Motivational Interviewing to Promote Healthy Behaviours in Young Adults

Obesity Clinical Trial

— Motivate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264740
• Other study ID #: 707228
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

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

Related Conditions & MeSH terms

• Obesity
• Risk Factors

Intervention

Behavioral:
• Motivational interviewing
The intervention group will receive motivational interviewing sessions with a trained study nurse plus educational material
• Educational materials
The control group will receive educational material only.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	% of eligible participants who are recruited from all those who contact the research team to learn about the study	At recruitment
Primary	Retention rate	% of participants who complete 6-month follow-up	from 0 to 6 months
Primary	Data completion	% of clinical outcomes with no missing data	At 6 months
Primary	Satisfaction	Mean score on a 7-point Likert scale (from 1 to 7, where 7 is high satisfaction)	At 6 months
Secondary	Body mass index (BMI) change	Change in BMI from baseline to 6-month follow-up	Change from 0 to 6 months
Secondary	Physical activity	Minutes per day from activity trackers and questionnaire	At 6 months
Secondary	Sedentary time	Measured per day from activity trackers and questionnaire	At 6 months
Secondary	Nutrition	Measured from National Cancer Institute's Dietary Screener Questionnaire	At 6 months
Secondary	Mental health	Including depressive and anxiety symptoms and self-reported quality of life	At 6 months