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ObesityMotivateNCT05264740

Motivational Interviewing to Promote Healthy Behaviours in Young Adults

A study testing Motivational interviewing and Educational materials in people with Obesity and Risk Factors, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Risk Factors
What is being tested?
Motivational interviewing and Educational materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteCanada
Study dates
1 Feb 2023to 1 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McMaster University

    Hamilton, Ontario, L8S4L8

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Motivational interviewing, Educational materials
Keywords
prevention, young adult, exercise
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational interviewingBehavioural

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

  • Educational materialsBehavioural

    The control group will receive educational material only.

Study groups in NCT05264740
Study groupRoleWhat they receive
Motivational interviewingExperimentalNot described
Receives: Behavioral: Motivational interviewing
no motivational interviewingActive comparatorNot described
Receives: Behavioral: Educational materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

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

    Measured: At recruitment, over 6 months.

  2. Retention Rate

    % of participants who complete 6-month follow-up

    Measured: from 0 to 6 months

  3. Data Completion

    Number of participants with no missing data on clinical outcomes

    Measured: At 6 months

  4. Study Satisfaction

    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.

    Measured: At 6 months

Secondary outcomes (5)
  1. Body Mass Index (BMI) Change

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

    Measured: Change from 0 to 6 months

  2. Physical Activity

    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.

    Measured: At 6 months

  3. Sedentary Time

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

    Measured: At 6 months

  4. Nutrition

    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, %).

    Measured: At 6 months

  5. Mental Health

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

    Measured: At 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start1 Feb 2023
  3. Primary completion1 Feb 2024
  4. Study completion1 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05264740
Sponsor's protocol ID
707228
Acronym
Motivate
Status last verified
Feb 2025
First submitted
22 Feb 2022
Last updated
18 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: For this pilot study, individual data will not be available.

Publications

  • Anderson LN, Alvarez E, Incze T, Tarride JE, Kwan M, Mbuagbaw L. Motivational interviewing to promote healthy behaviors for obesity prevention in young adults (MOTIVATE): a pilot randomized controlled trial protocol. Pilot Feasibility Stud. 2023 Sep 7;9(1):156. doi: 10.1186/s40814-023-01385-0.

    PubMed 37679845

Questions about this trial

What is this clinical trial studying?

A study testing Motivational interviewing and Educational materials in people with Obesity and Risk Factors, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: At recruitment, over 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05264740, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.

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