WE Project: 2.0 Grassroots Wellness Coaching. Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management (Phase 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Participants in the intervention ward will manifest clinically significant Change in diet behavioral outcomes targeted in the intervention.
研究概览
简要总结
African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and improve cardiometabolic health outcomes for the study population. The purpose of this research study is to find out about the feasibility, acceptability and preliminary effectiveness of using house chats (HC) as a model for a weight management program in a real-world, community-based setting.
详细描述
The pilot trial will utilize a cluster randomized controlled design to assess the feasibility, acceptability, and preliminary effectiveness of the house chat model as a grassroots approach to lifestyle intervention delivery in a community setting. Four wards will be randomly assigned to either intervention or a delayed intervention control. A total of 10 HCL will be recruited and trained across the two wards (5 in the intervention ward and 5 in delayed intervention ward). HCL will recruit members of their social network (>18 years of age) to participate in a 12-week lifestyle intervention delivered via weekly group meetings in the HCL's homes. The primary goal is to understand the feasibility and acceptability of this novel approach to intervention delivery, and as such, process data on recruitment, training, fidelity of intervention delivery, and satisfaction with the sessions will be collected on a weekly basis. In addition, in-person assessment visits will take place at 0, 12 weeks (post-treatment) and 24 weeks (follow up) to determine the preliminary effectiveness of this intervention to promote positive changes on adiposity (weight and waist circumference), other cardiometabolic risk factors (e.g., fasting glucose) and behavioral risk factors (physical activity and diet quality). In addition, the investigators will employ a mixed methods approach (process data, surveys, in-depth interviews with HCL, participants and key stakeholders) to assess factors that might promote and / or interfere with sustainability over long-term follow up to inform our future clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Four wards will be randomly assigned to either intervention or a delayed intervention control. A total of 10 HCL will be recruited and trained across the two wards (5 in the intervention ward and 5 in delayed intervention ward).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 or older
- •Resident of Petersburg, VA
排除标准
- •Dx of type 1 diabetes mellitus
- •Current treatment for cancer
- •Medical conditions that may increase risk for participating in unsupervised physical activity unless medical provider provides consent for participation
- •Hospitalization for depression or other psychiatric disorder within the past 12 months
- •Uncontrolled psychotic disorder or bipolar disorder
- •Currently pregnant or lactating or planning to become pregnant within the study period
- •Current involvement in a weight loss program or current use of weight loss medication
- •Inability to speak and read English
- •Planning to move from the Petersburg area within the study period
研究组 & 干预措施
Delayed Intervention Control
Participants will be randomized to delayed intervention control and will receive the same 12-week program following the 24-week assessment.
干预措施: 12-week lifestyle intervention (Behavioral)
Intervention
Participants will be randomized to intervention and will receive the 12-week program.
干预措施: 12-week lifestyle intervention (Behavioral)
结局指标
主要结局
Participants in the intervention ward will manifest clinically significant Change in diet behavioral outcomes targeted in the intervention.
时间窗: 12 week and 24 weeks post-treatment
The EARLY Trials 4-item Sugar Sweetened Beverage Questionnaire and 10-item NCI fruit and vegetable screener (all day version) to assess changes in core intervention targets will be administered. While any changes in these outcomes would be meaningful if sustained over time, the results will compare to current guidelines / recommendations. Specifically, changing sugar intake no more than 9 teaspoons/36 grams/150 calories for men and 6 teaspoons/25 grams/100 calories for women per and increasing fruit and vegetable intake to at least 5 total servings per day are consistent with current guidelines.
Intervention ward participants will manifest clinically significant change in adiposity
时间窗: 12 week and 24 weeks post-treatment
The thresholds for clinically meaningful will be different based on baseline weight status. For those without overweight or obesity staying within 1lb of baseline weight would be considered clinically meaningful. For absolute change in body mass index and percent change of initial body weight we will report the results stratified by weight status (BMI \> 25 or BMI \< 25) since weight management targets would be distinct for those with overweight / obesity vs. those classified as healthy weight (weight loss vs. weight gain prevention, respectively).\] Weight will be measured with the Tanita BWB 800 digital portable scale . BMI will be calculated using the obtained weight and height measurements. Weight will be measured with the scale noted above and height will be measure via the Seca 213 portable stadiometer. Then, we will calculate BMI using the body mass index (kg/m2) = (average weight in kg) / (average height in m)2.
Subjects will manifest clinically significant change in Secondary markers of cardiometabolic risk through changed blood pressure readings
时间窗: 12 week and 24 weeks post-treatment
Clinically significant changes in blood pressure include a systolic blood pressure (SBP) changing ≥ 10mmHg or a diastolic blood pressure (DBP) changing ≥ 5mmHg as this can change the category that a participant's blood pressure is categorized as. Please see the table below from AHA for reference. We will measure blood pressure using the GE Carescape V100 Monitor and Gulick II Tape Measure.
Participants in the intervention ward will manifest clinically significant change in physical activity outcomes targeted in the intervention.
时间窗: 12 week and 24 weeks post-treatment
Physical activity will be objectively assessed via accelerometers. Total minutes of physical activity is the main outcome, but will also examine minutes of light and moderate-to-vigorous physical activity. The threshold for clinically meaningful is 150 minutes / week which is consistent with a wealth of evidence and current evidence-based guidelines.
Subjects will manifest clinically significant change in secondary markers of cardiometabolic risk with changed Fasting Glucose Values
时间窗: 12 week and 24 weeks post-treatment
Fasting glucose values are categorized as within normal range (≤ 99 mg/dL), in prediabetes stage (100-125 mg/dL), or having diabetes (≥ 126 mg/dL). A change for those that are in the prediabetes or diabetes categories will include their follow up values decreasing, while for those that are found to be in the normal range at baseline we will want them to maintain. Fasting glucose will be measured using the ACCU-CHEK Inform II Meter and ACCU-CHEK Inform II Test Strips.
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.
时间窗: 12 week and 24 weeks post-treatment
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.
Participants in the intervention will manifest clinically significant improvements in waist circumference with a signal for differential benefit compared to delayed intervention participants.
时间窗: 12 week and 24 weeks post-treatment
Waist circumference will be measured using a Gulik tape measure at the midpoint between the highest point of the iliac crest and the lowest part of the costal margin in the mid-axillary line.
Participants will experience clinically significant improvements in fasting glucose with a signal for differential benefit compared to delayed intervention participants.
时间窗: 12 week and 24 weeks post-treatment
Finger-prick blood sample via a point-of-care Accu-Check glucometer will be used to obtain fasting glucose.
Participants in the intervention will manifest clinically significant change in physical activity outcomes targeted in the intervention.
时间窗: 12 week and 24 weeks post-treatment
Physical activity will be objectively assessed via accelerometers. Total minutes of physical activity is the main outcome, but we will also examine minutes of light and moderate-to-vigorous physical activity. The threshold for clinically meaningful is 150 minutes / week which is consistent with a wealth of evidence and current evidence-based guidelines.
Participants in the intervention ward will manifest clinically significant improvements in dietary quality outcomes targeted in the intervention.
时间窗: 12 week and 24 weeks post-treatment
The EARLY Trials 4-item Sugar Sweetened Beverage Questionnaire and 10-item NCI fruit and vegetable screener (all day version) to assess changes in core intervention targets will be administered. While any changes improvements in these outcomes would be meaningful if sustained over time, the results we will also will compare to current American Heart Association guidelines / recommendations
次要结局
未报告次要终点