NCT05264740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 18, 2025

Completed
Last Updated

May 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 22, 2022

Results QC Date

February 27, 2025

Last Update Submit

May 1, 2025

Conditions

Keywords

preventionyoung adultexercise

Outcome Measures

Primary Outcomes (4)

  • Recruitment Rate

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

    At recruitment, over 6 months.

  • Retention Rate

    % of participants who complete 6-month follow-up

    from 0 to 6 months

  • Data Completion

    Number of participants with no missing data on clinical outcomes

    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: 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.

    At 6 months

Secondary Outcomes (5)

  • 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

Study Arms (2)

Motivational interviewing

EXPERIMENTAL
Behavioral: Motivational interviewing

no motivational interviewing

ACTIVE COMPARATOR
Behavioral: Educational materials

Interventions

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

Motivational interviewing

The control group will receive educational material only.

no motivational interviewing

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4L8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Laura Anderson
Organization
McMaster University

Study Officials

  • Laura N Anderson, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR
  • Lawrence Mbuagbaw, MD, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 3, 2022

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

May 18, 2025

Results First Posted

May 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

For this pilot study, individual data will not be available.

Locations