Obesity, Risk Factors
Conditions
Keywords
prevention, young adult, exercise
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: 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.
Interventions
The intervention group will receive motivational interviewing sessions with a trained study nurse plus educational material
The control group will receive educational material only.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 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 | from 0 to 6 months | % of participants who complete 6-month follow-up |
| Data Completion | At 6 months | Number of participants with no missing data on clinical outcomes |
| Study Satisfaction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) Change | Change from 0 to 6 months | Change in BMI from baseline to 6-month follow-up |
| Mental Health | At 6 months | Depressive Symptoms- defined by the Center for Epidemiologic Studies Depression Scale (CES-D). \>=10 indicating presence of depressive symptoms, \<10 no depressive symptoms. |
| Physical Activity | At 6 months | 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. |
| Sedentary Time | At 6 months | Measured per day from activity trackers and questionnaire. Sedentary behaviour was assessed using the International Sedentary Assessment Tool (ISAT). |
| Nutrition | At 6 months | 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, %). |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivational Interviewing Motivational interviewing: The intervention group will receive motivational interviewing sessions with a trained study team member plus educational material | 52 |
| no Motivational Interviewing Educational materials: The control group will receive educational material only. | 48 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline | Withdrawal by Subject | 0 | 1 |
| Follow Up 1 | Lost to Follow-up | 1 | 1 |
| Follow Up 1 | Withdrawal by Subject | 0 | 1 |
| Follow Up 2 | Lost to Follow-up | 1 | 4 |
| Follow Up 3 | Lost to Follow-up | 7 | 4 |
Baseline characteristics
| Characteristic | Motivational Interviewing | no Motivational Interviewing | Total |
|---|---|---|---|
| Age, Continuous | 21.8 years STANDARD_DEVIATION 3.49 | 23 years STANDARD_DEVIATION 3.61 | 22.2 years STANDARD_DEVIATION 3.56 |
| Body Mass Index | 24.6 kg/m² STANDARD_DEVIATION 4.43 | 25.6 kg/m² STANDARD_DEVIATION 5.27 | 25.1 kg/m² STANDARD_DEVIATION 4.85 |
| Race/Ethnicity, Customized Black | 5 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized East Asian | 10 Participants | 9 Participants | 19 Participants |
| Race/Ethnicity, Customized Latino | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Middle Eastern | 10 Participants | 17 Participants | 27 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized South Asian | 18 Participants | 12 Participants | 30 Participants |
| Race/Ethnicity, Customized Southeast Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Female | 24 Participants | 22 Participants | 46 Participants |
| Sex: Female, Male Male | 28 Participants | 26 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 49 |
| other Total, other adverse events | 0 / 52 | 0 / 49 |
| serious Total, serious adverse events | 0 / 52 | 0 / 49 |
Outcome results
Data Completion
Number of participants with no missing data on clinical outcomes
Time frame: At 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruitment | Data Completion | 48 Participants |
| no Motivational Interviewing | Data Completion | 45 Participants |
Recruitment Rate
% of eligible participants who are recruited from all those who contact the research team to learn about the study
Time frame: At recruitment, over 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruitment | Recruitment Rate | 101 Participants |
Retention Rate
% of participants who complete 6-month follow-up
Time frame: from 0 to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Recruitment | Retention Rate | 43 participants |
| no Motivational Interviewing | Retention Rate | 38 participants |
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.
Time frame: At 6 months
Population: All participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recruitment | Study Satisfaction | 3.8 units on a scale | Standard Deviation 1.02 |
| no Motivational Interviewing | Study Satisfaction | 3.9 units on a scale | Standard Deviation 1.05 |
Body Mass Index (BMI) Change
Change in BMI from baseline to 6-month follow-up
Time frame: Change from 0 to 6 months
Population: Discrepancy in Overall Number Analyzed due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recruitment | Body Mass Index (BMI) Change | -0.3 kg/m² | Standard Deviation 0.89 |
| no Motivational Interviewing | Body Mass Index (BMI) Change | -0.5 kg/m² | Standard Deviation 1.52 |
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.
Time frame: At 6 months
Population: Discrepancy in number analyzed due to missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Recruitment | Mental Health | Yes (>=10) | 23 Participants |
| Recruitment | Mental Health | No (<10) | 21 Participants |
| no Motivational Interviewing | Mental Health | Yes (>=10) | 20 Participants |
| no Motivational Interviewing | Mental Health | No (<10) | 19 Participants |
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, %).
Time frame: At 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Recruitment | Nutrition | <1 time per week | 6 Participants |
| Recruitment | Nutrition | 1-5 times/week | 25 Participants |
| Recruitment | Nutrition | ≥1 time/day | 12 Participants |
| no Motivational Interviewing | Nutrition | <1 time per week | 7 Participants |
| no Motivational Interviewing | Nutrition | 1-5 times/week | 20 Participants |
| no Motivational Interviewing | Nutrition | ≥1 time/day | 10 Participants |
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.
Time frame: At 6 months
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Recruitment | Physical Activity | Vigorous activity (0 days) | 14 Participants |
| Recruitment | Physical Activity | Vigorous activity (1-3 days) | 19 Participants |
| Recruitment | Physical Activity | Vigorous activity (4-6 days) | 11 Participants |
| Recruitment | Physical Activity | Vigorous activity (7 days) | 0 Participants |
| no Motivational Interviewing | Physical Activity | Vigorous activity (7 days) | 0 Participants |
| no Motivational Interviewing | Physical Activity | Vigorous activity (0 days) | 12 Participants |
| no Motivational Interviewing | Physical Activity | Vigorous activity (4-6 days) | 6 Participants |
| no Motivational Interviewing | Physical Activity | Vigorous activity (1-3 days) | 19 Participants |
Sedentary Time
Measured per day from activity trackers and questionnaire. Sedentary behaviour was assessed using the International Sedentary Assessment Tool (ISAT).
Time frame: At 6 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Recruitment | Sedentary Time | Sitting (pastime) (hrs) | 5 hours |
| Recruitment | Sedentary Time | Driving (hrs) | 1 hours |
| Recruitment | Sedentary Time | Sitting (full day) (hrs) | 7.9 hours |
| no Motivational Interviewing | Sedentary Time | Sitting (pastime) (hrs) | 4 hours |
| no Motivational Interviewing | Sedentary Time | Driving (hrs) | 1 hours |
| no Motivational Interviewing | Sedentary Time | Sitting (full day) (hrs) | 8 hours |