Motivational Interviewing to Promote Healthy Behaviours in Young Adults (Motivate)
Primary Purpose
Obesity, Risk Factors
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Motivational interviewing
Educational materials
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring prevention, young adult, exercise
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
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motivational interviewing
no motivational interviewing
Arm Description
Outcomes
Primary Outcome Measures
Recruitment rate
% of eligible participants who are recruited from all those who contact the research team to learn about the study
Retention rate
% of participants who complete 6-month follow-up
Data completion
% of clinical outcomes with no missing data
Satisfaction
Mean score on a 7-point Likert scale (from 1 to 7, where 7 is high satisfaction)
Secondary Outcome Measures
Body mass index (BMI) change
Change in BMI from baseline to 6-month follow-up
Physical activity
Minutes per day from activity trackers and questionnaire
Sedentary time
Measured per day from activity trackers and questionnaire
Nutrition
Measured from National Cancer Institute's Dietary Screener Questionnaire
Mental health
Including depressive and anxiety symptoms and self-reported quality of life
Full Information
NCT ID
NCT05264740
First Posted
February 22, 2022
Last Updated
June 7, 2023
Sponsor
McMaster University
Collaborators
Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT05264740
Brief Title
Motivational Interviewing to Promote Healthy Behaviours in Young Adults
Acronym
Motivate
Official Title
Motivational Interviewing to Promote Healthy Behaviours for Obesity Prevention in Young Adults: a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), St. Joseph's Healthcare Hamilton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Risk Factors
Keywords
prevention, young adult, exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motivational interviewing
Arm Type
Experimental
Arm Title
no motivational interviewing
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
The intervention group will receive motivational interviewing sessions with a trained study nurse plus educational material
Intervention Type
Behavioral
Intervention Name(s)
Educational materials
Intervention Description
The control group will receive educational material only.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
% of eligible participants who are recruited from all those who contact the research team to learn about the study
Time Frame
At recruitment
Title
Retention rate
Description
% of participants who complete 6-month follow-up
Time Frame
from 0 to 6 months
Title
Data completion
Description
% of clinical outcomes with no missing data
Time Frame
At 6 months
Title
Satisfaction
Description
Mean score on a 7-point Likert scale (from 1 to 7, where 7 is high satisfaction)
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Body mass index (BMI) change
Description
Change in BMI from baseline to 6-month follow-up
Time Frame
Change from 0 to 6 months
Title
Physical activity
Description
Minutes per day from activity trackers and questionnaire
Time Frame
At 6 months
Title
Sedentary time
Description
Measured per day from activity trackers and questionnaire
Time Frame
At 6 months
Title
Nutrition
Description
Measured from National Cancer Institute's Dietary Screener Questionnaire
Time Frame
At 6 months
Title
Mental health
Description
Including depressive and anxiety symptoms and self-reported quality of life
Time Frame
At 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura N Anderson, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Mbuagbaw, MD, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4L8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
For this pilot study, individual data will not be available.
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Motivational Interviewing to Promote Healthy Behaviours in Young Adults
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