Satiating Diet, Appetite Control and Body Weight Loss in Individuals With Obesity

Study Overview
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Brief Summary
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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.

Official Title
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Non-restrictive Approach to Facilitate Appetite Control and Long-term Body Weight Loss in Individuals With Obesity: Can we do Better?

Conditions
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Weight Loss, Weight Maintenance, Appetite Control

Intervention / Treatment
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* Other: Non-restrictive satiating intervention
* Other: Conventional restrictive intervention + non-restrictive satiating intervention
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: (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). *P1=phase 1; P2=phase 2
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-restrictive satiating intervention<br>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). | Other: Non-restrictive satiating intervention<br>* Diet group containing satiating foods<br>|
| Experimental: Conventional restrictive intervention + non-restrictive satiating intervention<br>Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2) | Other: Conventional restrictive intervention + non-restrictive satiating intervention<br>* Diet group with a calorie deficit during the first phase followed by a diet containing satiating foods in the second phase<br>|
| Placebo Comparator: Minimal healthy guidelines<br>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 | Other: Control group<br>* This group will receive minimal healthy guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight loss (kg) after Phases 1 and 2 | 6 months | 
| Body composition | Body fat (using dual x-ray absorptiometry) | 6 months | 
| Hunger/Satiety | using a visual analogue scale and measured in mm | 6 months | 
| Energy intake | measured at an ad libitum meal in kilocalories | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress | State-Trait Anxiety Inventory | 18 months | 
| Anxiety | Perceived Stress Scales | 18 months | 
| Eating Behaviours | Three Factor Eating Behaviour Questionnaire | 18 months | 
| Depression Symptoms | Beck Depression Inventory | 18 months | 
| Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol) | measured in mmol/L | 18 months | 
| Blood pressure | mmHg | 18 months | 
| Diet satisfaction | Diet Satisfaction Questionnaire (scale: strongly disagree to strongly agree) | 18 months | 
| neurobehavioural variables | brain anatomy and activity in response to food cues (using fMRI) | 6 months |