Satiating Diet, Appetite Control and Body Weight Loss in Individuals With Obesity
- Conditions
- Appetite ControlWeight MaintenanceWeight Loss
- Interventions
- Other: Non-restrictive satiating interventionOther: Conventional restrictive intervention + non-restrictive satiating interventionOther: Control group
- Registration Number
- NCT05141526
- Lead Sponsor
- Laval University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 234
- individuals with a BMI ≥30 and <40 kg/m2
- aged between 18-50 years
- waist circumference >102 cm in men and >88 cm in women.
- taking medications that could influence appetite or body weight (e.g. thyroid replacement therapy, sulfonylureas and glucocorticoids)
- being treated with insulin for type 2 diabetes
- large body weight fluctuations (>4 kg over last two months)
- characterized by high restraint behaviour (score >12, measured with the TFEQ)
- history of an eating disorder (e.g. binge eating disorder) using the EDE questionnaire
- performing >150 min of moderate-vigorous intensity physical activity/week
- use of nutritional supplements (multivitamins, calcium, protein, fibre); 8) smoking, drugs or alcohol (>2 drinks/d)
- consumption of >5 cups of coffee/d
- (pre)menopausal or pregnant women
- diagnosis of chronic diseases, acute infections or gastric problems (e.g. ulcers)
- food allergies/intolerances to ingredients/foods in the satiating intervention
- having a pacemaker (for fMRI)
- taking sedatives or sleeping pills
- symptoms of depression (>20 on the BDI).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-restrictive satiating intervention Non-restrictive satiating intervention 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). Conventional restrictive intervention + non-restrictive satiating intervention Conventional restrictive intervention + non-restrictive satiating intervention Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2) Minimal healthy guidelines Control group Considering recommendations from the latest Canadian Obesity Guidelines, the control group will receive a minimal intervention based on the Canada's Food Guide for Healthy Eating
- Primary Outcome Measures
Name Time Method Body weight 6 months Body weight loss (kg) after Phases 1 and 2
Energy intake 6 months measured at an ad libitum meal in kilocalories
Body composition 6 months Body fat (using dual x-ray absorptiometry)
Hunger/Satiety 6 months using a visual analogue scale and measured in mm
- Secondary Outcome Measures
Name Time Method Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol) 18 months measured in mmol/L
Diet satisfaction 18 months Diet Satisfaction Questionnaire (scale: strongly disagree to strongly agree)
Stress 18 months State-Trait Anxiety Inventory
Anxiety 18 months Perceived Stress Scales
Depression Symptoms 18 months Beck Depression Inventory
Eating Behaviours 18 months Three Factor Eating Behaviour Questionnaire
Blood pressure 18 months mmHg
neurobehavioural variables 6 months brain anatomy and activity in response to food cues (using fMRI)
Trial Locations
- Locations (1)
Department of Physical Education
🇨🇦Québec, Quebec, Canada