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| Name | Class |
|---|---|
| Canadian Cancer Society (CCS) | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| St. Joseph's Healthcare Hamilton | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational interviewing | Experimental |
| |
| no motivational interviewing | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interviewing | Behavioral | The intervention group will receive motivational interviewing sessions with a trained study nurse plus educational material |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) Change | Change in BMI from baseline to 6-month follow-up | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura N Anderson, PhD | McMaster University | Principal Investigator |
| Lawrence Mbuagbaw, MD, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8S4L8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37679845 | Derived | 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. |
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For this pilot study, individual data will not be available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interviewing | Motivational interviewing: The intervention group will receive motivational interviewing sessions with a trained study team member plus educational material |
| FG001 | no Motivational Interviewing | Educational materials: The control group will receive educational material only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Follow Up 1 |
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| Follow Up 2 |
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| Follow Up 3 |
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A total of 101 participants were randomized (52 to the Motivational Interviewing group, 49 to the No Motivational Interviewing group). One participant withdrew from the No Motivational Interviewing group before completing baseline characteristics, resulting in 100 participants. analyzed at baseline. For race/ethnicity participants were permitted to select "all that apply".
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interviewing | Motivational interviewing: The intervention group will receive motivational interviewing sessions with a trained study team member plus educational material |
| BG001 | no Motivational Interviewing |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Rate | % of eligible participants who are recruited from all those who contact the research team to learn about the study | Posted | Count of Participants | Participants | At recruitment, over 6 months. |
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6 months
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Interviewing | Motivational interviewing: The intervention group will receive motivational interviewing sessions with a trained study team member plus educational material |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Anderson | McMaster University | N/a | ln.anderson@mcmaster.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2022 | Apr 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Educational materials | Behavioral | The control group will receive educational material only. |
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| At 6 months |
| Sedentary Time | Measured per day from activity trackers and questionnaire. Sedentary behaviour was assessed using the International Sedentary Assessment Tool (ISAT). | 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, %). | 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. | At 6 months |
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Educational materials: The control group will receive educational material only.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m² |
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| Primary | Retention Rate | % of participants who complete 6-month follow-up | Posted | Number | participants | from 0 to 6 months |
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| Primary | Data Completion | Number of participants with no missing data on clinical outcomes | Posted | Count of Participants | Participants | At 6 months |
|
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| Primary | 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:
| All participants who completed the study. | Posted | Mean | Standard Deviation | units on a scale | At 6 months |
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| Secondary | Body Mass Index (BMI) Change | Change in BMI from baseline to 6-month follow-up | Discrepancy in Overall Number Analyzed due to missing data. | Posted | Mean | Standard Deviation | kg/m² | Change from 0 to 6 months |
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|
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| Secondary | 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. | Data from the IPAQ were available for 81 participants. Two participants in the control group had missing responses for the vigorous activity question, and two had missing responses for the moderate activity question. All participants in the intervention group completed both items. | Posted | Count of Participants | Participants | At 6 months |
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| Secondary | Sedentary Time | Measured per day from activity trackers and questionnaire. Sedentary behaviour was assessed using the International Sedentary Assessment Tool (ISAT). | Data on sedentary behavior were available for 82 participants. One participant in the control group did not complete the ISAT, while all participants in the intervention group provided complete data. | Posted | Median | Inter-Quartile Range | hours | At 6 months |
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| Secondary | 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, %). | Posted | Count of Participants | Participants | At 6 months |
|
|
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| Secondary | 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. | Discrepancy in number analyzed due to missing data. | Posted | Count of Participants | Participants | At 6 months |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | no Motivational Interviewing | Educational materials: The control group will receive educational material only. | 0 | 49 | 0 | 49 | 0 | 49 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Vigorous activity (4-6 days) |
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| Vigorous activity (7 days) |
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| Sitting (full day) (hrs) |
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| ≥1 time/day |
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