Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Percent Change in Weight
研究概览
简要总结
The specific objective of this research proposal is to determine the short-term efficacy of a primary care-based weight control intervention in which successful volunteer peers deliver a group-based program.
The purpose of the study is to conduct a pilot randomized controlled trial (RCT) of a successful volunteer peer-led weight control program compared to a control condition to determine intervention efficacy at 3 months. Six peer leaders from 2 primary care clinics will be recruited and trained to conduct the intervention. Overweight and obese patients (n=80) will be recruited (randomized by individual) to determine weight loss at 3 months (primary outcome). The program consists of 12 weekly weight loss sessions led by a successful volunteer peer leader using an adaptation of the Diabetes Prevention Program to help participants lose weight.
详细描述
The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. The initial weight loss session will be conducted by the peer leaders with oversight by the PI. This session will serve to introduce the program and give an overview of program. The remaining sessions, conducted by co-peer leaders, will utilize an adaptation of the Diabetes Prevention Program. This adaptation allows for use in a group setting and facilitation by a lay individual.
Control Condition: Participants in the control condition will be given written information at the baseline visit from the NIH website "Aim for a Healthy Weight" to provide a basic understanding of weight loss and access to basic online resources. We expect that use of the website may result in some weight loss. However, similar information-only interventions have had a very small effect, which is accounted for in the sample size calculation.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Successful at volitional weight loss, defined as at least 10% of their initial body weight and maintenance for ≥ 1 year
- •Fluently speak and read English
- •Willing to volunteer 1 hour each week as a group leader
- •Able and willing to give informed consent.
- •Must have internet access
- •Participant Inclusion Criteria:
- •Fluently speak and read English
- •Able and willing to give informed consent
- •Body Mass Index > 25 and < 45
- •Interested in participating in weekly group sessions for weight loss
- •Must have internet access
排除标准
- •Current or planned pregnancy within the next year
- •Medical or other contraindications to weight loss, including, but not limited to, history of:
- •Myocardial infarction
- •Unstable angina
- •Congestive heart failure
- •Cancer (except non-melanoma skin cancer)
- •History of gastric bypass surgery or scheduled surgery for this purpose
- •Current use of prescription medication for weight loss
- •Weight loss of > 5% of current body weight in previous 6 months
- •Contraindications to weight loss
- •Evidence of severe cognitive impairment or major psychiatric illness
- •Plans to move in the next 6 months
- •Answering yes to any question on the Physical Activity Readiness Questionnaire (PAR-Q)
结局指标
主要结局
Percent Change in Weight
时间窗: 12 weeks after initial consent
We will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.
次要结局
- Physical Activity(12 weeks after initial consent)
- BMI(12 weeks after initial consent)
- Blood Pressure(12 weeks after initial consent)
- Dietary Intake(12 weeks after initial consent)
研究者
Jennifer Kraschnewski
Assistant Professor of Medicine
Milton S. Hershey Medical Center