The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Mount Royal University
Sponsor:
Information provided by (Responsible Party):
Mount Royal University
ClinicalTrials.gov Identifier:
NCT01902979
First received: July 5, 2013
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

Obesity is one of the most important determinants of quality of life and function. People with lumbar spinal stenosis may be at increased risk of obesity given walking limitations. Spinal stenosis is a very common degenerative condition in people over 45. People with this condition have pain and numbness in the legs during walking, and therefore avoid physical activity. Lack of physical activity is related to weight gain and increased risk of chronic disease. Objective: The objective of this project is test a new e-health (online) pedometer and nutrition intervention aimed at promoting weight loss and increasing physical activity in overweight and obese individuals with spinal stenosis. Methods: The investigators will recruit 88 people with lumbar spinal stenosis who are overweight or obese. Half of these people will receive the 12-week intervention, and the other half will receive usual care (no intervention). In Weeks 1 and 6, people in the intervention group will meet with a Registered Dietitian and an Exercise Physiologist for personalized sessions. They will receive a pedometer and instructions on how to log in to the e-health site (https://sspanli.mtroyal.ca). They will wear the pedometer daily and log in to the website each week for a nutrition education session, a weekly step goal, and tips. The investigators will look to see whether people in the intervention group show greater change in physical activity, body composition and quality of life compared to the individuals who received usual care. Relevance: The increasing number of people with spinal stenosis represents a huge health care burden in Canada. This intervention could provide a new treatment option that would increase mobility, quality of life, and potentially alleviate the need for expensive treatments like surgery. E-health interventions provide an opportunity for patients to take an active role in their own health, and promote behaviour changes that will result in healthier Canadians less likely to access care in the future.


Condition Intervention
Lumbar Spinal Stenosis
Obesity
Behavioral: Lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Randomized Trial

Resource links provided by NLM:


Further study details as provided by Mount Royal University:

Primary Outcome Measures:
  • Change from Baseline in Percent Fat Mass at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Fat mass will be assessed at both Baseline and 6 month follow-up using dual energy x-ray absorptiometry and presented as a percentage of total body mass.

  • Change from Baseline in Mean Number of Steps Per Day at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Steps per day will be assessed at both Baseline and 6-month follow-up using a pedometer worn for 7 consecutive days

  • Change from Baseline in Waist Circumference (Centimeters) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Waist circumference will be assessed at both Baseline and 6-month follow-up using a tape measure and recorded in centimetres


Estimated Enrollment: 88
Study Start Date: September 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle intervention
In Weeks 1 and 6, people in the intervention group will meet with a Registered Dietitian and an Exercise Physiologist for personalized sessions. They will receive a pedometer and instructions on how to log in to the e-health site (https://sspanli.mtroyal.ca). They will wear the pedometer daily and log in to the website each week for a nutrition education session, a weekly step goal, and tips.
Behavioral: Lifestyle intervention
No Intervention: Usual Care

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects will be at least 45 years of age and will have received a diagnosis of lumbar spinal stenosis (LSS) by a spine surgeon who has both examined the patient and reviewed imaging results (MRI or CT). All subjects will be required to have a BMI of 25 kg/m2 or greater (overweight) and to have maintained a stable body weight for the previous 3 months.

Exclusion Criteria:

  • any co-morbid conditions that would make participation in a walking program medically inadvisable.
  • subjects currently participating in a diet or lifestyle intervention for weight loss or who are on medications known to influence bodyweight or glucoregulation (including antidepressants, sibutramine orlistate, insulin and metformin), will be excluded.

If participants are scheduled for any type of surgery that could impact mobility during the intervention period, they will be removed from the study.

  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: NCT01902979

Locations
Canada, Alberta
Mount Royal University Recruiting
Calgary, Alberta, Canada, T2N 1T1
Contact: Yvette Andreas    403-606-7021    1SSPANLI@gmail.com   
Principal Investigator: Christy C Tomkins-Lane, PhD         
Sponsors and Collaborators
Mount Royal University
Investigators
Principal Investigator: Christy Tomkins-Lane Mount Royal University
  More Information

No publications provided by Mount Royal University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mount Royal University
ClinicalTrials.gov Identifier: NCT01902979     History of Changes
Other Study ID Numbers: CIHR290928
Study First Received: July 5, 2013
Last Updated: September 9, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Spinal Stenosis
Constriction, Pathologic
Obesity
Pathological Conditions, Anatomical
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 25, 2014