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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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:
- 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.
- Conditions
- Obesity, Risk Factors
- 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 group | Role | What they receive |
|---|---|---|
| Motivational interviewing | Experimental | Not described Receives: Behavioral: Motivational interviewing |
| no motivational interviewing | Active comparator | Not described Receives: Behavioral: Educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Retention Rate
% of participants who complete 6-month follow-up
Measured: from 0 to 6 months
Data Completion
Number of participants with no missing data on clinical outcomes
Measured: At 6 months
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:
- = Highly Dissatisfied
- = Dissatisfied
- = Neither Satisfied nor Dissatisfied
- = Satisfied
- = Highly Satisfied Mean scores were calculated, with higher scores indicating greater satisfaction.
Measured: At 6 months
Secondary outcomes (5)
Body Mass Index (BMI) Change
Change in BMI from baseline to 6-month follow-up
Measured: Change from 0 to 6 months
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
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
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
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.
- First posted3 Mar 2022
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Laura N Anderson, PhD, Principal investigator, McMaster UniversityLawrence Mbuagbaw, MD, PhD, Principal investigator, McMaster University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Promote Healthy Behaviours for Obesity Prevention in Young Adults: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05264740
- Acronym / sponsor ID
- Motivate / 707228
- Conditions
- Obesity, Risk Factors
- Keywords
- prevention, young adult, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), St. Joseph's Healthcare Hamilton
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Experimental | Behavioral: Motivational interviewing |
| no motivational interviewing | Active comparator | Behavioral: Educational materials |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English speaking, and capable of providing informed consent
- McMaster University students 18-29 years of age
- Body mass index of at least 18.5
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingThe intervention group will receive motivational interviewing sessions with a trained study nurse plus educational material | Behavioural | Motivational interviewing |
| Educational materialsThe control group will receive educational material only. | Behavioural | no motivational interviewing |
Primary outcome
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
Retention Rate
Time frame: from 0 to 6 months
% of participants who complete 6-month follow-up
Data Completion
Time frame: At 6 months
Number of participants with no missing data on clinical outcomes
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: 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.
5 secondary outcomes
Body Mass Index (BMI) Change
Time frame: Change from 0 to 6 months
Physical Activity
Time frame: At 6 months
Sedentary Time
Time frame: At 6 months
Nutrition
Time frame: At 6 months
Mental Health
Time frame: At 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37679845Anderson 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.
- Individual participant dataSharing planned: No. For this pilot study, individual data will not be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura N Anderson, PhD principal investigator
McMaster University
Lawrence Mbuagbaw, MD, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
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.