Recruiting

SSPANLI

Sponsor:

Mount Royal University

Code:

NCT01902979

Conditions

Lumbar Spinal Stenosis

Obesity

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Lifestyle intervention

Study Details

Brief summary:

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.

Conditions

Lumbar Spinal Stenosis

Obesity

Study ID

NCT01902979

Start date

Sep, 2013

Status verified date

Sep, 2013

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Usual Care

Interventions

Lifestyle intervention

Primary outcome measure

  • Change from Baseline in Percent Fat Mass at 6 months [ Time Frame: 6 months ]
  • Change from Baseline in Mean Number of Steps Per Day at 6 months [ Time Frame: 6 months ]
  • Change from Baseline in Waist Circumference (Centimeters) at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Mount Royal University

Recruiting

Calgary, Alberta, Canada, T2N 1T1

Contacts

Principal Investigator:

Christy C Tomkins-Lane, PhD

More Information

Sponsor

Mount Royal University

Last update posted

Sep 10, 2013

Last verified

Sep, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Royal University on 2013-09-10.