## Protocol Section
### Identification Module
**NCT ID:** NCT01902979

**Acronym:** SSPANLI

**Brief Title:** The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial

**Official Title:** The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Randomized Trial

#### Organization Study ID Info
**ID:** CIHR290928
#### Organization
**Class:** OTHER
**Full Name:** Mount Royal University
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2013-09-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-09-09

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2015-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-09

**Status Verified Date:** 2013-09

#### Study First Post Date
**Date:** 2013-07-18
**Type:** ESTIMATED
**Study First Submit Date:** 2013-07-05
**Study First Submit QC Date:** 2013-07-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mount Royal University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Lumbar Spinal Stenosis

- Obesity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 88

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Lifestyle intervention

**Label:** Lifestyle intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** Usual Care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lifestyle intervention

**Name:** Lifestyle intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change from Baseline in Percent Fat Mass at 6 months

**Time Frame:** 6 months

**Description:** Steps per day will be assessed at both Baseline and 6-month follow-up using a pedometer worn for 7 consecutive days

**Measure:** Change from Baseline in Mean Number of Steps Per Day at 6 months

**Time Frame:** 6 months

**Description:** Waist circumference will be assessed at both Baseline and 6-month follow-up using a tape measure and recorded in centimetres

**Measure:** Change from Baseline in Waist Circumference (Centimeters) at 6 months

**Time Frame:** 6 months

### Eligibility Module

**Eligibility 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.

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Calgary

**Contacts:**

***Contact 1:***

- **Email:** 1SSPANLI@gmail.com

- **Name:** Yvette Andreas

- **Phone:** 403-606-7021

- **Role:** CONTACT

***Contact 2:***

- **Name:** Christy C Tomkins-Lane, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** Mount Royal University

**State:** Alberta

**Status:** RECRUITING

**Zip:** T2N 1T1

#### Overall Officials

**Official 1:**

**Affiliation:** Mount Royal University

**Name:** Christy Tomkins-Lane

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Tomkins-Lane CC, Lafave LM, Parnell JA, Krishnamurthy A, Rempel J, Macedo LG, Moriartey S, Stuber KJ, Wilson PM, Hu R, Andreas YM. The spinal stenosis pedometer and nutrition lifestyle intervention (SSPANLI) randomized controlled trial protocol. BMC Musculoskelet Disord. 2013 Nov 14;14:322. doi: 10.1186/1471-2474-14-322.

**PMID:** 24228747

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: HIGH

- As Found: Stenosis

- ID: M15927

- Name: Spinal Stenosis

- Relevance: HIGH

- As Found: Spinal Stenosis

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013130

- Term: Spinal Stenosis

- ID: D000003251

- Term: Constriction, Pathologic

### Misc Info Module

- Version Holder: 2024-05-24
