Satiating Diet vs. Restrictive Intervention for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
The objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in appetite and attenuate body weight regain usually observed after weight loss in men and women living with obesity. This is an 18-month, randomized, controlled, parallel weight loss \[Phase 1 (P1): 6 months\] and maintenance trial \[Phase 2 (P2): 12 months\] with three groups (n=234 men and women): (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). All groups will be controlled for physical activity and sleep patterns. The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). Measurements at baseline (week 0), after P1 and P2 will include the following primary outcomes: appetite control, weight loss and maintenance; and secondary outcomes: body composition, physiological, psycho and neurobehavioural and health-related variables. Follow-ups will be done by a dietitian every 2 weeks during P1 and once a month during P2.
Will I have to stop taking my current medications?
If you are taking medications that could affect your appetite or body weight, such as thyroid replacement therapy, sulfonylureas, or glucocorticoids, you will not be eligible to participate in this trial.
Is the Satiating Diet vs. Restrictive Intervention for Obesity safe for humans?
How does the non-restrictive satiating diet treatment for obesity differ from other treatments?
The non-restrictive satiating diet is unique because it allows individuals to eat freely without strict calorie limits, focusing on a balance of higher protein and fat intake to enhance feelings of fullness, which may lead to better adherence and weight loss compared to traditional restrictive diets.678910
What data supports the effectiveness of the treatment Satiating Diet vs. Restrictive Intervention for Obesity?
Research shows that a non-restrictive satiating diet can lead to significant weight loss and improved eating behaviors in obese individuals, with lower dropout rates compared to a control diet. Additionally, personalized dietary strategies that focus on behavior change and energy intake reduction are effective for sustainable weight management.7891112
Are You a Good Fit for This Trial?
This trial is for men and women aged 18-50 with obesity, defined by a waist circumference over 102 cm for men or over 88 cm for women, and a BMI between 30 and <40. Participants should not be on medications affecting weight or appetite, have chronic diseases, use excessive alcohol or caffeine, or be pregnant. They also shouldn't engage in high physical activity.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Weight Loss Phase
Participants undergo a 6-month weight loss intervention with different strategies: non-restrictive satiating intervention, conventional restrictive intervention, or minimal healthy guidelines.
Maintenance Phase
Participants continue with a 12-month weight maintenance intervention, either continuing the non-restrictive satiating intervention or switching from a restrictive intervention.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Control group
- Conventional restrictive intervention + non-restrictive satiating intervention
- Non-restrictive satiating intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laval University
Lead Sponsor
University of Ottawa
Collaborator