavioural | Exercise Control |
Primary outcome
Body mass
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Nash, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Overweight and Obese, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.