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

7 mars 2022 mis à jour par: Baylor Research Institute
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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

128

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Texas
      • Dallas, Texas, États-Unis, 75246
        • Baylor Scott & White Institute for Rehabilitation - Dallas

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Portion-Controlled Meals
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.
Comportemental: Portion-Controlled Meals
Participants will receive portion-controlled meals with the aim of encouraging weight loss and healthier eating.
Expérimental: Enhanced Self-Monitoring
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.
Comportemental: 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.
Expérimental: GLB-SCI
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.
Comportemental: 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.
Expérimental: GLB-SCI+
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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in weight
Délai: Approximately every 13 weeks through study completion, expected to be 3 years.
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
Délai: 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.
Approximately every 13 weeks through study completion, expected to be 3 years.
Self-efficacy
Délai: 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.
Approximately every 13 weeks through study completion, expected to be 3 years.
Function/Quality of Life
Délai: 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.
Approximately every 13 weeks through study completion, expected to be 3 years.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in waist circumference
Délai: 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.
Approximately every 13 weeks through study completion, expected to be 3 years.
Change in blood pressure (systolic and diastolic)
Délai: 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.
Approximately every 13 weeks through study completion, expected to be 3 years.
Change in hemoglobin A1c level
Délai: 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.
Approximately every 13 weeks through study completion, expected to be 3 years.
Change in motivation for weight-loss
Délai: 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.
Approximately every 13 weeks through study completion, expected to be 3 years.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Group meeting attendance
Délai: Attendance will be tracked over the entire 13-week intervention.
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.
Adherence to self-monitoring
Délai: Adherence will be tracked over the entire 13-week intervention.
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.
Individualized teleconference attendance
Délai: Attendance will be tracked over the entire 13-week intervention.
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.
Participant perceptions of each intervention
Délai: Perception will be assessed at the end of the 13-week 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Baylor Research Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2019

Achèvement primaire (Réel)

19 octobre 2021

Achèvement de l'étude (Anticipé)

1 juin 2022

Dates d'inscription aux études

Première soumission

7 février 2019

Première soumission répondant aux critères de contrôle qualité

13 mars 2019

Première publication (Réel)

14 mars 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 mars 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 mars 2022

Dernière vérification

1 février 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 018-783

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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