Spinal Cord InjuriesGLB-SCI+NCT03874988
Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+
A study testing Enhanced Self-Monitoring, GLB-SCI and GLB-SCI+ in people with Spinal Cord Injuries and Obesity, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Obesity, Weight Loss
- What is being tested?
- Enhanced Self-Monitoring, GLB-SCI and GLB-SCI+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Institute for Rehabilitation - Dallas
Dallas, Texas, 75246
About this study
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.
- Conditions
- Spinal Cord Injuries, Obesity, Weight Loss, Diet Modification
- Being tested
- Portion-Controlled Meals, Enhanced Self-Monitoring, GLB-SCI, GLB-SCI+
- Medical subject headings
- Spinal Cord Injuries, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portion-Controlled MealsBehavioural
Participants will receive portion-controlled meals with the aim of encouraging weight loss and healthier eating.
Enhanced Self-MonitoringBehavioural
Participants will be encouraged to track their physical activity, food intake, and weight using technology that will be provided as part of the study.
GLB-SCIBehavioural
Participants will take part in a lifestyle intervention program (tailored for spinal cord injury needs) that encourages steady weight loss through increased physical activity and healthier diet patterns.
GLB-SCI+Behavioural
Participants will receive a combination of the prior interventions studied, with the goal of showing that a multi-component intervention will be the most effective in encouraging weight loss among participants with a spinal cord injury.
| Study group | Role | What they receive |
|---|---|---|
| Portion-Controlled Meals | Experimental | 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. Receives: Behavioral: Portion-Controlled Meals |
| Enhanced Self-Monitoring | Experimental | 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. Receives: Behavioral: Enhanced Self-Monitoring |
| GLB-SCI | Experimental | 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. Receives: Behavioral: GLB-SCI |
| GLB-SCI+ | Experimental | 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. Receives: Behavioral: GLB-SCI+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Change in weight (pounds) will be measured after each 13-week intervention.
Measured: Approximately every 13 weeks through study completion, expected to be 3 years.
Change in physical activity level
Change in self-reported physical activity (minutes per week) will be measured after each 13-week intervention to assess whether the intervention effectively encouraged greater levels of physical activity.
Measured: Approximately every 13 weeks through study completion, expected to be 3 years.
Self-efficacy
Self-efficacy will be measured through changes in the Self-Rated Abilities for Health Practices Scale from baseline to post-intervention. The questionnaire contains 28 items that are on a 5-point scale. It was designed to measure a person's perception of his/her own ability to practice "healthy" behaviors and has 4 sub-scales with 7 items each: Exercise, Nutrition, Responsible Health Practice, and Psychological Well Being. Ratings for each subscale are summed to yield subscale scores and subscale scores are summed to obtain a total score. Higher scores indicate greater confidence in one's ability to perform health practices and total scores range from 0-112.
Measured: Approximately every 13 weeks through study completion, expected to be 3 years.
Function/Quality of Life
Changes in self-reported levels of function and quality of life will be assessed through the LIFE-H survey, given before and after each intervention. The Assessment of Life Habits (LIFE-H) assesses a person's self-reported difficulty with and need for assistance performing tasks associated with activities of daily living (ADL) and social roles. The version used for this study covers 6 ADL categories: nutrition, fitness, personal care, communication, residence, mobility and 6 social role categories: responsibility, interpersonal relations, community, education, employment, recreation. Scoring is based on respondent rating of level of accomplishment (No difficulty to Not accomplished) combined with the type of assistance (if any) used to perform these tasks. Scores range from 9 to 0, with higher scores indicating less difficulty.
Measured: Approximately every 13 weeks through study completion, expected to be 3 years.
Secondary outcomes (4)
Change in waist circumference
Participants will have their waist circumference measured before and after each intervention to assess the level of change, if any.
Measured: Approximately every 13 weeks through study completion, expected to be 3 years.
Change in blood pressure (systolic and diastolic)
Participants will have their blood pressure measured before and after each intervention to assess the level of change, if any.
Measured: Approximately every 13 weeks through study completion, expected to be 3 years.
Change in hemoglobin A1c level
Participants will have their hemoglobin A1c measured before and after each intervention assess the level of change, if any.
Measured: Approximately every 13 weeks through study completion, expected to be 3 years.
Change in motivation for weight-loss
Participants will have their levels of motivation assessed before and after each intervention with the Treatment Self-Regulation Questionnaire. The 18-item Treatment Self-Regulation Questionnaire is derived from self-determination theory and yields 2 subscales: autonomous regulation (or intrinsic motivation) and controlled regulation (or extrinsic motivation). Responses are provided on a 7-point Likert type scale ranging from 1 'not at all true' to 7 'very true,' and includes the option of "not applicable." Autonomous Regulation scores are obtained by averaging questions 3, 4, 9, 13, 17, 18 and Controlled Regulation scores are obtained by averaging questions 1, 2, 5, 6, 7, 8, 10, 11, 12, 14, 15, 16. Higher scores indicate higher levels of motivation. Higher scores indicate higher levels of each type of regulation.
