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Completed

NCT Number: NCT05264740

Motivational Interviewing to Promote Healthy Behaviours in Young Adults

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.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S4L8, Canada

About this study

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:

  • 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:

  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

The intervention group will receive motivational interviewing sessions with a trained study nurse plus educational material

Educational materials

Behavioral

The control group will receive educational material only.

Primary outcomes

  1. Recruitment Rate

    Time frame: At recruitment, over 6 months.

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

  2. Retention Rate

    Time frame: from 0 to 6 months

    % of participants who complete 6-month follow-up

  3. Data Completion

    Time frame: At 6 months

    Number of participants with no missing data on clinical outcomes

  4. Study Satisfaction

    Time frame: 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:

    • = Highly Dissatisfied
    • = Dissatisfied
    • = Neither Satisfied nor Dissatisfied
    • = Satisfied
    • = Highly Satisfied Mean scores were calculated, with higher scores indicating greater satisfaction.

Secondary outcomes

  1. Body Mass Index (BMI) Change

    Time frame: Change from 0 to 6 months

    Change in BMI from baseline to 6-month follow-up

  2. Physical Activity

    Time frame: At 6 months

    Minutes per day from activity trackers and International Physical Activity Questionnaire (IPAQ).Participants self-reported the number of days per week they engaged in moderate and vigorous physical activity using items adapted from the International Physical Activity Questionnaire (IPAQ). Responses ranged from 0 to 7 days per week for each activity type.

  3. Sedentary Time

    Time frame: At 6 months

    Measured per day from activity trackers and questionnaire. Sedentary behaviour was assessed using the International Sedentary Assessment Tool (ISAT).

  4. Nutrition

    Time frame: At 6 months

    Measured from National Cancer Institute's Dietary Screener Questionnaire. Items from the National Cancer Institute's Dietary Screener Questionnaire (DSQ), which asked participants how often they consumed fruit over the past month. Responses ranged from "Never" to "More than once a day" and were reported separately for each item as frequency categories (n, %).

  5. Mental Health

    Time frame: At 6 months

    Depressive Symptoms- defined by the Center for Epidemiologic Studies Depression Scale (CES-D). >=10 indicating presence of depressive symptoms, <10 no depressive symptoms.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Cancer Society (CCS)
  • Canadian Institutes of Health Research (CIHR)
  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

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

Acronym: Motivate

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2022
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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