Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+ (GLB-SCI+)
7 марта 2022 г. обновлено: 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.
Обзор исследования
Статус
Активный, не рекрутирующий
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
128
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Texas
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Dallas, Texas, Соединенные Штаты, 75246
- Baylor Scott & White Institute for Rehabilitation - Dallas
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Нерандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Экспериментальный: 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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Экспериментальный: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in weight
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in waist circumference
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Group meeting attendance
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 июня 2019 г.
Первичное завершение (Действительный)
19 октября 2021 г.
Завершение исследования (Ожидаемый)
1 июня 2022 г.
Даты регистрации исследования
Первый отправленный
7 февраля 2019 г.
Впервые представлено, что соответствует критериям контроля качества
13 марта 2019 г.
Первый опубликованный (Действительный)
14 марта 2019 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
8 марта 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
7 марта 2022 г.
Последняя проверка
1 февраля 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 018-783
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Сроки обмена 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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Portion-Controlled Meals
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Julien MaillardUniversity of Geneva, Switzerland; Ecole Polytechnique Fédérale de LausanneЗавершенный