Measured: Approximately every 13 weeks through study completion, expected to be 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Jun 2019
- Primary completion19 Oct 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874988
- Sponsor's protocol ID
- 018-783
- Acronym
- GLB-SCI+
- Status last verified
- Oct 2025
- First submitted
- 7 Feb 2019
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This project will generate data designed to study the feasibility, effectiveness, and usability of several weight-loss strategies in a sample of approximately 100 participants with spinal cord injury. These data will be submitted to Inter-university Consortium for Political and Social Research (ICPSR). ICPSR will make the research data from this project available to the broader social science research community. These files, in which direct and indirect identifiers have been removed to minimize disclosure risk, may be accessed directly through the ICPSR website. After depositing the data, the dissemination will be delayed for one year to allow for the principal investigator and collaborators to complete major manuscripts related to the data. ICPSR will accept responsibility for long-term preservation of the research data upon receipt of a signed deposit form.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+
- ClinicalTrials.gov ID
- NCT03874988
- Acronym / sponsor ID
- GLB-SCI+ / 018-783
- Conditions
- Spinal Cord Injuries, Obesity, Weight Loss, Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Portion-Controlled Meals | Experimental | Behavioral: Portion-Controlled MealsParticipants 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. |
| Enhanced Self-Monitoring | Experimental | Behavioral: Enhanced Self-MonitoringParticipants 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. |
| GLB-SCI | Experimental | Behavioral: GLB-SCIThe 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. |
| GLB-SCI+ | Experimental | Behavioral: GLB-SCI+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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portion-Controlled MealsParticipants will receive portion-controlled meals with the aim of encouraging weight loss and healthier eating. | Behavioural | Portion-Controlled Meals |
| Enhanced Self-MonitoringParticipants will be encouraged to track their physical activity, food intake, and weight using technology that will be provided as part of the study. | Behavioural | Enhanced Self-Monitoring |
| GLB-SCIParticipants will take part in a lifestyle intervention program (tailored for spinal cord injury needs) that encourages steady weight loss through increased physical activity and healthier diet patterns. | Behavioural | GLB-SCI |
| GLB-SCI+Participants will receive a combination of the prior interventions studied, with the goal of showing that a multi-component intervention will be the most effective in encouraging weight loss among participants with a spinal cord injury. | Behavioural | GLB-SCI+ |
Primary outcome
Change in weight
Time frame: Approximately every 13 weeks through study completion, expected to be 3 years.
Change in weight (pounds) will be measured after each 13-week intervention.
Change in physical activity level
Time frame: Approximately every 13 weeks through study completion, expected to be 3 years.
Change in self-reported physical activity (minutes per week) will be measured after each 13-week intervention to assess whether the intervention effectively encouraged greater levels of physical activity.
Self-efficacy
Time frame: Approximately every 13 weeks through study completion, expected to be 3 years.
Self-efficacy will be measured through changes in the Self-Rated Abilities for Health Practices Scale from baseline to post-intervention. The questionnaire contains 28 items that are on a 5-point scale. It was designed to measure a person's perception of his/her own ability to practice "healthy" behaviors and has 4 sub-scales with 7 items each: Exercise, Nutrition, Responsible Health Practice, and Psychological Well Being. Ratings for each subscale are summed to yield subscale scores and subscale scores are summed to obtain a total score. Higher scores indicate greater confidence in one's ability to perform health practices and total scores range from 0-112.
Function/Quality of Life
Time frame: Approximately every 13 weeks through study completion, expected to be 3 years.
Changes in self-reported levels of function and quality of life will be assessed through the LIFE-H survey, given before and after each intervention. The Assessment of Life Habits (LIFE-H) assesses a person's self-reported difficulty with and need for assistance performing tasks associated with activities of daily living (ADL) and social roles. The version used for this study covers 6 ADL categories: nutrition, fitness, personal care, communication, residence, mobility and 6 social role categories: responsibility, interpersonal relations, community, education, employment, recreation. Scoring is based on respondent rating of level of accomplishment (No difficulty to Not accomplished) combined with the type of assistance (if any) used to perform these tasks. Scores range from 9 to 0, with higher scores indicating less difficulty.
4 secondary outcomes
Change in waist circumference
Time frame: Approximately every 13 weeks through study completion, expected to be 3 years.
Change in blood pressure (systolic and diastolic)
Time frame: Approximately every 13 weeks through study completion, expected to be 3 years.
Change in hemoglobin A1c level
Time frame: Approximately every 13 weeks through study completion, expected to be 3 years.
Change in motivation for weight-loss
Time frame: Approximately every 13 weeks through study completion, expected to be 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: Yes. This project will generate data designed to study the feasibility, effectiveness, and usability of several weight-loss strategies in a sample of approximately 100 participants with spinal cord injury. These data will be submitted to Inter-university Consortium for Political and Social Research (ICPSR). ICPSR will make the research data from this project available to the broader social science research community. These files, in which direct and indirect identifiers have been removed to minimize disclosure risk, may be accessed directly through the ICPSR website. After depositing the data, the dissemination will be delayed for one year to allow for the principal investigator and collaborators to complete major manuscripts related to the data. ICPSR will accept responsibility for long-term preservation of the research data upon receipt of a signed deposit form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Self-Monitoring, GLB-SCI and GLB-SCI+ in people with Spinal Cord Injuries and Obesity, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Approximately every 13 weeks through study completion, expected to be 3 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.