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临床试验/NCT07808723
NCT07808723招募中不适用

Community Engaged Alliance-Reimagined Environments and Systems Together for Outcomes Georgia Through Research and Evaluation for Sustainability (RESTORES) - Georgia CEAL RESTORES

Morehouse School of Medicine1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年8月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Weight Reduction

研究概览

简要总结

The goal of this clinical trial is to determine whether a family-based lifestyle intervention reduces the risk of type 2 diabetes (T2D) among parents and their children. The intervention will also evaluate how well the program supports healthy lifestyle behaviors and family engagement.

The primary outcome of this study is weight loss in parents.

Researchers will evaluate changes in participants' weight and lifestyle behaviors before the study compared to the end of the study (12 weeks post intervention) and 3 months after participation in the program.

详细描述

The intervention will test the following hypothesis: a) Parents enrolled in the family intervention will demonstrate a 4% reduction in weight by the end of the intervention.

There will be three data collection time points for all enrolled participants: baseline (T1), post-intervention (12 weeks) (T2), and 3-month follow-up (T3). For each data collection time point, parents and children will complete questionnaires and clinical assessments. All survey data will be collected electronically using the secure research electronic data capture system (REDCap) which allows secure data capture from remote locations. Links to the surveys will be emailed to parents and children to access and complete intervention questionnaires or addition options to complete documentation using a study-issued iPad or laptop once the participants arrive for the clinical assessment day. The study questionnaires will collect participant demographics, health history, physical activity (amount, type, and related behaviors), sedentary behaviors, dietary intake, diet behaviors, weight loss history, quality of life, and perceived stress.

Clinical assessments will include the collection of weight, height, blood pressure, and waist circumference. Additionally, parents will have their weight assessed weekly during the intervention.

The family (one adult with prediabetes or risk factors for developing diabetes and a child between the ages of 12 and 17 years old) will be asked to attend 12 weekly sessions at a community site. Each session will last about two hours and will include a family meal. During the weekly sessions, 10 families will learn together how to improve their stress management, triggers, cognitive strategies, social support, eating, and physical activity habits. Parents and children will have some sessions together and others that are separate.

Each session will include 15-30 minutes of walking, dancing, playing sports, or other activities that move the body and increase the heart rate. Parents/guardians and children will go into separate rooms to learn about different topics each week. Some of the topics are exercise, healthy eating, cooking, and managing stress. At the end of each session, families will come together to share a meal.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parent/guardian must identify as African American or Hispanic, be 18+ years residing in the same household as the child (i.e., biological or have legal guardianship for child), have prediabetes (HbA1c level 5.7-6.4%) or determined to be at risk using CDC's Pre-Diabetes Risk Test, be willing to commit to participation in a 12-week intervention study, have no plans to move over the next 9-months, and are ambulatory and able to participate in physical activity. Children must be between the ages of 12-17 years old and are ambulatory and able to participate in physical activity.

排除标准

  • Participants will be excluded from the research study if the participant has severe psychological disorders that may prevent/interfere with study participation, physical impairments that may prevent participation in moderate intensity physical activity, have previous diagnosis of diabetes, have a history of congestive heart failure, renal failure, or recent (<12 months) cardiovascular events such as myocardial infarction (heart attack) or stroke, taking medications that may affect endpoint analyses, have co-morbid contraindications to physical activity or dietary changes, or if the participant is currently pregnant or planning to become pregnant in the next year.

研究组 & 干预措施

Single arm pre/post study

Experimental

干预措施: Family Diabetes Prevention (Behavioral)

结局指标

主要结局

Weight Reduction

时间窗: From enrollment to the end of intervention at 6 months

Weight at 12 weeks (post intervention) and three month follow up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rakale Collins Quarells

Principal Investigator

Morehouse School of Medicine

研究点 (1)

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Georgia CEAL RESTORES Family Diabetes Study | 临床试验