Addressing Diabetes by Elevating Access to Nutrition: The ADELANTE Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 233
- 试验地点
- 3
- 主要终点
- HgbA1c
研究概览
简要总结
The goal of ADELANTE is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes.
Specifically, ADELANTE aims to
- determine whether weekly household food delivery plus an intensive lifestyle intervention is more effective than usual care for improving glycemic control (HbA1c) at 6 months,
- examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and
- assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.
详细描述
Participants and up to two of their household members will be randomized to one of two groups:
- healthy food box home delivery for 12 weeks plus a 12-month remotely delivered lifestyle behavioral intervention, Vida Sana, which incorporates family members and is aligned with Latino cultural values, or
- a wait list control group who will receive the food box deliveries 6 months later (but not the Vida Sana intervention).
The first 6 months will evaluate the effects of receiving Vida Sana plus food delivery versus being randomized to control (no intervention); the final 6 months will evaluate receiving food delivery with versus without Vida Sana.
VIDA SANA (intervention arm):
The Vida Sana intervention is a cultural adaptation of Group Lifestyle Balance, a 12-month group program in turn adapted from the NIH/NIDDK-supported Diabetes Prevention Program (DPP). It has been shown to be effective in promoting clinically significant, modest weight loss and significant improvements in moderate-intensity physical activity. Participants receive a total of 23 group sessions over 12 months with a trained health coach who provides personalized feedback based on self-tracking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will know which group they have been randomized to. The investigator and statistician will not know to which group a participant belongs. Group identifiers will be removed prior to analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For main study (index/intervention) participants:
- •Age at enrollment: 18+ years
- •Self-identified ethnicity: Hispanic, Latino, Chicano, or Spanish
- •Type 2 diabetes indicated in the electronic health record, e.g. as ICD-10 (International Classification of Diseases) diagnosis code or HbA1c value
- •Have indicated food insecurity according to the screening 2-item Hunger Vital Sign questionnaire
- •Have a Body Mass Index (BMI) => 25
- •Receiving care at our partnering community health centers (e.g., Clinica de la Raza)
- •Currently residing in Alameda or Contra Costa County and not expecting to relocate in the next 6-12 months
- •Have access to phone or computer, email, and some internet for access to remote intervention and completion of follow-up measures
- •For household members:
- •Age at enrollment: 12+ years
- •Significantly involved in supporting nutrition in the home including food shopping, preparation, social support for healthy nutrition
- •Willing to complete some questionnaires and attend a single group session.
- •For all participants:
- •Able and willing to provide informed consent
排除标准
- •Unable to provide informed consent
- •Unable to speak, read, or understand English and/or Spanish
- •Active substance use or psychotic disorders that would impair participation in a group lifestyle intervention or interfere with follow-up assessments
- •Lacking mailing address for delivery of food box
- •Planning to relocate out of area within the next 12 months
- •Index participant only: Pregnant or planning to become pregnant within the next 12 months
研究组 & 干预措施
Food and Lifestyle Intervention Group
The Food and Lifestyle Intervention Group will receive weekly household deliveries of healthy food as well as a lifestyle intervention (called Vida Sana) that will be delivered via Zoom and facilitated by a trained bilingual/bicultural health coach.
干预措施: Vida Sana (a Group Lifestyle Intervention) (Behavioral)
Food and Lifestyle Intervention Group
The Food and Lifestyle Intervention Group will receive weekly household deliveries of healthy food as well as a lifestyle intervention (called Vida Sana) that will be delivered via Zoom and facilitated by a trained bilingual/bicultural health coach.
干预措施: Supplemental Healthy Food Deliveries (Behavioral)
Waitlist Control Group
The waitlist control will continue usual care with no intervention for 6 months. To balance rigor with ethical considerations, they will receive the healthy food box deliveries after a 6 month waiting period.
干预措施: Supplemental Healthy Food Deliveries (Behavioral)
结局指标
主要结局
HgbA1c
时间窗: Baseline through 12 months post-enrollment
Study staff will gather fingerstick blood samples for HgbA1c.
次要结局
- nonHDL Cholesterol(Baseline through 12 months post-enrollment)
- Health-related quality of life (adolescent household members only)(Baseline through 12 months post-enrollment)
- Blood Pressure(Baseline through 12 months post-enrollment)
- Change in Body Mass Index (BMI)(Baseline through 12 months post-enrollment)
- Depression(Baseline through 12 months post-enrollment)
- Depression (index participant only)(Baseline through 12 months post-enrollment)
- Dietary Intake Over 24 Hour Period (index participants only)(Baseline through 12 months post-enrollment)
- Diet-Related Behaviors: Food Preferences & Consumption(Baseline through 12 months post-enrollment)
- Control Over Food Choices(Baseline through 12 months post-enrollment)
- Pandemic-Related Perceived Stress Scale of COVID-19 (PSS-10-C)(Baseline through 12 months post-enrollment)
- Changes in Diet-Related Behaviors(6 months through 12 months post-enrollment)
- Nutrition Security Screener(Baseline through 12 months post-enrollment)
- Change in waist-height ratio(Baseline through 12 months post-enrollment)
- Type 2 Diabetes Mellitus Related Stress(Baseline through 12 months post-enrollment)
- Health-related quality of life (adult participants only)(Baseline through 12 months post-enrollment)
- Change in physical activity(Baseline through 12 months post-enrollment)
- Interest in Community Supported Agriculture (CSA) Programs(Baseline through 12 months post-enrollment)
- Household Food Insecurity(Baseline through 12 months post-enrollment)
- Anxiety(Baseline through 12 months post-enrollment)
- Self-reported Loneliness(Baseline through 12 months post-enrollment)
- Dietary Intake (household members only)(Baseline through 12 months post-enrollment)
- Food Neophobia Scale (FNS)(Baseline through 12 months post-enrollment)
- Food Assistance Programs(Baseline through 12 months post-enrollment)
研究者
Lisa Goldman Rosas
Principal Investigator, Assistant Professor, Department of Health Research and Policy (Epidemiology) and Medicine (Primary Care and Population Health) Faculty Director, Office of Community Engagement Stanford School of Medicine
Stanford University