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| Name | Class |
|---|---|
| University of Ottawa | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-restrictive satiating intervention | Experimental | 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). |
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| Conventional restrictive intervention + non-restrictive satiating intervention | Experimental | Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2) |
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| Minimal healthy guidelines | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-restrictive satiating intervention | Other | Diet group containing satiating foods |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stress | State-Trait Anxiety Inventory | 18 months |
| Anxiety | Perceived Stress Scales | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
The research questions will take into account sex and gender as we consider: (i) restrictive and non-restrictive approaches that may have different impacts on body weight between men and women; and (ii) the impact of these interventions may have different outcomes on behavioural and psychosocial variables. Therefore, participants may be able to indicate their gender identity.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicky Drapeau, PhD | Contact | 4186562131 | vicky.drapeau@fse.ulaval.ca | |
| Lucie Brunelle, MSc, RD | Contact | 4186562131 | lucie.brunelle@kin.ulaval.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Education | Recruiting | Québec | Quebec | G1V0A6 | Canada |
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(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
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Blinding participants is not possible due to the nature of the interventions. Individuals independent from the study and blinded to groups (e.g. statistician), will conduct the randomization and analyses while a research assistant, instructed not to discuss treatments with participants, will conduct the testing sessions.
| Conventional restrictive intervention + non-restrictive satiating intervention | Other | Diet group with a calorie deficit during the first phase followed by a diet containing satiating foods in the second phase |
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| Control group | Other | This group will receive minimal healthy guidelines |
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| 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 |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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