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

Baylor Scott and White Health (BSWH)

Status: Active, not recruiting

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

Treatments: Behavioral: Enhanced Self-Monitoring; Behavioral: Portion-Controlled Meals; Behavioral: GLB-SCI+; Behavioral: GLB-SCI

Study type: Interventional

Funder types: Other

Identifiers

NCT03874988

018-783

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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128 participants in 4 patient groups

Portion-Controlled Meals

Experimental group

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.

Treatment:

Behavioral: Portion-Controlled Meals

Enhanced Self-Monitoring

Experimental group

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.

Treatment:

Behavioral: Enhanced Self-Monitoring

GLB-SCI

Experimental group

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.

Treatment:

Behavioral: GLB-SCI

GLB-SCI+

Experimental group

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.

Treatment:

Behavioral: GLB-SCI+