Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+ (GLB-SCI+)
2022年3月7日 更新者：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.
研究概览
地位
主动，不招人
研究类型
介入性
注册 (预期的)
128
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Texas
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Dallas、Texas、美国、75246
- Baylor Scott & White Institute for Rehabilitation - Dallas
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Participants will receive portion-controlled meals with the aim of encouraging weight loss and healthier eating.
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实验性的：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.
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Participants will be encouraged to track their physical activity, food intake, and weight using technology that will be provided as part of the study.
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实验性的：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.
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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.
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实验性的：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in weight
大体时间：Approximately every 13 weeks through study completion, expected to be 3 years.
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Change in weight (pounds) will be measured after each 13-week intervention.
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Approximately every 13 weeks through study completion, expected to be 3 years.
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Change in physical activity level
大体时间：Approximately every 13 weeks through study completion, expected to be 3 years.
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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.
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Approximately every 13 weeks through study completion, expected to be 3 years.
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Self-efficacy
大体时间：Approximately every 13 weeks through study completion, expected to be 3 years.
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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.
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Approximately every 13 weeks through study completion, expected to be 3 years.
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Function/Quality of Life
大体时间：Approximately every 13 weeks through study completion, expected to be 3 years.
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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.
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Approximately every 13 weeks through study completion, expected to be 3 years.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in waist circumference
大体时间：Approximately every 13 weeks through study completion, expected to be 3 years.
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Participants will have their waist circumference measured before and after each intervention to assess the level of change, if any.
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Approximately every 13 weeks through study completion, expected to be 3 years.
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Change in blood pressure (systolic and diastolic)
大体时间：Approximately every 13 weeks through study completion, expected to be 3 years.
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Participants will have their blood pressure measured before and after each intervention to assess the level of change, if any.
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Approximately every 13 weeks through study completion, expected to be 3 years.
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Change in hemoglobin A1c level
大体时间：Approximately every 13 weeks through study completion, expected to be 3 years.
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Participants will have their hemoglobin A1c measured before and after each intervention assess the level of change, if any.
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Approximately every 13 weeks through study completion, expected to be 3 years.
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Change in motivation for weight-loss
大体时间：Approximately every 13 weeks through study completion, expected to be 3 years.
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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.
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Approximately every 13 weeks through study completion, expected to be 3 years.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Group meeting attendance
大体时间：Attendance will be tracked over the entire 13-week intervention.
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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.
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Attendance will be tracked over the entire 13-week intervention.
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Adherence to self-monitoring
大体时间：Adherence will be tracked over the entire 13-week intervention.
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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.
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Adherence will be tracked over the entire 13-week intervention.
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Individualized teleconference attendance
大体时间：Attendance will be tracked over the entire 13-week intervention.
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Intervention arms involving teleconference meeting attendance will have levels of adherence tracked to examine correlations between attendance and weight-loss.
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Attendance will be tracked over the entire 13-week intervention.
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Participant perceptions of each intervention
大体时间：Perception will be assessed at the end of the 13-week intervention.
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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
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Perception will be assessed at the end of the 13-week intervention.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年6月1日
初级完成 (实际的)
2021年10月19日
研究完成 (预期的)
2022年6月1日
研究注册日期
首次提交
2019年2月7日
首先提交符合 QC 标准的
2019年3月13日
首次发布 (实际的)
2019年3月14日
研究记录更新
最后更新发布 (实际的)
2022年3月8日
上次提交的符合 QC 标准的更新
2022年3月7日
最后验证
2022年2月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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.
IPD 共享时间框架
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.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.