跳至主要内容
临床试验/NCT05264740
NCT05264740已完成不适用

Motivational Interviewing to Promote Healthy Behaviours for Obesity Prevention in Young Adults: a Pilot Randomized Controlled Trial

McMaster University2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
Recruitment Rate

研究概览

简要总结

The overall goals of this project are to evaluate the feasibility of web-based nurse-led motivational interviewing and educational interventions to promote healthy behaviours for obesity prevention and maintenance of healthy weight and behaviours among young adults attending university (age 18-29) in Hamilton, Ontario. A secondary goal is to evaluate if the intervention is more successful among people at higher risk of obesity (a risk stratification approach). A pilot randomized controlled trial will be conducted. Young adults will be randomized to receive a tailored behavioural intervention through motivational interviewing sessions with a nurse combined with educational materials, or control (educational materials only). Both groups will be followed for 6 months and their weight at baseline and end of the study will be measured. Outcomes related to the feasibility of the intervention and participants' experiences in the study will also be measured.

详细描述

Obesity is an established risk factor for many cancer types, including colon, endometrial, breast, and pancreatic. Obesity is complex and treatment is challenging. Thus, primary prevention of obesity is important. This is particularly important now since the COVID-19 pandemic had a profound impact on many obesity risk factors, such as chronic stress, overeating, and physical inactivity. Early adulthood is a key period in obesity development and a critical period for prevention interventions. Young adulthood is a period when Canadians may be highly amenable to healthy behaviour change, develop lifelong healthy behaviours and the primary prevention of obesity may be feasible. Interventions in early adulthood have the potential for primordial cancer prevention (i.e., stopping cancer risk factors before they develop). Despite the known impact of obesity on cancer, there have been few attempts to implement tailored population-based obesity prevention interventions. Obesity interventions must be flexible to address the complex causes of obesity and motivational interviewing may be a successful strategy.

Primary Objective:

  1. To determine the feasibility (enrollment, retention, data completion, satisfaction) of a 6-month behavioural and educational intervention to promote healthy behaviours for obesity prevention among young adults.

Secondary objectives: 2. To determine the effects of the 6-month behavioural and educational intervention, compared to an educational intervention only, on change in BMI, health behaviours (nutrition, physical activity and sedentary time) and mental health (depression and anxiety) 3. To explore whether obesity risk stratification tools identify young adults who may be more successful in an obesity intervention.

Methods: A pilot randomized controlled trial will be conducted. Young adults (age 18-29) attending McMaster University will be recruited and randomized to either the intervention or control. The intervention will include individual motivational interviewing sessions (online or in-person) with a trained public health nurse plus educational materials (based on Canada's food guide and physical activity recommendations). The control group will receive educational materials only. The primary feasibility outcomes that will be evaluated as part of this pilot study include enrollment, retention (≥80%), data completion (≥80% of weights measured, and surveys completed), and participant satisfaction. Clinical outcomes will include weight change from baseline to 6-months, physical activity, nutrition risk, and mental health. Outcomes will be measured remotely using 'smart' electronic scales, activity trackers, and online questionnaires at baseline and every 2 months. Risk stratification will be applied at baseline to identify participants at high risk of obesity (e.g., due to family or personal history). Exit questionnaires will collect data on how participants felt about the study and cost analysis will be conducted.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking, and capable of providing informed consent
  • McMaster University students 18-29 years of age
  • Body mass index of at least 18.5

排除标准

  • Physical and mental health conditions that would be contraindicated for a weight management intervention, including eating disorders, pregnancy, cancer, or medications that affect body weight

结局指标

主要结局

Recruitment Rate

时间窗: At recruitment, over 6 months.

% of eligible participants who are recruited from all those who contact the research team to learn about the study

Retention Rate

时间窗: from 0 to 6 months

% of participants who complete 6-month follow-up

Data Completion

时间窗: At 6 months

Number of participants with no missing data on clinical outcomes

Study Satisfaction

时间窗: At 6 months

Satisfaction was measured using a single-item question: "How satisfied are you with this research study?" Responses were collected on a 5-point Likert scale with the following options: 1. = Highly Dissatisfied 2. = Dissatisfied 3. = Neither Satisfied nor Dissatisfied 4. = Satisfied 5. = Highly Satisfied Mean scores were calculated, with higher scores indicating greater satisfaction.

次要结局

  • Body Mass Index (BMI) Change(Change from 0 to 6 months)
  • Physical Activity(At 6 months)
  • Sedentary Time(At 6 months)
  • Nutrition(At 6 months)
  • Mental Health(At 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Motivational Interviewing to Promote Healthy... | 临床试验