Clinical trial NCT05264740: Motivational Interviewing to Promote Healthy Behaviours in Young Adults
Official title: Motivational Interviewing to Promote Healthy Behaviours for Obesity Prevention in Young Adults: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Risk Factors
Keywords: prevention
young adult
exercise
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: Canadian Institutes of Health Research (CIHR)
name: St. Joseph's Healthcare Hamilton
First posted: 2022-03-03
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Our proposed evaluation of the feasibility of an obesity prevention intervention in early adulthood will inform future larger RCTs for obesity prevention. The results of this study have the potential to directly contribute to the primary prevention of several types of cancer by testing an intervention that could be scalable to public health, post-secondary education, or primary care settings.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: At recruitment, over 6 months.
measure: Retention Rate
timeFrame: from 0 to 6 months
measure: Data Completion
timeFrame: At 6 months
measure: Study Satisfaction
timeFrame: At 6 months
Secondary outcomes:
measure: Body Mass Index (BMI) Change
timeFrame: Change from 0 to 6 months
measure: Physical Activity
timeFrame: At 6 months
measure: Sedentary Time
timeFrame: At 6 months
measure: Nutrition
timeFrame: At 6 months
measure: Mental Health
timeFrame: At 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Laura N Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Lawrence Mbuagbaw, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: