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

Not Applicable

• Conditions: Diet Modification; Spinal Cord Injuries; Weight Loss; Obesity

• Registration Number: NCT03874988
• Lead Sponsor: Baylor Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Study Start: 2019-06-01
• Primary Completion: 2021-10-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in weight	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in waist circumference	Approximately every 13 weeks through study completion, expected to be 3 years.	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)	Approximately every 13 weeks through study completion, expected to be 3 years.	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	Approximately every 13 weeks through study completion, expected to be 3 years.	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	Approximately every 13 weeks through study completion, expected to be 3 years.	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.

Trial Locations

Locations (1)

Baylor Scott & White Institute for Rehabilitation - Dallas; 🇺🇸 Dallas, Texas, United States