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Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+ (GLB-SCI+)

Primary Purpose

Spinal Cord Injuries, Obesity, Weight Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portion-Controlled Meals
Enhanced Self-Monitoring
GLB-SCI
GLB-SCI+
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baylor Scott & White Institute for Rehabilitation - Dallas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Portion-Controlled Meals

Enhanced Self-Monitoring

GLB-SCI

GLB-SCI+

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in weight
Change in weight (pounds) will be measured after each 13-week intervention.
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.
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.
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.

Secondary Outcome Measures

Change in waist circumference
Participants will have their waist circumference measured before and after each intervention to assess the level of change, if any.
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.
Change in hemoglobin A1c level
Participants will have their hemoglobin A1c measured before and after each intervention assess the level of change, if any.
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.

Full Information

First Posted
February 7, 2019
Last Updated
March 7, 2022
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03874988
Brief Title
Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+
Acronym
GLB-SCI+
Official Title
Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 19, 2021 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Obesity, Weight Loss, Diet Modification

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Portion-Controlled Meals
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Self-Monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
GLB-SCI
Arm Type
Experimental
Arm Description
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.
Arm Title
GLB-SCI+
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Portion-Controlled Meals
Intervention Description
Participants will receive portion-controlled meals with the aim of encouraging weight loss and healthier eating.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Self-Monitoring
Intervention Description
Participants will be encouraged to track their physical activity, food intake, and weight using technology that will be provided as part of the study.
Intervention Type
Behavioral
Intervention Name(s)
GLB-SCI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
GLB-SCI+
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in weight
Description
Change in weight (pounds) will be measured after each 13-week intervention.
Time Frame
Approximately every 13 weeks through study completion, expected to be 3 years.
Title
Change in physical activity level
Description
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.
Time Frame
Approximately every 13 weeks through study completion, expected to be 3 years.
Title
Self-efficacy
Description
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.
Time Frame
Approximately every 13 weeks through study completion, expected to be 3 years.
Title
Function/Quality of Life
Description
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.
Time Frame
Approximately every 13 weeks through study completion, expected to be 3 years.
Secondary Outcome Measure Information:
Title
Change in waist circumference
Description
Participants will have their waist circumference measured before and after each intervention to assess the level of change, if any.
Time Frame
Approximately every 13 weeks through study completion, expected to be 3 years.
Title
Change in blood pressure (systolic and diastolic)
Description
Participants will have their blood pressure measured before and after each intervention to assess the level of change, if any.
Time Frame
Approximately every 13 weeks through study completion, expected to be 3 years.
Title
Change in hemoglobin A1c level
Description
Participants will have their hemoglobin A1c measured before and after each intervention assess the level of change, if any.
Time Frame
Approximately every 13 weeks through study completion, expected to be 3 years.
Title
Change in motivation for weight-loss
Description
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.
Time Frame
Approximately every 13 weeks through study completion, expected to be 3 years.
Other Pre-specified Outcome Measures:
Title
Group meeting attendance
Description
Intervention arms involving meeting on a regular basis will have attendance tracked to assess the overall feasibility of the intervention and to examine correlations between self-monitoring and weight-loss.
Time Frame
Attendance will be tracked over the entire 13-week intervention.
Title
Adherence to self-monitoring
Description
Intervention arms involving self-monitoring food intake and physical activity will have levels of adherence tracked to assess the overall feasibility of the intervention and to examine correlations between self-monitoring and weight-loss.
Time Frame
Adherence will be tracked over the entire 13-week intervention.
Title
Individualized teleconference attendance
Description
Intervention arms involving teleconference meeting attendance will have levels of adherence tracked to examine correlations between attendance and weight-loss.
Time Frame
Attendance will be tracked over the entire 13-week intervention.
Title
Participant perceptions of each intervention
Description
Participant perceptions will be assessed using a survey that asks participants to rate on a scale of 1 - 5 each active component used in each study
Time Frame
Perception will be assessed at the end of the 13-week intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Baylor Scott & White Institute for Rehabilitation - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
1 year after completion of all study activities. The research data from this project will be deposited with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR) to ensure that the research community has long-term access to the data.

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Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+

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