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

Obesity Clinical Trial

— GLB-SCI+  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03874988
• Other study ID #: 018-783
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 2022

Study information

• Verified date: February 2022
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: June 2022
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diet Modification
• Obesity
• Spinal Cord Injuries
• Weight Loss

Intervention

Behavioral:
• Portion-Controlled Meals
Participants will receive portion-controlled meals with the aim of encouraging weight loss and healthier eating.
• Enhanced Self-Monitoring
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-SCI
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+
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.

Locations

Country	Name	City	State
United States	Baylor Scott & White Institute for Rehabilitation - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Group meeting attendance	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.	Attendance will be tracked over the entire 13-week intervention.
Other	Adherence to self-monitoring	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.	Adherence will be tracked over the entire 13-week intervention.
Other	Individualized teleconference attendance	Intervention arms involving teleconference meeting attendance will have levels of adherence tracked to examine correlations between attendance and weight-loss.	Attendance will be tracked over the entire 13-week intervention.
Other	Participant perceptions of each intervention	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	Perception will be assessed at the end of the 13-week intervention.
Primary	Change in weight	Change in weight (pounds) will be measured after each 13-week intervention.	Approximately every 13 weeks through study completion, expected to be 3 years.
Primary	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.	Approximately every 13 weeks through study completion, expected to be 3 years.
Primary	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.	Approximately every 13 weeks through study completion, expected to be 3 years.
Primary	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.	Approximately every 13 weeks through study completion, expected to be 3 years.
Secondary	Change in waist circumference	Participants will have their waist circumference measured before and after each intervention to assess the level of change, if any.	Approximately every 13 weeks through study completion, expected to be 3 years.
Secondary	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.	Approximately every 13 weeks through study completion, expected to be 3 years.
Secondary	Change in hemoglobin A1c level	Participants will have their hemoglobin A1c measured before and after each intervention assess the level of change, if any.	Approximately every 13 weeks through study completion, expected to be 3 years.
Secondary	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.	Approximately every 13 weeks through study completion, expected to be 3 years.