Clinical trial NCT03874988: Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+
Official title: Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Obesity
Weight Loss
Diet Modification
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study's overarching aim is to follow a systematic approach that incorporates community-based participatory research (CBPR) to develop a multi-component weight loss intervention that may yield significant effects for a chronic SCI sample. The approach is to obtain data on the 3 unique strategies (prepackaged/portion-controlled meals; enhanced self-monitoring; the GLB-SCI) to inform design of an empirically supported and consumer-validated multicomponent intervention program, that combines the best of the 3 approaches into one unique intervention, the GLB SCI+. Based on the investigators' prior experience with adapting and delivering the GLB AIM (a lifestyle intervention previously adapted for those with impaired mobility), interim findings, existing literature, and consumer feedback, they hypothesize that these 3 unique strategies may confer individualized benefits to people with SCI given their complex disability-related barriers to weight loss.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Have had a spinal cord injury for at least 1 year
* Overweight as evidenced by BMI \> 25
* Must have sufficient upper arm mobility to engage in exercise
* Must have access to the internet
* Must be able to obtain physician signed clearance to participate in a weight management intervention

Exclusion Criteria:

* Cognitive impairment which substantially impairs autonomy (e.g. mental retardation)
* Medical issues for which exercise is contraindicated such as uncontrolled hypertension or coronary heart disease,
* Pregnancy
* Not fluent in English
* Presence of grade 3 or 4 pressure ulcer
* Previously diagnosed eating disorder

Primary outcomes:
measure: Change in weight
timeFrame: Approximately every 13 weeks through study completion, expected to be 3 years.
measure: Change in physical activity level
timeFrame: Approximately every 13 weeks through study completion, expected to be 3 years.
measure: Self-efficacy
timeFrame: Approximately every 13 weeks through study completion, expected to be 3 years.
measure: Function/Quality of Life
timeFrame: Approximately every 13 weeks through study completion, expected to be 3 years.
Secondary outcomes:
measure: Change in waist circumference
timeFrame: Approximately every 13 weeks through study completion, expected to be 3 years.
measure: Change in blood pressure (systolic and diastolic)
timeFrame: Approximately every 13 weeks through study completion, expected to be 3 years.
measure: Change in hemoglobin A1c level
timeFrame: Approximately every 13 weeks through study completion, expected to be 3 years.
measure: Change in motivation for weight-loss
timeFrame: Approximately every 13 weeks through study completion, expected to be 3 years.
Other outcomes:
measure: Group meeting attendance
timeFrame: Attendance will be tracked over the entire 13-week intervention.
measure: Adherence to self-monitoring
timeFrame: Adherence will be tracked over the entire 13-week intervention.
measure: Individualized teleconference attendance
timeFrame: Attendance will be tracked over the entire 13-week intervention.
measure: Participant perceptions of each intervention
timeFrame: Perception will be assessed at the end of the 13-week intervention.
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation - Dallas
state: Texas
Study officials:
References: