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

NCT03874988 | Completed

• 1 other identifier: 018-783
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Obesity; Weight Loss; Diet Modification

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (4)

• Change in waist circumference

  Approximately every 13 weeks through study completion, expected to be 3 years.

• Change in blood pressure (systolic and diastolic)

  Approximately every 13 weeks through study completion, expected to be 3 years.

• Change in hemoglobin A1c level

  Approximately every 13 weeks through study completion, expected to be 3 years.

• Change in motivation for weight-loss

  Approximately every 13 weeks through study completion, expected to be 3 years.

Other Outcomes (4)

• Group meeting attendance

  Attendance will be tracked over the entire 13-week intervention.

• Adherence to self-monitoring

  Adherence will be tracked over the entire 13-week intervention.

• Individualized teleconference attendance

  Attendance will be tracked over the entire 13-week intervention.

Study Arms (4)

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.

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.

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.

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.

Behavioral: GLB-SCI+

Interventions

Portion-Controlled Meals BEHAVIORAL

Participants will receive portion-controlled meals with the aim of encouraging weight loss and healthier eating.

Portion-Controlled Meals

Enhanced Self-Monitoring BEHAVIORAL

Participants will be encouraged to track their physical activity, food intake, and weight using technology that will be provided as part of the study.

Enhanced Self-Monitoring

GLB-SCI+ BEHAVIORAL

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.

GLB-SCI+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Institute for Rehabilitation - Dallas

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: March 14, 2019
• Study Start: June 1, 2019
• Primary Completion: October 19, 2021
• Study Completion: June 15, 2022
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

US (1)