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Motivational Interviewing to Promote Healthy Behaviours in Young Adults

Motivational Interviewing to Promote Healthy Behaviours for Obesity Prevention in Young Adults: a Pilot Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05264740
Acronym
Motivate
Enrollment
101
Registered
2022-03-03
Start date
2023-02-01
Completion date
2024-02-01
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Risk Factors

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

BEHAVIORALMotivational interviewing

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

BEHAVIORALEducational materials

The control group will receive educational material only.

Sponsors

Canadian Cancer Society (CCS)
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
St. Joseph's Healthcare Hamilton
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Recruitment RateAt recruitment, over 6 months.% of eligible participants who are recruited from all those who contact the research team to learn about the study
Retention Ratefrom 0 to 6 months% of participants who complete 6-month follow-up
Data CompletionAt 6 monthsNumber of participants with no missing data on clinical outcomes
Study SatisfactionAt 6 monthsSatisfaction 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

MeasureTime frameDescription
Body Mass Index (BMI) ChangeChange from 0 to 6 monthsChange in BMI from baseline to 6-month follow-up
Mental HealthAt 6 monthsDepressive Symptoms- defined by the Center for Epidemiologic Studies Depression Scale (CES-D). \>=10 indicating presence of depressive symptoms, \<10 no depressive symptoms.
Physical ActivityAt 6 monthsMinutes 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 TimeAt 6 monthsMeasured per day from activity trackers and questionnaire. Sedentary behaviour was assessed using the International Sedentary Assessment Tool (ISAT).
NutritionAt 6 monthsMeasured 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

ArmCount
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
Total100

Withdrawals & dropouts

PeriodReasonFG000FG001
BaselineWithdrawal by Subject01
Follow Up 1Lost to Follow-up11
Follow Up 1Withdrawal by Subject01
Follow Up 2Lost to Follow-up14
Follow Up 3Lost to Follow-up74

Baseline characteristics

CharacteristicMotivational Interviewingno Motivational InterviewingTotal
Age, Continuous21.8 years
STANDARD_DEVIATION 3.49
23 years
STANDARD_DEVIATION 3.61
22.2 years
STANDARD_DEVIATION 3.56
Body Mass Index24.6 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 Participants0 Participants5 Participants
Race/Ethnicity, Customized
East Asian
10 Participants9 Participants19 Participants
Race/Ethnicity, Customized
Latino
1 Participants2 Participants3 Participants
Race/Ethnicity, Customized
Middle Eastern
10 Participants17 Participants27 Participants
Race/Ethnicity, Customized
Other
0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
South Asian
18 Participants12 Participants30 Participants
Race/Ethnicity, Customized
Southeast Asian
0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
White
6 Participants5 Participants11 Participants
Sex: Female, Male
Female
24 Participants22 Participants46 Participants
Sex: Female, Male
Male
28 Participants26 Participants54 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 49
other
Total, other adverse events
0 / 520 / 49
serious
Total, serious adverse events
0 / 520 / 49

Outcome results

Primary

Data Completion

Number of participants with no missing data on clinical outcomes

Time frame: At 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
RecruitmentData Completion48 Participants
no Motivational InterviewingData Completion45 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
RecruitmentRecruitment Rate101 Participants
Primary

Retention Rate

% of participants who complete 6-month follow-up

Time frame: from 0 to 6 months

ArmMeasureValue (NUMBER)
RecruitmentRetention Rate43 participants
no Motivational InterviewingRetention Rate38 participants
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: 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.

ArmMeasureValue (MEAN)Dispersion
RecruitmentStudy Satisfaction3.8 units on a scaleStandard Deviation 1.02
no Motivational InterviewingStudy Satisfaction3.9 units on a scaleStandard Deviation 1.05
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
RecruitmentBody Mass Index (BMI) Change-0.3 kg/m²Standard Deviation 0.89
no Motivational InterviewingBody Mass Index (BMI) Change-0.5 kg/m²Standard Deviation 1.52
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.

Time frame: At 6 months

Population: Discrepancy in number analyzed due to missing data.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
RecruitmentMental HealthYes (>=10)23 Participants
RecruitmentMental HealthNo (<10)21 Participants
no Motivational InterviewingMental HealthYes (>=10)20 Participants
no Motivational InterviewingMental HealthNo (<10)19 Participants
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, %).

Time frame: At 6 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
RecruitmentNutrition<1 time per week6 Participants
RecruitmentNutrition1-5 times/week25 Participants
RecruitmentNutrition≥1 time/day12 Participants
no Motivational InterviewingNutrition<1 time per week7 Participants
no Motivational InterviewingNutrition1-5 times/week20 Participants
no Motivational InterviewingNutrition≥1 time/day10 Participants
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.

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
RecruitmentPhysical ActivityVigorous activity (0 days)14 Participants
RecruitmentPhysical ActivityVigorous activity (1-3 days)19 Participants
RecruitmentPhysical ActivityVigorous activity (4-6 days)11 Participants
RecruitmentPhysical ActivityVigorous activity (7 days)0 Participants
no Motivational InterviewingPhysical ActivityVigorous activity (7 days)0 Participants
no Motivational InterviewingPhysical ActivityVigorous activity (0 days)12 Participants
no Motivational InterviewingPhysical ActivityVigorous activity (4-6 days)6 Participants
no Motivational InterviewingPhysical ActivityVigorous activity (1-3 days)19 Participants
Secondary

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.

ArmMeasureGroupValue (MEDIAN)
RecruitmentSedentary TimeSitting (pastime) (hrs)5 hours
RecruitmentSedentary TimeDriving (hrs)1 hours
RecruitmentSedentary TimeSitting (full day) (hrs)7.9 hours
no Motivational InterviewingSedentary TimeSitting (pastime) (hrs)4 hours
no Motivational InterviewingSedentary TimeDriving (hrs)1 hours
no Motivational InterviewingSedentary TimeSitting (full day) (hrs)8 hours

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026