Motivate: Motivational Interviewing to Promote Healthy Behaviours in Young Adults

Sponsor
McMaster University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05264740
Collaborator
Canadian Cancer Society (CCS) (Other), Canadian Institutes of Health Research (CIHR) (Other), St. Joseph's Healthcare Hamilton (Other)
110
2
19

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational interviewing
  • Behavioral: Educational materials
N/A

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:
  1. 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)

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Motivational Interviewing to Promote Healthy Behaviours for Obesity Prevention in Young Adults: a Pilot Randomized Controlled Trial
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Motivational interviewing

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

Active Comparator: no motivational interviewing

Behavioral: Educational materials
The control group will receive educational material only.

Outcome Measures

Primary Outcome Measures

  1. Recruitment rate [At recruitment]

    % of eligible participants who are recruited from all those who contact the research team to learn about the study

  2. Retention rate [from 0 to 6 months]

    % of participants who complete 6-month follow-up

  3. Data completion [At 6 months]

    % of clinical outcomes with no missing data

  4. Satisfaction [At 6 months]

    Mean score on a 7-point Likert scale (from 1 to 7, where 7 is high satisfaction)

Secondary Outcome Measures

  1. Body mass index (BMI) change [Change from 0 to 6 months]

    Change in BMI from baseline to 6-month follow-up

  2. Physical activity [At 6 months]

    Minutes per day from activity trackers and questionnaire

  3. Sedentary time [At 6 months]

    Measured per day from activity trackers and questionnaire

  4. Nutrition [At 6 months]

    Measured from National Cancer Institute's Dietary Screener Questionnaire

  5. Mental health [At 6 months]

    Including depressive and anxiety symptoms and self-reported quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 29 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Laura N Anderson, PhD, McMaster University
  • Principal Investigator: Lawrence Mbuagbaw, MD, PhD, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
McMaster University
ClinicalTrials.gov Identifier:
NCT05264740
Other Study ID Numbers:
  • 707228
First Posted:
Mar 3, 2022
Last Update Posted:
Mar 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by McMaster University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2022