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Portion-Controlled Meals for Weight Loss (GLB-SCI+ Trial)
N/A
Waitlist Available
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Over 18 years old
Have had a spinal cord injury for at least 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately every 13 weeks through study completion, expected to be 3 years.
Awards & highlights
GLB-SCI+ Trial Summary
This study is evaluating whether a combination of strategies may help individuals with spinal cord injury lose weight.
Eligible Conditions
- Weight Loss
- Spinal Cord Injury
- Obesity
- Diet Modification
GLB-SCI+ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGLB-SCI+ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately every 13 weeks through study completion, expected to be 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately every 13 weeks through study completion, expected to be 3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in physical activity level
Change in weight
Function/Quality of Life
+1 moreSecondary outcome measures
Body Weight Changes
Change in hemoglobin A1c level
Change in motivation for weight-loss
+1 moreOther outcome measures
Adherence to self-monitoring
Group meeting attendance
Individualized teleconference attendance
+1 moreGLB-SCI+ Trial Design
4Treatment groups
Experimental Treatment
Group I: Portion-Controlled MealsExperimental Treatment1 Intervention
Participants will receive prepackaged food, delivered biweekly to their home over the course of 13 weeks, with costs covered by the grant. Depending on their calorie goals, participants will drink and eat a mix of shakes and entrees each day, plus up to five fruits and vegetables. HMR entrees and shakes are formulated to provide recommended levels of macronutrients, vitamins, sodium, fat, cholesterol and fiber and fortified to meet at least 100% of the recommended daily allowance for essential vitamins and minerals.
Group II: GLB-SCI+Experimental Treatment1 Intervention
The final multicomponent GLB SCI+ will include combining specific intervention strategies identified from the previous 3 interventions as effective and usable. If all 3 strategies yield evidence in support of being included, the combined intervention would encompass (1) providing prepackaged foods for a specified period of time to facilitate greater initial weight loss, (2) encouraging enhanced self-monitoring of food, physical activity, and weight using devices and apps along with social support, and (3) delivering the further adapted GLB SCI in a group-based format to teach skills helpful in making lifestyle changes.
Group III: GLB-SCIExperimental Treatment1 Intervention
The content and delivery format of the developed GLB SCI lifestyle intervention program is subject to change based on guidance of the SCI Consumer Group. Therefore, this section provides a general description of the GLB AIM (lifestyle intervention program adapted for impaired mobility). The content of the GLB AIM core meetings include a mix of in-person (4) and telephone (9) sessions. The initial meeting is conducted in person, with one in-person sessions delivered each month, and the intervening weeks delivered by telephone. To achieve weight loss, participants will be encouraged to follow daily calorie and fat gram goals to achieve a .5 to 1 pound weight loss over the 13 weeks. Participants will also be encouraged to gradually increase their physical activity to ultimately achieve 150 weekly minutes.
Group IV: Enhanced Self-MonitoringExperimental Treatment1 Intervention
Participants will be encouraged to self-monitor 4 specific behaviors daily: 1) measuring their food; 2) measuring their physical activity; 3) recording their food, drink, and physical activity; and 4) monitoring their weight. To achieve this aim, participants will attend a single group-based educational session at baseline during which they will be provided the self-monitoring equipment (scale and Garmin vivofit) and receive training about how to use the Lilypad scale and smartphone food tracking app.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Portion-Controlled Meals
2018
N/A
~40
Find a Location
Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
198 Previous Clinical Trials
202,624 Total Patients Enrolled
3 Trials studying Weight Loss
138 Patients Enrolled for Weight Loss
Frequently Asked Questions
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